更新于：2024-11-04
RepliCel Life Sciences, Inc.
更新于：2024-11-04
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标签
神经系统疾病
皮肤和肌肉骨骼疾病
其他疾病
干细胞疗法
关联
1
项与 RepliCel Life Sciences, Inc. 相关的药物靶点 |
作用机制 胶原蛋白I调节剂 |
在研适应症 |
非在研适应症- |
最高研发阶段临床1期 |
首次获批国家/地区- |
首次获批日期- |
4
项与 RepliCel Life Sciences, Inc. 相关的临床试验Randomized, Double-blind, Placebo-controlled, Single-centre, Phase I Safety Study of Intradermal Injections of RCS-01 in Male and Female Subjects (50 to 65 Years Old)
The primary purpose of this study is to assess the safety profile of RCS-01 injections as compared to placebo injections. This study will also measure the impact these injections will have on skin markers related to aging through evaluation of gene expression profiles.
30 participants will be selected for this study based on their health status, current/past medications, and ability to adhere to protocol-related requirements. At the first visit and after providing informed consent, participants are evaluated against the study inclusion/exclusion criteria and provide blood samples for screening assessments (including virology). If suitable for study participation, participants will provide a biopsy from the scalp from which RCS-01 will be prepared and will have four treatment evaluation sites identified on their buttocks, two on each side.
Study participants will be randomized to one of two treatment subgroups. Participants in the RCS-01 Subgroup (n=24) will receive injections of RCS-01 or placebo or a 'sham' injection (a needle penetration without injection of liquid). Participants in the the Placebo Subgroup (n= 6) will be randomized to receive only injections of placebo or sham injections.
Baseline evaluations of subjects' overall health and skin condition at treatment sites on their buttocks will be performed before receipt of injections at Day 0. In addition to injections delivered at Day 0, the pre-selected treatment evaluation sites will receive intradermal injections of RCS-01 or placebo (cryomedium) or a sham injection four (4) and eight (8) weeks after Day 0 according to a randomization schedule for a total of three (3) injections per treatment site.
All participants will return to the clinic for at least 9 visits during the 52-week follow-up period to monitor long-term safety. At the 12-week time point, 18 randomly-selected participants from the RCS-01 Subgroup will provide biopsies from all injection sites for analysis of skin markers related to aging. At the 26-week time point, the remaining participants will provide biopsies of all injection sites for histopathological analysis.
30 participants will be selected for this study based on their health status, current/past medications, and ability to adhere to protocol-related requirements. At the first visit and after providing informed consent, participants are evaluated against the study inclusion/exclusion criteria and provide blood samples for screening assessments (including virology). If suitable for study participation, participants will provide a biopsy from the scalp from which RCS-01 will be prepared and will have four treatment evaluation sites identified on their buttocks, two on each side.
Study participants will be randomized to one of two treatment subgroups. Participants in the RCS-01 Subgroup (n=24) will receive injections of RCS-01 or placebo or a 'sham' injection (a needle penetration without injection of liquid). Participants in the the Placebo Subgroup (n= 6) will be randomized to receive only injections of placebo or sham injections.
Baseline evaluations of subjects' overall health and skin condition at treatment sites on their buttocks will be performed before receipt of injections at Day 0. In addition to injections delivered at Day 0, the pre-selected treatment evaluation sites will receive intradermal injections of RCS-01 or placebo (cryomedium) or a sham injection four (4) and eight (8) weeks after Day 0 according to a randomization schedule for a total of three (3) injections per treatment site.
All participants will return to the clinic for at least 9 visits during the 52-week follow-up period to monitor long-term safety. At the 12-week time point, 18 randomly-selected participants from the RCS-01 Subgroup will provide biopsies from all injection sites for analysis of skin markers related to aging. At the 26-week time point, the remaining participants will provide biopsies of all injection sites for histopathological analysis.
开始日期2015-10-10 |
申办/合作机构 |
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RCT-01 in Men and Women With Unilateral, Chronic Achilles Tendinosis
The primary purpose of this study is to assess the safety profile of RCT-01 injections as compared to placebo injections. This study will also measure the impact these injections will have on tendon structure and function and the symptoms of Achilles tendinosis.
28 participants will be selected for this study based on their health status, current/past medications, and ability to adhere to protocol-related requirements. Prior to entering the screening phase of the study, all potential study participants will have had to have at least 3 months of therapy for their unilateral, chronic (symptoms >6 months) Achilles tendinosis directed by a certified physiotherapist without a clinical response. At the first visit and after providing informed consent participants are evaluated against the study inclusion/exclusion criteria and provide blood samples for screening assessments (including virology). If suitable for study participation, participants will provide a biopsy from the scalp from which RCT-01 will be prepared.
Baseline evaluations of participants' overall health and tendinosis, in particular, will be performed on the day of injection. Once all baseline assessments have been completed, the tendon to be treated will be anesthetized and will receive ultrasound-guided injections of either placebo (cryomedium) or RCT-01.
All participants will return to the clinic for repeat assessments of their unilateral Achilles tendinosis and overall health at seven (7) visits over the following 6 months. Participants will also complete an eccentric training physiotherapy program under the guidance of a certified physiotherapist for two (2) months after receipt of injections. Total duration of patient participation is approximately eight (8) months.
28 participants will be selected for this study based on their health status, current/past medications, and ability to adhere to protocol-related requirements. Prior to entering the screening phase of the study, all potential study participants will have had to have at least 3 months of therapy for their unilateral, chronic (symptoms >6 months) Achilles tendinosis directed by a certified physiotherapist without a clinical response. At the first visit and after providing informed consent participants are evaluated against the study inclusion/exclusion criteria and provide blood samples for screening assessments (including virology). If suitable for study participation, participants will provide a biopsy from the scalp from which RCT-01 will be prepared.
Baseline evaluations of participants' overall health and tendinosis, in particular, will be performed on the day of injection. Once all baseline assessments have been completed, the tendon to be treated will be anesthetized and will receive ultrasound-guided injections of either placebo (cryomedium) or RCT-01.
All participants will return to the clinic for repeat assessments of their unilateral Achilles tendinosis and overall health at seven (7) visits over the following 6 months. Participants will also complete an eccentric training physiotherapy program under the guidance of a certified physiotherapist for two (2) months after receipt of injections. Total duration of patient participation is approximately eight (8) months.
开始日期2015-05-01 |
申办/合作机构 |
Randomized, Single-centre, Double-blind, Placebo-controlled, Phase I / IIa Study to Evaluate the Safety and Efficacy of Human Autologous Hair Follicle Dermal Sheath Cup Cells (DSCC) in Women and Men With Androgenetic Alopecia.
The primary purpose of this study is to assess the safety of performing injections of human autologous hair follicle cells. The study will also measure the impact these injections will have on hair growth.
20 patients will be selected for participation in this study (10 males and 10 females) based on their health status, current/past medications, and ability to adhere to protocol-related requirements. All patients will have evidence of mild to moderate androgenetic alopecia (AGA) involving the vertex area of the scalp as defined by the Ludwig (female) or Norwood (male) scales.
At the first visit and after completing informed consent, patients provide a blood sample that will be tested for human immunodeficiency virus (HIV), hepatitis, and syphilis one week before having a biopsy from the back of their scalp. The provided scalp biopsy is then processed to isolate hair follicle cells which are then replicated. Patients return to the clinic for injections of their own replicated cells (autologous cells) in medium (verum) and medium alone (control) into two pre-selected treatment areas in their scalp. Assessments of the safety/tolerability of these injections will take place over the next 60 months both at in-clinic visits and telephone follow-up visits. At these visits patients will have their overall health assessed as subjective and objective assessments of the areas that were injected either with verum or control. During the first 24 months of follow-up, digital images will be taken of the scalp and of the two treatment areas injected with either verum or control. Furthermore at 6, 12, and 24 months post-injection, four patients (2 male and 2 female) at each time point will provide biopsies of the injection sites for histopathological analysis. At the 60 month time point, any patients not previously providing biopsies for histopathological analysis will provide biopsies. Total duration of patient participation is approximately 63 months.
20 patients will be selected for participation in this study (10 males and 10 females) based on their health status, current/past medications, and ability to adhere to protocol-related requirements. All patients will have evidence of mild to moderate androgenetic alopecia (AGA) involving the vertex area of the scalp as defined by the Ludwig (female) or Norwood (male) scales.
At the first visit and after completing informed consent, patients provide a blood sample that will be tested for human immunodeficiency virus (HIV), hepatitis, and syphilis one week before having a biopsy from the back of their scalp. The provided scalp biopsy is then processed to isolate hair follicle cells which are then replicated. Patients return to the clinic for injections of their own replicated cells (autologous cells) in medium (verum) and medium alone (control) into two pre-selected treatment areas in their scalp. Assessments of the safety/tolerability of these injections will take place over the next 60 months both at in-clinic visits and telephone follow-up visits. At these visits patients will have their overall health assessed as subjective and objective assessments of the areas that were injected either with verum or control. During the first 24 months of follow-up, digital images will be taken of the scalp and of the two treatment areas injected with either verum or control. Furthermore at 6, 12, and 24 months post-injection, four patients (2 male and 2 female) at each time point will provide biopsies of the injection sites for histopathological analysis. At the 60 month time point, any patients not previously providing biopsies for histopathological analysis will provide biopsies. Total duration of patient participation is approximately 63 months.
