Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) ± Rituximab + Recombinant Erwinia Asparaginase (JZP458; Rylaze®) for the Treatment of Newly-Diagnosed Adults With Philadelphia Chromosome-Negative Acute Lymphoblastic Lymphoma/Leukemia

This phase II trial tests how well etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin (DA-EPOCH) with or without rituximab plus recombinant Erwinia asparaginase (JZP458) works in treating patients with newly diagnosed Philadelphia chromosome (Ph) negative B-acute lymphoblastic leukemia (ALL) or T-ALL. Chemotherapy drugs, such as etoposide, vincristine, cyclophosphamide and doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. JZP458 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving DA-EPOCH with or without rituximab plus JZP458 may kill more cancer cells in patients with newly diagnosed Ph negative B-ALL or T-ALL.

开始日期2025-06-01

申办/合作机构

University of Washington

[+1]

NCT06528691

/ Recruiting临床2期IIT

PHASE 2 Study of Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors (GLOBOTRK)

This clinical trial tests how well entrectinib works to treat patients less than 3 years of age with NTRK 1/2/3 or ROS1 fused, high grade glioma or other central nervous system (CNS) tumors.

开始日期2025-02-01

申办/合作机构

St. Jude Children's Research Hospital, Inc.

[+1]

NCT06616987

/ Not yet recruiting临床2期IIT

A Multicenter, Open-label, Single-arm, Phase II Clinical Trial to Evaluate the Preventive Effect of Pegylated G-CSF (PG) on Neutropenia in Patients With Metastatic Triple-negative Breast Cancer (mTNBC) Receiving Sacituzumab Govitecan (SG)

Prevention of Sacituzumab Govitecan-related Neutropenia in Patients with metastatic Triple Nagative Breast Cancer who have received at least one, and no more than two, prior standard of care chemotherapy regimens

开始日期2025-01-31

申办/合作机构

Samsung Medical Center

100 项与培非格司亭（安进）相关的临床结果

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100 项与培非格司亭（安进）相关的转化医学

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100 项与培非格司亭（安进）相关的专利（医药）

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116

项与培非格司亭（安进）相关的文献（医药）

2025-01-02·INTERNATIONAL JOURNAL OF RADIATION BIOLOGY

IEPA, a novel radiation countermeasure, alleviates acute radiation syndrome in rodents

Article

作者: Eibl, Michael ; Czajkowski, Maciej T. ; Pleimes, Dirk ; Singh, Nikita ; Orschell, Christie M. ; Bähr, Stella ; Himburg, Heather A. ; Gasperetti, Tracy ; Fish, Brian L. ; Munjal Mehta, Srishti ; Asang, Corinna ; Wesolowski, Radoslaw

Repurposing therapeutic agents with existing clinical data is a common strategy for developing radiation countermeasures. IEPA (imidazolyl ethanamide pentandioic acid) is an orally bioavailable small molecule pseudopeptide with myeloprotective properties, a good clinical safety profile, and stable chemical characteristics facilitating stockpiling. Here, we evaluated IEPA's radiomitigative efficacy in the hematopoietic subsyndrome of acute radiation syndrome (H-ARS) using total-body irradiation (TBI) models in C57BL/6J mice and WAG/RijCmcr rats, applying various posology schemes and introducing syringe feeding of the IEPA formulation in the pudding. Additionally, we assessed IEPA in the delayed effects of acute radiation exposure (DEARE) model after partial-body irradiation (PBI) in WAG/RijCmcr rats. Endpoints included survival, body weight, hematology, and pulmonary parameters, depending on the model. Results from mouse and rat TBI models demonstrated survival improvements with repeated IEPA dosing at 10 mg/kg, with the largest benefits observed in the bi-daily (BID) treatment over the 30-day ARS phase in female rats. Survival across PBI-DEARE subsyndromes was comparable between IEPA and vehicle groups, though IEPA improved pulmonary parameters in female rats during the lung-DEARE phase. Sex-related differences in response to irradiation and IEPA were noted, with females showing a survival advantage. IEPA treatment is compatible with Neulasta® (Pegfilgrastim; PEG-G-CSF); adequately powered studies are needed to confirm the trend toward improved survival over standard care alone. IEPA is a promising development candidate as a medical countermeasure against the effects of acute radiation syndrome. Further confirmatory studies in small and large animal models should validate the robustness and translatability of preliminary rodent data on IEPA's radiomitigative efficacy.