开始日期2010-12-01 |
申办/合作机构 |
100 项与 RepliCel Life Sciences, Inc. 相关的临床结果
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0 项与 RepliCel Life Sciences, Inc. 相关的专利（医药）
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1
项与 RepliCel Life Sciences, Inc. 相关的文献（医药）2020-01-01·Skin pharmacology and physiology
Autologous Cell Therapy for Aged Human Skin: A Randomized, Placebo-Controlled, Phase-I Study
Article
作者: Marini, Alessandra ; Grether-Beck, Susanne ; Krutmann, Jean ; McElwee, Kevin John ; Hoffmann, Rolf ; Goessens-Rück, Petra ; Jaenicke, Thomas
Introduction: Skin ageing involves senescent fibroblast accumulation, disturbance in extracellular matrix (ECM) homeostasis, and decreased collagen synthesis. Objective: to assess a cell therapy product for aged skin (RCS-01; verum) consisting of ~25 × 106 cultured, autologous cells derived from anagen hair follicle non-bulbar dermal sheath (NBDS). Methods: For each subject in the verum group, 4 areas of buttock skin were injected intradermally 1 or 3 times at monthly intervals with RCS-01, cryomedium, or needle penetration without injection; in the placebo group RCS-01 was replaced by cryomedium. The primary endpoint was assessment of local adverse event profiles. As secondary endpoints, expression of genes related to ECM homeostasis was assessed in biopsies from randomly selected volunteers in the RCS-01 group taken 4 weeks after the last injection. Results: Injections were well tolerated with no severe adverse events reported 1 year after the first injection. When compared with placebo-treated skin, a single treatment with RCS-01 resulted in a significant upregulation of TGFβ1, CTGF, COL1A1, COL1A2, COL3A1, and lumican mRNA expression. Limitations: The cohort size was insufficient for dose ranging evaluation and subgroup analyses of efficacy. Conclusions: RCS-01 therapy is well tolerated and associated with a gene expression response consistent with an improvement of ECM homeostasis.
17
项与 RepliCel Life Sciences, Inc. 相关的新闻（医药）2024-03-14
DUBLIN, March 13, 2024 /PRNewswire/ -- The "Royalty Rates in Pharmaceutical and Biotechnology Deals" report has been added to
ResearchAndMarkets.com's offering.
Royalty Rates in Pharmaceutical and Biotechnology Deals is your one-stop source for providing real-deal information on hundreds of transactions, including the technology licensed, royalty rates, license fees, upfront and milestone payments.
This report provides details of the latest partnering deals which disclose a royalty rate, announced in the pharmaceutical, biotechnology and diagnostic sectors. The report provides details of partnering deals disclosing royalty rates from 2010 to 2024.
The report provides an overview of how and why companies enter partnering deals where a royalty is payable upon commercialization of the compound or technology.
Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not.
This report contains a comprehensive listing of all partnering deals announced since 2010 where a quantitative royalty rate has been disclosed, as recorded in the Current Agreements deals and alliances database. Each deal record and royalty disclosure is available in further detail via a link to online copy of the deal including actual contract document, where available, as submitted to the Securities Exchange Commission by companies and their partners.
The initial chapters of this report provide an orientation of royalty rate trends in pharma and biotech since 2010. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in royalty rates in the pharma and biotech sectors since 2010.
Chapter 3 provides a more detailed insight into the structure of a royalty rate clause and how it fits with the other financial terms of the partnering deal.
Chapter 4 provides an insight into companies active in disclosing royalty rates as well as those deals attracting the highest royalty rates.
Chapter 5 provides comprehensive and detailed access to deals which disclose a royalty rate since 2010 where a contract document is available. Contract documents provide an in-depth insight into the actual deal terms agreed between the parties with respect to the royalty rate.
In addition the report includes a comprehensive deal directory listing of all deals where a royalty rate has been disclosed announced since 2010. Each listing is organized as a directory by company A-Z, stage of development at signing, therapeutic area, and technology type. Each deal title links via hyperlink to an online version of the deal record including, where available, the actual contract document.
The report also includes numerous table and figures that illustrate the trends in royalty rates in pharma and biotech deal making since 2010. In conclusion, this report provides everything a prospective dealmaker needs to know about royalty rates in the pharma and biotech sector.
Royalty Rates in Pharmaceutical and Biotechnology Deals provides the following benefits:
Understand royalty rate trends since 2010
Analysis of the structure of royalty clauses with real life case studies
Browse collaboration and licensing deals which reveal a royalty rate
Benchmark analysis - identify market value of transactions
Financials terms - upfront, milestone, royalties
Directory of deals by company A-Z, therapy focus and technology type
Access contract documents - insights into deal structures
Due diligence - assess suitability of your proposed deal terms for partner companies
Save hundreds of hours of research time
Analyzing actual contract agreements allows assessment of the following:
What are the precise royalty rates granted?
What is actually granted by the agreement to the partner company?
What exclusivity is granted?
What is the payment structure for the deal?
How are sales and payments audited?
What is the deal term?
How are the key terms of the agreement defined?
How are IPRs handled and owned?
Who is responsible for commercialization?
Who is responsible for development, supply, and manufacture?
How is confidentiality and publication managed?
How are disputes to be resolved?
Under what conditions can the deal be terminated?
What happens when there is a change of ownership?
What sublicensing and subcontracting provisions have been agreed?
Which boilerplate clauses does the company insist upon?
Which boilerplate clauses appear to differ from partner to partner or deal type to deal type?
Which jurisdiction does the company insist upon for agreement law?
Key Topics Covered:
Executive Summary
Chapter 1 - Introduction
1.1. What are royalties?
1.2. History of royalty rates
1.3. Royalties in pharmaceuticals and biotechnology
1.4. Royalties versus revenue share
1.5. Overview of the report
Chapter 2 - An overview of pharmaceutical and biotechnology royalty rates
2.1. Trends in royalty rates 2010 - 2024
2.2. How do revenue shares figure?
2.3. A review of recent literature
2.4. Royalty rates in the future
Chapter 3 - The royalty clause in pharmaceutical and biotechnology deals
3.1. Partnering agreement structure
3.2. Structure of a typical royalty clause
3.3. Example royalty clauses
3.3.1. Case study 1
3.3.2. Case study 2
3.3.3. Case study 3
3.3.4. Case study 4
Chapter 4 - Companies actively disclosing royalty rates
4.1. Most active companies in disclosing royalty rates
Chapter 5 - Royalty rate contract directory
Explore royalty rates within the deal contract document to gain greater insight
Deal directory
Deal Directory - Royalty rates in deals - by company A-Z
Deal Directory - Royalty rates in deals - by therapy area
Deal Directory - Royalty rates in deals - by stage of development at signing
Deal Directory - Royalty rates in deals - by technology type
Royalty rate references
Example royalty rate deal contract document
List of Figures
Figure 1: Trends in pharma and biotech royalty rates, 2010 - 2024
Figure 2: Components of the partnering deal structure
Figure 3: Components of the partnering royalty clause
Figure 4: Most active companies disclosing royalty rate 2010 - 2024
Figure 5: Licensing agreement for rhAAT - rEVO Biologics, LFB Biotechnologies
Companies Mentioned
2seventy bio
3a-diagnostics
3D Medicines
4SC
23andMe
Abbott Laboratories
Abbvie
Abeona Therapeutics
Ablynx
Abraxis BioScience
ABVC BioPharma
ACADIA Pharmaceuticals
Acceleron Pharma
Acelrx Pharmaceuticals
Acer Therapeutics
Acerus
Acrotech Biopharma
Actavis (acquired by Watson)
Active Biomaterials
Acura Pharmaceuticals
Adamis Pharmaceuticals
Adaptimmune
ADC Therapeutics
Adeona Pharmaceuticals
Adial Pharmaceuticals
Aditx Therapeutics
Adlai Nortye
Aduro BioTech
Advanced Dosage Forms
Advanz Pharma
Advaxis
Advirna
Aegerion Pharmaceutical
Aeglea BioTherapeutics
Aerie Pharmaceuticals
AEterna Zentaris
Aexon Labs
Affimed Therapeutics
Afritex Medical Products
AFT Pharmaceuticals
Agenus Bio
Agios Pharmaceuticals
Aguettant
AiBtl BioPharma
AIT Therapeutics
Akcea Therapeutics
Akebia Therapeutics
Albert Einstein College of Medicine
Alchemia
Alder Biopharmaceuticals
Alector
Alexion Pharmaceuticals
Alexza Pharmaceuticals
Alfasigma
Alfa Wassermann
Allergan
Allergan (name changed from Actavis)
Almirall
Alnylam Pharmaceuticals
Alora Pharmaceuticals
Alpha Biopharma
Alternavida
Altman Enterprises
AltrazealTrading
Altum Pharmaceuticals
Alvogen
Amarantus BioSciences
American Type Culture Collection (ATCC)
Amgen
Amherst Pharmaceuticals
Amorfix Life Sciences
Ampio Pharmaceuticals
Amryt Pharma
Amylin Pharmaceuticals
Amyris
AnaBios
AnaptysBio
AnGes MG
Angion Biomedica
AnnaMed
Antares Pharma
Antibe Therapeutics
Antigen Express
Applied Therapeutics
Apricus Biosciences
Aquestive Therapeutics
Aradigm
Aratana Therapeutics
Arcellx
Arch Pharmalabs
Arctic Vision
Arcturus Therapeutics
Arcus Biosciences
Ardelyx
Arena Pharmaceuticals
Arrowhead Pharmaceuticals
Artiva Biotherapeutics
Arvinas
Ascendis Pharma
Ascentage Pharma
Ashvattha Therapeutics
Assembly Biosciences
Astellas Pharma
Astellas Pharma Europe
Asterias Biotherapeutics
AstraZeneca
Athenex
Atossa Therapeutics
Atreca
Audeo Oncology
Augmenta
Aurigene Discovery Technologies
Aurinia Pharmaceuticals
Authentic Brands Group
AVEO Oncology
Avita Therapeutics
Avivagen
Axovant Gene Therapies
Axsome Therapeutics
Aytu BioPharma
Azaya Therapeutics
Azure Biotech
Baker Brothers Investments
BAKX Therapeutics
Baliopharm
BASF
Baxter International
Bayer Healthcare
Bayer Innovation
Baylor Research Institute
Beam Therapeutics
BeiGene
Beijing Defengrei Biotechnology
Belgian Volition
Bellerophon Therapeutics
Benitec Biopharma
Besins Healthcare
Beth Israel Deaconess Medical Center
BetterLife Pharma
Bharat Biotech
BIND Biosciences
BioCorRx
BioCryst Pharmaceuticals
Bioeq IP
Biogen
BioGene Technology
Biohaven Pharmaceuticals
BioInvent
BiolineRX
BioMarin Pharmaceutical
BioNovion
BioNTech
BioNxt Solutions
Biopharmex
BiopharmX
BioPorto
Bioprocess Capital Ventures
BioProspect
Biostem US
Biotech Investment
Biotechnology Value Fund
BioTime Acquisition
Bioton
Biovail
BioZone Laboratories
BioZone Pharmaceuticals
Blackstone
Bluebird Bio
Blueprint Medicines
BMV Medica
Boehringer Ingelheim
Bone Therapeutics
Braeburn Pharmaceuticals
BrainStorm Cell Therapeutics
Breathtec BioMedical
Brickell Biotech
BridgeBio Pharma
Bridge Biotherapeutics
Bristol-Myers Squibb
Caleco Pharma
Calico
Can-Fite BioPharma
Cancer Prevention Pharmaceuticals
Cannassure Therapeutics
CanniMed Therapeutics
Cann Pharmaceutical Australia
Canntab Therapeutics
Cannus Partners
Cantex Pharmaceuticals
Cara Therapeutics
Cardigant Medical
Cardium Therapeutics
CareFusion
Carna BioSciences
Cary Pharmaceuticals
CASI Pharmaceuticals
Castle Creek Biosciences
Catalent
CB2 Therapeutics
Celdara Medical
Celgene
Cell Cure Neurosciences
Cellvera
Cel Sci
Celyad
Cereal Ingredients
Cerebain Biotech
Cerus
CGA 369
cGreen
Chi-Med
Chiesi Farmaceutici
Chimerix
Chong Kun Dang
Chongqing Jingdong Pharmaceutical
Cimtech
Cipher Pharmaceuticals
Cipla
Circassia
Clal Biotech
Clalit Health Services
Clearmind Medicine
Clearside Biomedical
Clemson University
Cleveland BioLabs
Clinigen
CMIC
CNS Pharmaceuticals
Cocrystal Pharma
Coeptis Pharmaceuticals
CohBar
Cohen-McNiece Foundation
Coherus Biosciences
Colby Pharmaceuticals
Collegium Pharmaceuticals
Columbia Laboratories
Columbia University
Common Sense
Conatus Pharmaceuticals
Concile
Consilient Health
ContraFect
Coronado Biosciences
Cosmofix
Cosmo Pharmaceuticals
Coya Therapeutics
CRISPR Therapeutics
Crossject
Crucell
CSL
CTI BioPharma
CTT Pharmaceutical
Cullinan Oncology
Cumberland Pharmaceuticals
Cures Within Reach
CureTech
Curis
Currax Pharmaceuticals
CURx Pharmaceuticals
Cutanea Life Sciences
Cybin
CymaBay Therapeutics
Cypress Bioscience
Cytodyn
Cytokinetics
Cytori Therapeutics
Daewoong Pharmaceutical
Daiichi Sankyo
Dana-Farber Cancer Institute
Dance Biopharm
DAS Therapeutics
Defiante Farmaceutica
Denali Therapeutics
DepoMed
Derma Sciences
Dermavant Sciences
Dermin
Dianomi Therapeutics
Dicerna Pharmaceuticals
DNA Biomedical Solutions
Dr. Falk Pharma
Dr. Reddy's Laboratories
Dragonfly Therapeutics
DRI Capital
Drugs for Neglected Diseases Initiative
DS Healthcare
Duke University
Dyax
Eagle Pharmaceuticals
Eagle Pharmaceuticals (US)
Easton Pharmaceuticals
Echo Therapeutics
Ecology Coatings
Eczacibasi Pharmaceuticals
Eddingpharm
Egalet
Eisai
Elencee
Eli Lilly
Elite Pharmaceuticals
Emergent BioSolutions
Emory University
Enalare Therapeutics
Endocyte
Endo Pharmaceuticals
EnGeneIC
Enochian Biosciences
Entera Bio
Entest BioMedical
EnWave
Epizyme
Epocal
Esperion Therapeutics
Eternity Healthcare
Eton Pharmaceuticals
Eureka Genomics
EUSA Pharma
Evolva
Ewopharma
Exact Sciences
Exelixis
ExScientia
Eyevance
Fairview Health System
FasTrack Pharmaceuticals
Ferozsons Laboratories
Ferring Pharmaceuticals
Fibrocell Science
Foghorn Therapeutics
Forest Laboratories
Fosun Pharmaceutical
Fox Chase Chemical Diversity Center
Fresenius Kabi Pharmaceuticals
FSD Pharma
Fusion Pharmaceuticals
FusionVax
Galapagos
Galmed Pharmaceuticals
GE Healthcare
Genentech
Generex Biotechnology
Genevant Sciences
Genexine
Genfit
Genmab
Gentium
Genzyme
Geron
Gilead Sciences
Glaukos
Glenmark Generics Inc USA
Glenmark Pharmaceuticals
Goldfinch Bio
Government of Israel
GPCR Therapeutics
Gravocore
Grifols
GSK
GT Biopharma
Hai Kang Life
Hail First Pharma
Hainan Sihuan Pharmaceutical
Halo Labs
Halozyme Therapeutics
Hansen Medical
Health Canada
Healthcare Royalty Partners
Health Discovery
Heartseed
Heat Biologics
Hefei Life Science
Hefei Tianhui Incubation of Technologies
HekaBio
Helsinn Therapeutics
HemoCleanse
Hemogenyx
HemPup
Henlius Biotech
Hetero Labs
HIBM Research Group
Hikma Pharmaceuticals
Hoffmann La Roche
Hollister Biosciences
Hookipa Pharma
Horizon Pharma Inc
Huadong Medicine
HyperGenomics
I-mab
Icahn School of Medicine at Mount Sinai
Ice + Jam
Iconovo
IDC-GP Pharm
IDEAYA Biosciences
Idera Pharmaceuticals
Idorsia
Idun Pharmaceuticals
IGM Biosciences
iMetabolic Biopharma
Immugenyx
Immunic
ImmunityBio
Immunomedics
Immunomic Therapeutics
Immunovative Therapies
ImmVira
Impax Laboratories
Imprimis Pharmaceuticals
In4Derm
iNAP
Incannex Healthcare
Incuron
Incyte
Indiana University
Infinity Pharmaceuticals
InflaRx
Inhibitor Therapeutics
Innate Pharma
Innocoll
Innovate Biopharmaceuticals
Innovation Pharmaceuticals
Innovent Biologics
Innovet
Innovus Pharmaceuticals
INO Therapeutics
Inspiration Biopharmaceuticals
Instrumentation Laboratory
IntelGenx
Intellia Therapeutics
IntelliCell BioSciences
Intellikine
Internet Marketing Consortium
Intrexon
Intuitive Surgical
Invekra
Inverness Medical Innovations
Ionis Pharmaceuticals
Ipsen
Iroko Pharmaceuticals
Ironwood Pharmaceuticals
Israeli National Authority for Technological Innovation
Itrom Pharmaceutical Group
Ivantis
Jaguar Health
Janssen Biotech
Janssen Pharmaceuticals
Jazz Pharmaceuticals
JFC Technologies
Jiangsu Alphamab
Jiangsu Lianhuan Pharmaceuticals
Jiangsu NHWA Pharmaceutical
Ji Xing Pharmaceuticals
John Morley Foods
Joincare Pharmaceutical
Journey Medical
Jubilant Life Sciences
Jumpcan Pharmaceutical
Juniper Pharmaceuticals
Junshi Biosciences
Jupiter Wellness
Juventas Therapeutics
K2M
Kadmon Pharmaceuticals
Kaken Pharmaceutical
Kalbe Genexine Biologics
KaloBios Pharmaceuticals
Karveer Meditech
KemPharm
Kensey Nash
Kieran Murphy
Kinetic Concepts
Kiniksa Pharmaceuticals
Kintor
Kiromic Biopharma
Kite Pharma
Kitov Pharma
Klaria
Klinge Biopharma
Knighton Foods
Knight Therapeutics
Kodiak Sciences
Kowa
Kraig Biocraft Laboratories
KVK-Tech
Kwang Dong Pharmaceutical
Kymera Therapeutics
Kyowa Hakko Kirin
Kyverna Therapeutics
L1 Systems
Laboratories Acbel
Lantheus Holding
Launch Therapeutics
Lee Moffitt Cancer Center
Legend Biotech
LegoChem Biosciences
Level Brands
LFB Biotechnologies
Lifestyle Delivery Systems
Ligand Pharmaceuticals
Lineage Cell Therapeutics
Link Health
Lipidor
Lipocine
Lixte Biotechnology
Lorna Linda University
Lotus Pharmaceuticals
Loxo Oncology
Lubrizol
Lumenis
Lundbeck
Lung Therapeutics
MabCure
Macrogenics
Magenta Therapeutics
MainPointe
Mallinckrodt Pharmaceuticals
Marvanal
Marv Enterprises
Massachusetts General Hospital
Matrix Biomed
Mayne Pharma
McComb Foundation
McEwen Centre for Regenerative Medicine
Meda
Medica
Medica Avante
Medical Technologies Innovation Asia
Medice Arzneimittel Putter
Medicines Patent Pool Foundation
Medicox
MediGene
Medigus
MedImmune
Medison Pharma
Medivation
Medivir
Medovex
MEI Pharma
Melmed
Memory Dx
Mercer University
Merck and Co
Merck KGaA
Merck Serono
Merus
Methodist Hospital Houston
Micromet
Mikah Pharma
Millennium
Mimi's Rock
Mindset Pharma
Ministry of Health
Labor and Welfare
MiNK Therapeutics
Miraculins
Miralogx
Mira Pharmaceuticals
Miromatrix Medical
Mitsubishi Tanabe Pharma
Moderna
Modis Therapeutics
Moleculin Biotech
Mologen
Momenta Pharmaceuticals
Monash University
Monopar Therapeutics
Morgan Stanley
MorphoSys
Mount Sinai Health System
MultiCell Immunotherapeutics
Munich Leukemia Laboratory
Mylan Laboratories
Mylan Pharmaceuticals
Myovant Sciences
NanoVibronix
NanoViricides
NantCell
NantKwest
Nantong Jinghua Pharmaceutical
NantWorks
Napo Pharmaceuticals
Natac Biotech
Natco Pharmaceuticals
National Green Biomed
Nektar Therapeutics
Neogenomics
Neotope
Nephrogenex
Nephros
Nestle Health Science
Neuraxpharm
Neurocrine Biosciences
NeuroRx
NeuroSigma
NeuroVive Pharmaceutical
NeuroVive Pharmaceutical Asia
NewLeaf Brands
Newsoara Biopharma
New York University
NexMed
NextCure
Nextleaf Solutions
Nexvet
NGM Biopharmaceuticals
Nicox
Nkarta Therapeutics
NLS Pharmaceutics
Nordic Bioscience
Norgine
NorthStar Medical Radioisotopes
Notable Labs
Novadaq Technologies
NovaDel Pharma
Novan
Novan Therapeutics
Novartis
Novartis Vaccines and Diagnostics
Novocure
Novo Nordisk
Novus Biologicals
NRx Pharmaceuticals
Nucorion
Numab
Nunzi Pharmaceutical
Nurix Therapeutics
Nutech Medical
NutraOrigin
NXTGEN
Nymox Pharmaceutical
Oberland Capital
Ocugen
Oculus Innovative Sciences
Ocumension Therapeutics
Omeros
Oncologie
Oncolytics Biotech
OncoMed Pharmaceuticals
Onconova Therapeutics
Onegevity
One Way Liver Genomics (OWL)
ONK Therapeutics
Ono Pharmaceutical
Onxeo
Onyx Pharmaceuticals
Opexa Therapeutics
Opthea
OptiBiotix
OptiNose
Oragenics
Oramed Pharmaceuticals
Orexigen Therapeutics
Organovo
Orgenesis
Orion
Orox Pharmaceuticals
OrthoCyte
Otsuka
OvaMed
Ovid Therapeutics
Oxford BioMedica
Oxis Biotech
Oxygen Biotherapeutics
OxySure Systems
Oyster Point Pharma
Pan-Provincial Vaccine Enterprise
Parnell Pharmaceuticals
Par Pharmaceutical
PDL BioPharma
PDS Biotechnology
Penwest Pharmaceuticals
Pernix Therapeutics
Perugia University
Pfenex
Pfizer
Pharmacyclics
PharmaCyte Biotech
PharmaMar
PharmaNova
Pharmastrip
Philogen
Phosphagenics
Photocure ASA
Phusion Laboratoies
Phyto Nutricare
Pipex Pharmaceuticals
Plandai Biotechnology
Pluristem Therapeutics
POINT Biopharma
Portola Pharmaceuticals
Poseida Therapeutics
Pozen
PreMD
Premier Biomedical
Professional Compounding Centers of America
Progenics Pharmaceuticals
Prometic Life Sciences
ProQR Therapeutics
Prosidion
Protagonist Therapeutics
Protalix BioTherapeutics
Proteonomix
Prothena
ProtoKinetix
Pulmatrix
Puma Biotechnology
QED Therapeutics
QRxPharma
Quick Med Technologies
Quigley Corporation
Quoin Pharmaceuticals
Rayner Surgical
Reata Pharmaceuticals
Recordati
Recro Pharma
RedHill Biopharma
Reedy Creek Investments
RegenaStem
Regeneron Pharmaceuticals
Regenxbio
Regnum
Relay Therapeutics
Relief Therapeutics
Relmada Therapeutics
RenalytixAI
ReNeuron
Repare Therapeutics
Replicel Life Sciences
Repligen
Reprise Biomedical
Resarci Therapeutics
Retrophin
rEVO Biologics
Revolution Medicines
Rigel Pharmaceuticals
RNL Bio
Roche
Rockefeller University
Roivant Sciences
Royalty Pharma
RST Biomedikal Sanayi
Ruthigen
RXi Pharmaceuticals
S2 Therapeutics
SACCO
Sagard Healthcare Royalty Partners
Sage Therapeutics
Salix Pharmaceuticals
Sam Amer
Sanara MedTech
Sandoz
Sanofi
Sanofi-Aventis
Sanofi-Pasteur
Sanpellegrino Cosmetics
Santarus
Santen Pharmaceutical
Sanuwave Health
SA Pathology
Sapientia Pharmaceuticals
Sarepta Therapeutics
Schrodinger
Scopus BioPharma
Seagen
Seattle Genetics
Seelos Therapeutics
Sekris Biomedical
Senetek
Senior Paradise
Sensory Cloud
Seqirus
Seres Therapeutics
Sermonix Pharmaceutical
Sesen Bio
SevenScore Pharmaceuticals
Shanghai Pharmaceuticals Holdings
Sheba Medical Center
Shenzhen BioScien Pharmaceuticals
Shield Therapeutics
Shionogi
Shire Pharmaceuticals
Shore Therapeutics
Siemens Healthcare Diagnostics
Sigma-Tau
Sinclair Pharmaceuticals
Sinobiopharma
Sinopharm
Sio Gene Therapies
Skinvera
Skyline Diagnostics
Solarvest BioEnergy
Soliance
Soligenix
Sonoma BioTherapeutics
Sorrento Therapeutics
Spectranetics
Spencer Pharmaceutical
Spinal USA
St. Jude Children's Research Hospital
STADA Arzneimittel
Staidson (Beijing) BioPharmaceuticals
Stanford University
Stealth BioTherapeutics
Stellar Biotechnologies
St Jude Medical
Stoke Therapeutics
Strongbridge Biopharma
Sucampo AG
SUDA Pharmaceuticals
Sumitomo Dainippon Pharma
Sunesis Pharmaceuticals
Sunovion Pharmaceuticals
Sun Pharmaceutical
SuperNova Diagnostics
Sutro Biopharma
Swedish Orphan Biovitrum
SymBio Pharmaceuticals
Symbollon
Syndax Pharmaceuticals
Synergy Strips
Syntopix
Tactical Relief
Taiba
TaiGen Biotechnology
Taiho
Takeda Pharmaceutical
Talaris Therapeutics
Tango Therapeutics
Target Group
Tauriga Sciences
TB Alliance
TearLab
Technion Research and Development Foundation
Teijin
Telomir Pharmaceuticals
Tesaro
Tetra Bio-Pharma
TetraLogic Pharmaceuticals
Teva Pharmaceutical Industries
Texas A&M University
Texas Heart Institute
TFF Pharmaceuticals
TG Therapeutics
Therakine
TherapeuticsMD
Theravance
Theravance Biopharma
The Regents of the University of California
Thorne Research
Threshold Pharmaceuticals
TiGenix
Tilray
Titterington Veterinary Services
Tiziana Life Sciences
Tocagen
TONIX Pharmaceuticals
Torii Pharmaceutical
TRACON Pharmaceuticals
Tramorgan
Transgene
Travere Therapeutics
Trellis Bioscience
Trevena
Trimedyne
Trimeris
TrovaGene
TTFactor
Tufts University
Turnstone Biologics
Tyme Technologies
Ultragenyx Pharmaceuticals
Uluru
Unigene Laboratories
UniQure
Universal Cells
University College Dublin
University Health Network
University of Alberta
University of California
University of Central Florida Research Foundation
University of Colorado
University of Florida Research Foundation
University of Geneva
University of Louisville
University of Missouri
University of Notre of Dame
University of Pennsylvania
University of Texas
University of Virginia
University of Western Sydney
University of Zurich
UOP
Uppsalagruppen Medical
Upstream Peripheral Technologies
UroGen Pharma
Valeant Pharmaceuticals
ValiPharma
Valneva
Valor Biotherapeutics
Vanderbilt University
Vasomune Therapeutics
Vaxent
VBL Therapeutics
Veloxis Pharmaceuticals
Veracyte
Verenium
Verity Pharmaceuticals
VeroScience
Vertex Pharmaceuticals
Vida Concepts
Vifor Pharma
ViiV Healthcare
Virbac
Viropharma
VistaGen Therapeutics
Vividion Therapeutics
Vivus
VolitionRX
Voronoi
Voyager Therapeutics
Vyera Pharmaceuticals
VYNE Therapeutics
Vyrix Pharmaceuticals
Watson Pharmaceuticals
WAVE Life Sciences
Wigen Biomedicine
Wisconsin Alumni Research Foundation
World Class Extractions
WPD Pharmaceuticals
WUGEN
Xbrane Bioscience
Xencor
Xlife Sciences
XPhyto Therapeutics
XTL Biopharmaceuticals
Xynomic Pharmaceuticals
Yale University
Yeda Research and Development Company
Yeugnam University
Yissum Research Development
ZAI Laboratory
Zalicus
Zenitech
Zenith Epigenetics
Ziopharm Oncology
Zogenix
ZS Pharma
Zymeworks
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SOURCE Research and Markets
疫苗并购
2024-03-13
DUBLIN--(
BUSINESS WIRE
)--The
"Royalty Rates in Pharmaceutical and Biotechnology Deals"
report has been added to
ResearchAndMarkets.com's
offering.
Royalty Rates in Pharmaceutical and Biotechnology Deals
is your one-stop source for providing real-deal information on hundreds of transactions, including the technology licensed, royalty rates, license fees, upfront and milestone payments.
This report provides details of the latest partnering deals which disclose a royalty rate, announced in the pharmaceutical, biotechnology and diagnostic sectors. The report provides details of partnering deals disclosing royalty rates from 2010 to 2024.
The report provides an overview of how and why companies enter partnering deals where a royalty is payable upon commercialization of the compound or technology.
Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not.
This report contains a comprehensive listing of all partnering deals announced since 2010 where a quantitative royalty rate has been disclosed, as recorded in the Current Agreements deals and alliances database. Each deal record and royalty disclosure is available in further detail via a link to online copy of the deal including actual contract document, where available, as submitted to the Securities Exchange Commission by companies and their partners.
The initial chapters of this report provide an orientation of royalty rate trends in pharma and biotech since 2010. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in royalty rates in the pharma and biotech sectors since 2010.
Chapter 3 provides a more detailed insight into the structure of a royalty rate clause and how it fits with the other financial terms of the partnering deal.
Chapter 4 provides an insight into companies active in disclosing royalty rates as well as those deals attracting the highest royalty rates.
Chapter 5 provides comprehensive and detailed access to deals which disclose a royalty rate since 2010 where a contract document is available. Contract documents provide an in-depth insight into the actual deal terms agreed between the parties with respect to the royalty rate.
In addition the report includes a comprehensive deal directory listing of all deals where a royalty rate has been disclosed announced since 2010. Each listing is organized as a directory by company A-Z, stage of development at signing, therapeutic area, and technology type. Each deal title links via hyperlink to an online version of the deal record including, where available, the actual contract document.
The report also includes numerous table and figures that illustrate the trends in royalty rates in pharma and biotech deal making since 2010. In conclusion, this report provides everything a prospective dealmaker needs to know about royalty rates in the pharma and biotech sector.
Royalty Rates in Pharmaceutical and Biotechnology Deals provides the following benefits:
Understand royalty rate trends since 2010
Analysis of the structure of royalty clauses with real life case studies
Browse collaboration and licensing deals which reveal a royalty rate
Benchmark analysis - identify market value of transactions
Financials terms - upfront, milestone, royalties
Directory of deals by company A-Z, therapy focus and technology type
Access contract documents - insights into deal structures
Due diligence - assess suitability of your proposed deal terms for partner companies
Save hundreds of hours of research time
Analyzing actual contract agreements allows assessment of the following:
What are the precise royalty rates granted?
What is actually granted by the agreement to the partner company?
What exclusivity is granted?
What is the payment structure for the deal?
How are sales and payments audited?
What is the deal term?
How are the key terms of the agreement defined?
How are IPRs handled and owned?
Who is responsible for commercialization?
Who is responsible for development, supply, and manufacture?
How is confidentiality and publication managed?
How are disputes to be resolved?
Under what conditions can the deal be terminated?
What happens when there is a change of ownership?
What sublicensing and subcontracting provisions have been agreed?
Which boilerplate clauses does the company insist upon?
Which boilerplate clauses appear to differ from partner to partner or deal type to deal type?
Which jurisdiction does the company insist upon for agreement law?
Key Topics Covered:
Executive Summary
Chapter 1 - Introduction
1.1. What are royalties?
1.2. History of royalty rates
1.3. Royalties in pharmaceuticals and biotechnology
1.4. Royalties versus revenue share
1.5. Overview of the report
Chapter 2 - An overview of pharmaceutical and biotechnology royalty rates
2.1. Trends in royalty rates 2010 - 2024
2.2. How do revenue shares figure?
2.3. A review of recent literature
2.4. Royalty rates in the future
Chapter 3 - The royalty clause in pharmaceutical and biotechnology deals
3.1. Partnering agreement structure
3.2. Structure of a typical royalty clause
3.3. Example royalty clauses
3.3.1. Case study 1
3.3.2. Case study 2
3.3.3. Case study 3
3.3.4. Case study 4
Chapter 4 - Companies actively disclosing royalty rates
4.1. Most active companies in disclosing royalty rates
Chapter 5 - Royalty rate contract directory
Explore royalty rates within the deal contract document to gain greater insight
Deal directory
Deal Directory - Royalty rates in deals - by company A-Z
Deal Directory - Royalty rates in deals - by therapy area
Deal Directory - Royalty rates in deals - by stage of development at signing
Deal Directory - Royalty rates in deals - by technology type
Royalty rate references
Example royalty rate deal contract document
List of Figures
Figure 1: Trends in pharma and biotech royalty rates, 2010 - 2024
Figure 2: Components of the partnering deal structure
Figure 3: Components of the partnering royalty clause
Figure 4: Most active companies disclosing royalty rate 2010 - 2024
Figure 5: Licensing agreement for rhAAT - rEVO Biologics, LFB Biotechnologies
Companies Mentioned
2seventy bio
3a-diagnostics
3D Medicines
4SC
23andMe
Abbott Laboratories
Abbvie
Abeona Therapeutics
Ablynx
Abraxis BioScience
ABVC BioPharma
ACADIA Pharmaceuticals
Acceleron Pharma
Acelrx Pharmaceuticals
Acer Therapeutics
Acerus
Acrotech Biopharma
Actavis (acquired by Watson)
Active Biomaterials
Acura Pharmaceuticals
Adamis Pharmaceuticals
Adaptimmune
ADC Therapeutics
Adeona Pharmaceuticals
Adial Pharmaceuticals
Aditx Therapeutics
Adlai Nortye
Aduro BioTech
Advanced Dosage Forms
Advanz Pharma
Advaxis
Advirna
Aegerion Pharmaceutical
Aeglea BioTherapeutics
Aerie Pharmaceuticals
AEterna Zentaris
Aexon Labs
Affimed Therapeutics
Afritex Medical Products
AFT Pharmaceuticals
Agenus Bio
Agios Pharmaceuticals
Aguettant
AiBtl BioPharma
AIT Therapeutics
Akcea Therapeutics
Akebia Therapeutics
Albert Einstein College of Medicine
Alchemia
Alder Biopharmaceuticals
Alector
Alexion Pharmaceuticals
Alexza Pharmaceuticals
Alfasigma
Alfa Wassermann
Allergan
Allergan (name changed from Actavis)
Almirall
Alnylam Pharmaceuticals
Alora Pharmaceuticals
Alpha Biopharma
Alternavida
Altman Enterprises
AltrazealTrading
Altum Pharmaceuticals
Alvogen
Amarantus BioSciences
American Type Culture Collection (ATCC)
Amgen
Amherst Pharmaceuticals
Amorfix Life Sciences
Ampio Pharmaceuticals
Amryt Pharma
Amylin Pharmaceuticals
Amyris
AnaBios
AnaptysBio
AnGes MG
Angion Biomedica
AnnaMed
Antares Pharma
Antibe Therapeutics
Antigen Express
Applied Therapeutics
Apricus Biosciences
Aquestive Therapeutics
Aradigm
Aratana Therapeutics
Arcellx
Arch Pharmalabs
Arctic Vision
Arcturus Therapeutics
Arcus Biosciences
Ardelyx
Arena Pharmaceuticals
Arrowhead Pharmaceuticals
Artiva Biotherapeutics
Arvinas
Ascendis Pharma
Ascentage Pharma
Ashvattha Therapeutics
Assembly Biosciences
Astellas Pharma
Astellas Pharma Europe
Asterias Biotherapeutics
AstraZeneca
Athenex
Atossa Therapeutics
Atreca
Audeo Oncology
Augmenta
Aurigene Discovery Technologies
Aurinia Pharmaceuticals
Authentic Brands Group
AVEO Oncology
Avita Therapeutics
Avivagen
Axovant Gene Therapies
Axsome Therapeutics
Aytu BioPharma
Azaya Therapeutics
Azure Biotech
Baker Brothers Investments
BAKX Therapeutics
Baliopharm
BASF
Baxter International
Bayer Healthcare
Bayer Innovation
Baylor Research Institute
Beam Therapeutics
BeiGene
Beijing Defengrei Biotechnology
Belgian Volition
Bellerophon Therapeutics
Benitec Biopharma
Besins Healthcare
Beth Israel Deaconess Medical Center
BetterLife Pharma
Bharat Biotech
BIND Biosciences
BioCorRx
BioCryst Pharmaceuticals
Bioeq IP
Biogen
BioGene Technology
Biohaven Pharmaceuticals
BioInvent
BiolineRX
BioMarin Pharmaceutical
BioNovion
BioNTech
BioNxt Solutions
Biopharmex
BiopharmX
BioPorto
Bioprocess Capital Ventures
BioProspect
Biostem US
Biotech Investment
Biotechnology Value Fund
BioTime Acquisition
Bioton
Biovail
BioZone Laboratories
BioZone Pharmaceuticals
Blackstone
Bluebird Bio
Blueprint Medicines
BMV Medica
Boehringer Ingelheim
Bone Therapeutics
Braeburn Pharmaceuticals
BrainStorm Cell Therapeutics
Breathtec BioMedical
Brickell Biotech
BridgeBio Pharma
Bridge Biotherapeutics
Bristol-Myers Squibb
Caleco Pharma
Calico
Can-Fite BioPharma
Cancer Prevention Pharmaceuticals
Cannassure Therapeutics
CanniMed Therapeutics
Cann Pharmaceutical Australia
Canntab Therapeutics
Cannus Partners
Cantex Pharmaceuticals
Cara Therapeutics
Cardigant Medical
Cardium Therapeutics
CareFusion
Carna BioSciences
Cary Pharmaceuticals
CASI Pharmaceuticals
Castle Creek Biosciences
Catalent
CB2 Therapeutics
Celdara Medical
Celgene
Cell Cure Neurosciences
Cellvera
Cel Sci
Celyad
Cereal Ingredients
Cerebain Biotech
Cerus
CGA 369
cGreen
Chi-Med
Chiesi Farmaceutici
Chimerix
Chong Kun Dang
Chongqing Jingdong Pharmaceutical
Cimtech
Cipher Pharmaceuticals
Cipla
Circassia
Clal Biotech
Clalit Health Services
Clearmind Medicine
Clearside Biomedical
Clemson University
Cleveland BioLabs
Clinigen
CMIC
CNS Pharmaceuticals
Cocrystal Pharma
Coeptis Pharmaceuticals
CohBar
Cohen-McNiece Foundation
Coherus Biosciences
Colby Pharmaceuticals
Collegium Pharmaceuticals
Columbia Laboratories
Columbia University
Common Sense
Conatus Pharmaceuticals
Concile
Consilient Health
ContraFect
Coronado Biosciences
Cosmofix
Cosmo Pharmaceuticals
Coya Therapeutics
CRISPR Therapeutics
Crossject
Crucell
CSL
CTI BioPharma
CTT Pharmaceutical
Cullinan Oncology
Cumberland Pharmaceuticals
Cures Within Reach
CureTech
Curis
Currax Pharmaceuticals
CURx Pharmaceuticals
Cutanea Life Sciences
Cybin
CymaBay Therapeutics
Cypress Bioscience
Cytodyn
Cytokinetics
Cytori Therapeutics
Daewoong Pharmaceutical
Daiichi Sankyo
Dana-Farber Cancer Institute
Dance Biopharm
DAS Therapeutics
Defiante Farmaceutica
Denali Therapeutics
DepoMed
Derma Sciences
Dermavant Sciences
Dermin
Dianomi Therapeutics
Dicerna Pharmaceuticals
DNA Biomedical Solutions
Dr. Falk Pharma
Dr. Reddy's Laboratories
Dragonfly Therapeutics
DRI Capital
Drugs for Neglected Diseases Initiative
DS Healthcare
Duke University
Dyax
Eagle Pharmaceuticals
Eagle Pharmaceuticals (US)
Easton Pharmaceuticals
Echo Therapeutics
Ecology Coatings
Eczacibasi Pharmaceuticals
Eddingpharm
Egalet
Eisai
Elencee
Eli Lilly
Elite Pharmaceuticals
Emergent BioSolutions
Emory University
Enalare Therapeutics
Endocyte
Endo Pharmaceuticals
EnGeneIC
Enochian Biosciences
Entera Bio
Entest BioMedical
EnWave
Epizyme
Epocal
Esperion Therapeutics
Eternity Healthcare
Eton Pharmaceuticals
Eureka Genomics
EUSA Pharma
Evolva
Ewopharma
Exact Sciences
Exelixis
ExScientia
Eyevance
Fairview Health System
FasTrack Pharmaceuticals
Ferozsons Laboratories
Ferring Pharmaceuticals
Fibrocell Science
Foghorn Therapeutics
Forest Laboratories
Fosun Pharmaceutical
Fox Chase Chemical Diversity Center
Fresenius Kabi Pharmaceuticals
FSD Pharma
Fusion Pharmaceuticals
FusionVax
Galapagos
Galmed Pharmaceuticals
GE Healthcare
Genentech
Generex Biotechnology
Genevant Sciences
Genexine
Genfit
Genmab
Gentium
Genzyme
Geron
Gilead Sciences
Glaukos
Glenmark Generics Inc USA
Glenmark Pharmaceuticals
Goldfinch Bio
Government of Israel
GPCR Therapeutics
Gravocore
Grifols
GSK
GT Biopharma
Hai Kang Life
Hail First Pharma
Hainan Sihuan Pharmaceutical
Halo Labs
Halozyme Therapeutics
Hansen Medical
Health Canada
Healthcare Royalty Partners
Health Discovery
Heartseed
Heat Biologics
Hefei Life Science
Hefei Tianhui Incubation of Technologies
HekaBio
Helsinn Therapeutics
HemoCleanse
Hemogenyx
HemPup
Henlius Biotech
Hetero Labs
HIBM Research Group
Hikma Pharmaceuticals
Hoffmann La Roche
Hollister Biosciences
Hookipa Pharma
Horizon Pharma Inc
Huadong Medicine
HyperGenomics
I-mab
Icahn School of Medicine at Mount Sinai
Ice + Jam
Iconovo
IDC-GP Pharm
IDEAYA Biosciences
Idera Pharmaceuticals
Idorsia
Idun Pharmaceuticals
IGM Biosciences
iMetabolic Biopharma
Immugenyx
Immunic
ImmunityBio
Immunomedics
Immunomic Therapeutics
Immunovative Therapies
ImmVira
Impax Laboratories
Imprimis Pharmaceuticals
In4Derm
iNAP
Incannex Healthcare
Incuron
Incyte
Indiana University
Infinity Pharmaceuticals
InflaRx
Inhibitor Therapeutics
Innate Pharma
Innocoll
Innovate Biopharmaceuticals
Innovation Pharmaceuticals
Innovent Biologics
Innovet
Innovus Pharmaceuticals
INO Therapeutics
Inspiration Biopharmaceuticals
Instrumentation Laboratory
IntelGenx
Intellia Therapeutics
IntelliCell BioSciences
Intellikine
Internet Marketing Consortium
Intrexon
Intuitive Surgical
Invekra
Inverness Medical Innovations
Ionis Pharmaceuticals
Ipsen
Iroko Pharmaceuticals
Ironwood Pharmaceuticals
Israeli National Authority for Technological Innovation
Itrom Pharmaceutical Group
Ivantis
Jaguar Health
Janssen Biotech
Janssen Pharmaceuticals
Jazz Pharmaceuticals
JFC Technologies
Jiangsu Alphamab
Jiangsu Lianhuan Pharmaceuticals
Jiangsu NHWA Pharmaceutical
Ji Xing Pharmaceuticals
John Morley Foods
Joincare Pharmaceutical
Journey Medical
Jubilant Life Sciences
Jumpcan Pharmaceutical
Juniper Pharmaceuticals
Junshi Biosciences
Jupiter Wellness
Juventas Therapeutics
K2M
Kadmon Pharmaceuticals
Kaken Pharmaceutical
Kalbe Genexine Biologics
KaloBios Pharmaceuticals
Karveer Meditech
KemPharm
Kensey Nash
Kieran Murphy
Kinetic Concepts
Kiniksa Pharmaceuticals
Kintor
Kiromic Biopharma
Kite Pharma
Kitov Pharma
Klaria
Klinge Biopharma
Knighton Foods
Knight Therapeutics
Kodiak Sciences
Kowa
Kraig Biocraft Laboratories
KVK-Tech
Kwang Dong Pharmaceutical
Kymera Therapeutics
Kyowa Hakko Kirin
Kyverna Therapeutics
L1 Systems
Laboratories Acbel
Lantheus Holding
Launch Therapeutics
Lee Moffitt Cancer Center
Legend Biotech
LegoChem Biosciences
Level Brands
LFB Biotechnologies
Lifestyle Delivery Systems
Ligand Pharmaceuticals
Lineage Cell Therapeutics
Link Health
Lipidor
Lipocine
Lixte Biotechnology
Lorna Linda University
Lotus Pharmaceuticals
Loxo Oncology
Lubrizol
Lumenis
Lundbeck
Lung Therapeutics
MabCure
Macrogenics
Magenta Therapeutics
MainPointe
Mallinckrodt Pharmaceuticals
Marvanal
Marv Enterprises
Massachusetts General Hospital
Matrix Biomed
Mayne Pharma
McComb Foundation
McEwen Centre for Regenerative Medicine
Meda
Medica
Medica Avante
Medical Technologies Innovation Asia
Medice Arzneimittel Putter
Medicines Patent Pool Foundation
Medicox
MediGene
Medigus
MedImmune
Medison Pharma
Medivation
Medivir
Medovex
MEI Pharma
Melmed
Memory Dx
Mercer University
Merck and Co
Merck KGaA
Merck Serono
Merus
Methodist Hospital Houston
Micromet
Mikah Pharma
Millennium
Mimi's Rock
Mindset Pharma
Ministry of Health
Labor and Welfare
MiNK Therapeutics
Miraculins
Miralogx
Mira Pharmaceuticals
Miromatrix Medical
Mitsubishi Tanabe Pharma
Moderna
Modis Therapeutics
Moleculin Biotech
Mologen
Momenta Pharmaceuticals
Monash University
Monopar Therapeutics
Morgan Stanley
MorphoSys
Mount Sinai Health System
MultiCell Immunotherapeutics
Munich Leukemia Laboratory
Mylan Laboratories
Mylan Pharmaceuticals
Myovant Sciences
NanoVibronix
NanoViricides
NantCell
NantKwest
Nantong Jinghua Pharmaceutical
NantWorks
Napo Pharmaceuticals
Natac Biotech
Natco Pharmaceuticals
National Green Biomed
Nektar Therapeutics
Neogenomics
Neotope
Nephrogenex
Nephros
Nestle Health Science
Neuraxpharm
Neurocrine Biosciences
NeuroRx
NeuroSigma
NeuroVive Pharmaceutical
NeuroVive Pharmaceutical Asia
NewLeaf Brands
Newsoara Biopharma
New York University
NexMed
NextCure
Nextleaf Solutions
Nexvet
NGM Biopharmaceuticals
Nicox
Nkarta Therapeutics
NLS Pharmaceutics
Nordic Bioscience
Norgine
NorthStar Medical Radioisotopes
Notable Labs
Novadaq Technologies
NovaDel Pharma
Novan
Novan Therapeutics
Novartis
Novartis Vaccines and Diagnostics
Novocure
Novo Nordisk
Novus Biologicals
NRx Pharmaceuticals
Nucorion
Numab
Nunzi Pharmaceutical
Nurix Therapeutics
Nutech Medical
NutraOrigin
NXTGEN
Nymox Pharmaceutical
Oberland Capital
Ocugen
Oculus Innovative Sciences
Ocumension Therapeutics
Omeros
Oncologie
Oncolytics Biotech
OncoMed Pharmaceuticals
Onconova Therapeutics
Onegevity
One Way Liver Genomics (OWL)
ONK Therapeutics
Ono Pharmaceutical
Onxeo
Onyx Pharmaceuticals
Opexa Therapeutics
Opthea
OptiBiotix
OptiNose
Oragenics
Oramed Pharmaceuticals
Orexigen Therapeutics
Organovo
Orgenesis
Orion
Orox Pharmaceuticals
OrthoCyte
Otsuka
OvaMed
Ovid Therapeutics
Oxford BioMedica
Oxis Biotech
Oxygen Biotherapeutics
OxySure Systems
Oyster Point Pharma
Pan-Provincial Vaccine Enterprise
Parnell Pharmaceuticals
Par Pharmaceutical
PDL BioPharma
PDS Biotechnology
Penwest Pharmaceuticals
Pernix Therapeutics
Perugia University
Pfenex
Pfizer
Pharmacyclics
PharmaCyte Biotech
PharmaMar
PharmaNova
Pharmastrip
Philogen
Phosphagenics
Photocure ASA
Phusion Laboratoies
Phyto Nutricare
Pipex Pharmaceuticals
Plandai Biotechnology
Pluristem Therapeutics
POINT Biopharma
Portola Pharmaceuticals
Poseida Therapeutics
Pozen
PreMD
Premier Biomedical
Professional Compounding Centers of America
Progenics Pharmaceuticals
Prometic Life Sciences
ProQR Therapeutics
Prosidion
Protagonist Therapeutics
Protalix BioTherapeutics
Proteonomix
Prothena
ProtoKinetix
Pulmatrix
Puma Biotechnology
QED Therapeutics
QRxPharma
Quick Med Technologies
Quigley Corporation
Quoin Pharmaceuticals
Rayner Surgical
Reata Pharmaceuticals
Recordati
Recro Pharma
RedHill Biopharma
Reedy Creek Investments
RegenaStem
Regeneron Pharmaceuticals
Regenxbio
Regnum
Relay Therapeutics
Relief Therapeutics
Relmada Therapeutics
RenalytixAI
ReNeuron
Repare Therapeutics
Replicel Life Sciences
Repligen
Reprise Biomedical
Resarci Therapeutics
Retrophin
rEVO Biologics
Revolution Medicines
Rigel Pharmaceuticals
RNL Bio
Roche
Rockefeller University
Roivant Sciences
Royalty Pharma
RST Biomedikal Sanayi
Ruthigen
RXi Pharmaceuticals
S2 Therapeutics
SACCO
Sagard Healthcare Royalty Partners
Sage Therapeutics
Salix Pharmaceuticals
Sam Amer
Sanara MedTech
Sandoz
Sanofi
Sanofi-Aventis
Sanofi-Pasteur
Sanpellegrino Cosmetics
Santarus
Santen Pharmaceutical
Sanuwave Health
SA Pathology
Sapientia Pharmaceuticals
Sarepta Therapeutics
Schrodinger
Scopus BioPharma
Seagen
Seattle Genetics
Seelos Therapeutics
Sekris Biomedical
Senetek
Senior Paradise
Sensory Cloud
Seqirus
Seres Therapeutics
Sermonix Pharmaceutical
Sesen Bio
SevenScore Pharmaceuticals
Shanghai Pharmaceuticals Holdings
Sheba Medical Center
Shenzhen BioScien Pharmaceuticals
Shield Therapeutics
Shionogi
Shire Pharmaceuticals
Shore Therapeutics
Siemens Healthcare Diagnostics
Sigma-Tau
Sinclair Pharmaceuticals
Sinobiopharma
Sinopharm
Sio Gene Therapies
Skinvera
Skyline Diagnostics
Solarvest BioEnergy
Soliance
Soligenix
Sonoma BioTherapeutics
Sorrento Therapeutics
Spectranetics
Spencer Pharmaceutical
Spinal USA
St. Jude Children's Research Hospital
STADA Arzneimittel
Staidson (Beijing) BioPharmaceuticals
Stanford University
Stealth BioTherapeutics
Stellar Biotechnologies
St Jude Medical
Stoke Therapeutics
Strongbridge Biopharma
Sucampo AG
SUDA Pharmaceuticals
Sumitomo Dainippon Pharma
Sunesis Pharmaceuticals
Sunovion Pharmaceuticals
Sun Pharmaceutical
SuperNova Diagnostics
Sutro Biopharma
Swedish Orphan Biovitrum
SymBio Pharmaceuticals
Symbollon
Syndax Pharmaceuticals
Synergy Strips
Syntopix
Tactical Relief
Taiba
TaiGen Biotechnology
Taiho
Takeda Pharmaceutical
Talaris Therapeutics
Tango Therapeutics
Target Group
Tauriga Sciences
TB Alliance
TearLab
Technion Research and Development Foundation
Teijin
Telomir Pharmaceuticals
Tesaro
Tetra Bio-Pharma
TetraLogic Pharmaceuticals
Teva Pharmaceutical Industries
Texas A&M University
Texas Heart Institute
TFF Pharmaceuticals
TG Therapeutics
Therakine
TherapeuticsMD
Theravance
Theravance Biopharma
The Regents of the University of California
Thorne Research
Threshold Pharmaceuticals
TiGenix
Tilray
Titterington Veterinary Services
Tiziana Life Sciences
Tocagen
TONIX Pharmaceuticals
Torii Pharmaceutical
TRACON Pharmaceuticals
Tramorgan
Transgene
Travere Therapeutics
Trellis Bioscience
Trevena
Trimedyne
Trimeris
TrovaGene
TTFactor
Tufts University
Turnstone Biologics
Tyme Technologies
Ultragenyx Pharmaceuticals
Uluru
Unigene Laboratories
UniQure
Universal Cells
University College Dublin
University Health Network
University of Alberta
University of California
University of Central Florida Research Foundation
University of Colorado
University of Florida Research Foundation
University of Geneva
University of Louisville
University of Missouri
University of Notre of Dame
University of Pennsylvania
University of Texas
University of Virginia
University of Western Sydney
University of Zurich
UOP
Uppsalagruppen Medical
Upstream Peripheral Technologies
UroGen Pharma
Valeant Pharmaceuticals
ValiPharma
Valneva
Valor Biotherapeutics
Vanderbilt University
Vasomune Therapeutics
Vaxent
VBL Therapeutics
Veloxis Pharmaceuticals
Veracyte
Verenium
Verity Pharmaceuticals
VeroScience
Vertex Pharmaceuticals
Vida Concepts
Vifor Pharma
ViiV Healthcare
Virbac
Viropharma
VistaGen Therapeutics
Vividion Therapeutics
Vivus
VolitionRX
Voronoi
Voyager Therapeutics
Vyera Pharmaceuticals
VYNE Therapeutics
Vyrix Pharmaceuticals
Watson Pharmaceuticals
WAVE Life Sciences
Wigen Biomedicine
Wisconsin Alumni Research Foundation
World Class Extractions
WPD Pharmaceuticals
WUGEN
Xbrane Bioscience
Xencor
Xlife Sciences
XPhyto Therapeutics
XTL Biopharmaceuticals
Xynomic Pharmaceuticals
Yale University
Yeda Research and Development Company
Yeugnam University
Yissum Research Development
ZAI Laboratory
Zalicus
Zenitech
Zenith Epigenetics
Ziopharm Oncology
Zogenix
ZS Pharma
Zymeworks
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疫苗
2023-08-18
·赛柏蓝
无副作用？防脱、生发赛道新疗法、新靶点涌现，一批国内药企布局。01无副作用？干细胞等新疗法进入生发领域 8月15日，据行业媒体News7Health报道，一家总部位于美国加州的脱发治疗企业More Hair Naturally因其防脱发产品获得「最佳干细胞局部治疗奖」。不同于米诺地尔、非那雄安等传统药物治疗，More Hair Naturally主要利用成体干细胞和肽复合物等治疗脱发，并称“无副作用”，是一种更新的疗法。国家卫健委调查显示，2019年中国脱发人群已经超过2.5亿人，平均每6人中就有1人脱发，其中90%左右为雄激素性脱发，男性患病率约为21.3%，但女性的患病率也有约6.0%。 非那雄胺、米诺地尔、度他雄胺是中国已获批的主要脱发治疗药物。其中，非那雄胺、度他雄胺存在生殖系统等方面副作用；米诺地尔的副作用包括可能出现过敏性皮炎和瘙痒等。 相比于传统药物治疗，More Hair Naturally的干细胞疗法则以“无副作用”为亮点。据介绍，More Hair Naturally的产品主要由三种不同的成体干细胞驱动，以改善毛囊状况，激活头发生长，再加入不同的肽复合物和功能性益生菌，三者共同协同抑制头皮上睾酮向二氢睾酮（DHT）的转化。 DHT也正是导致雄激素性脱发的“元凶”——过高水平的DHT会使毛囊萎缩，缩短头发生长周期，最终形成脱发。 据该企业介绍，其产品中的干细胞来源于成人脂肪，这种间充质干细胞可以分泌肝细胞生长因子（HGF）、胰岛素样生长因子（IGF）和血小板衍生生长因子（PDGF）等多种生长激素。 2020年8月，发布在牛津大学《干细胞转化医学》杂志的一项随机、双盲、赋形剂对照的临床研究结果显示：脂肪来源的干细胞成分提取物（ADSC-CE）有助于雄激素性脱发（AGA）患者的头发再生，在第16周，头发数量增加28.1%，头发直径增加14.2%，且未出现安全性问题。 除More Hair Naturally外，RepliCel Life Sciences的RCH-01、Kimia Farma的Adipose-derived Stem Cell等均是雄脱治疗领域的在研干细胞疗法，且已进入Ⅲ期临床阶段。 这一领域的商业化前景也被部分企业看好。例如，据报道，日本资生堂集团就曾以2870万美元的价格与RepliCel达成合作，购买在亚洲（包括日本）对RCH-01毛发再生技术的使用权。 02大批国内药企布局防脱、生发赛道 观研报告数据显示，2018年至2022年，中国的防脱发产品市场规模由23.32亿元增加至76.36亿元，同时，随着居民消费水平以及对外貌形象重视程度提高，该市场预计于2030年将增长至183.93亿元，并持续扩容。 目前，国内的脱发治疗药物已米诺地尔为主，三生制药的蔓迪、振东制药的达霏欣占据绝大部分市场。其中，蔓迪2022年销售额为8.91亿元，同比增长48.1%；振东制药未公布达霏欣具体的销售额，中康CHM数据显示达霏欣2022年在OTC市场份额占比达到42.34%，销量排名第二。 雄脱治疗的在研产品中，开拓药业的福瑞他恩是研发进度靠前的产品之一。 福瑞他恩是一款外用雄激素受体（AR）拮抗剂，直接作用于头皮的靶向治疗部位。7月19日，开拓药业宣布福瑞他恩（KX-826）在中国启动用于治疗雄脱的长期安全性实验完成首例患者入组；5月11日，福瑞他恩在美国治疗脱发的II期临床试验成功完成；3月28日，福瑞他恩治疗男性脱发中国III期临床试验也已完成全部受试者入组，预计将在今年第四季度公布顶线数据。 此外，嘉兴特科罗生物的TDM-105795、开拓药业的GT-20029、和其瑞从拜耳引进的HMI-115、科笛生物的CU-40101等均是国内雄脱治疗领域进入临床阶段的在研药物。 除了雄性激素脱发，发病率仅次于雄激素性脱发的由T细胞介导的自身免疫性疾病——斑秃，也是各大药企布局相关治疗药物的重点赛道，其竞争同样激烈。 今年6月，恒瑞旗下子公司瑞石生物的艾玛昔替尼成功获NMPA的上市申请受理，虽据推测其此次申报适应症为特应性皮炎，但其此前已在治疗成人斑秃的Ⅱ期临床中取得积极结果，作为首个国产新一代JAK1抑制剂，若其顺利上市，也将是国产斑秃新药研发的重要进展。 泽璟制药的盐酸杰克替尼片也正处于治疗重症斑秃的III期临床试验中，据泽璟制药8月在调研问答中的回复，除盐酸杰克替尼片外，其盐酸杰克替尼乳膏在开展治疗轻中度斑秃（外用）和轻中度特应性皮炎（外用）适应症的临床研究，均处于I/II期临床试验阶段。 另外，科伦博泰的JAK1/2抑制剂KL130008胶囊已在中国开展4项临床试验，包括用于重度斑秃患者的治疗；启元生物的JAK1/TYK2抑制剂QY201也已在中国获批开展针对斑秃、银屑病、特应性皮炎等的临床试验。END作者 | 陈芋来源 | 赛柏蓝扫描下方二维码，进入赛柏蓝药械交流群更多行业资讯，欢迎交流~
临床3期细胞疗法临床结果ASH会议
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