2024-06-04·LANGMUIR

pH- and Photoresponsive Liquid Plasticine

Article

作者: Harun-Or-Rashid, Md ; Yusa, Shin-Ichi ; Fujii, Syuji ; Onodera, Ema ; Usuda, Sari ; Nakamura, Yoshinobu ; Hara, Hodaka

Liquid marbles (LMs) can be prepared by adsorption of hydrophobic particles at the air-liquid interface of a water droplet. LMs have been studied for their application as microreaction vessels. However, their opaqueness poses challenges for internal observation. Liquid plasticines (LPs), akin to LMs, can be prepared by the adsorption of hydrophobic particles with a diameter of 50 nm or less, at the air-liquid interface of a water droplet. Unlike LMs, LPs are transparent, allowing for internal observation, thus presenting promising applications as reactors and culture vessels on a microliter scale. In this study, the surface of silica particles, approximately 20 nm in diameter, was rendered hydrophobic to prepare hydrophobic silica particles (SD₀). A small amount of poly(2-(diisopropylamino)ethyl methacrylate) (PDPA) was then grafted onto the surface of SD₀, yielding SD₁. SD₀ particles exhibited consistent hydrophobicity irrespective of the environmental pH atmosphere. Under acidic conditions, SD₁ became hydrophilic due to the protonation of pendant tertiary amines in the grafted PDPA chains. However, SD₁ alone was unsuitable for LP preparation due to its high surface wettability regardless of atmospheric pH, attributable to the presence of PDPA-grafted chains. Therefore, to prepare pH-responsive LP, SD₁ and SD₀ were mixed (SD₁/SD₀ = 3/7). Upon exposure to HCl gas, these LPs ruptured, with the leaked water from the LPs being absorbed by adjacent paper. Moreover, clear LPs, prepared using an aqueous solution containing a water-soluble photoacid generator (PAG), disintegrated upon exposure to light as PAG generated acid, leading to LP breakdown. In summary, pH-responsive LPs, capable of disintegration under acidic conditions and upon light irradiation, were successfully prepared in this study.

2024-06-01·DRUGS IN R&D

Demonstration of Physicochemical and Functional Similarity of Biosimilar Pegfilgrastim-cbqv to Pegfilgrastim

Article

作者: Davis, Janice M ; Valentine, Elizabeth ; Merewether, LeeAnne ; Andrews, Benjamin T ; McQueen, Matthew ; Miller, Karen J ; Young, Glen ; Diaz, Dimitri ; Kuehne, Henriette

BACKGROUND:

Pegfilgrastim-cbqv/CHS-1701 (UDENYCA^®) (hereafter referred to as pegfilgrastim-cbqv) was approved in 2018 by the US Food and Drug Administration as a biosimilar for pegfilgrastim (Neulasta^®) (hereafter referred to as pegfilgrastim). Both pegfilgrastim-cbqv and pegfilgrastim are conjugates of recombinant human granulocyte colony stimulating factor (r-metHuG-CSF) with a 20 kDa polyethylene glycol (PEG) indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients receiving myelosuppressive anticancer drugs. The demonstration of analytical similarity for PEG-protein conjugates presents unique challenges since both the protein and PEG attributes must be characterized.

OBJECTIVE:

The current study demonstrates the analytical similarity of pegfilgrastim-cbqv and the reference product, pegfilgrastim. In addition to the physicochemical and functional characterization of the protein, the study assessed attributes specific to PEGylation including PEG size and polydispersity, site of attachment, linker composition, and PEGylation process-related variants.

METHODS:

The structural, functional, and stability attributes of pegfilgrastim-cbqv and pegfilgrastim were compared using state-of-the-art analytical methods. For the protein, the primary structure, disulfide structure, and secondary and tertiary structures were assessed using traditional protein characterization techniques such as mass spectrometry (MS), circular dichroism (CD), intrinsic fluorescence, and differential scanning calorimetry (DSC), as well as more advanced techniques such as two-dimensional (2D) nuclear magnetic resonance (NMR) and hydrogen deuterium exchange (HDX). For the PEG moiety, the site of attachment, occupancy, linker composition, size and polydispersity were compared using mass spectrometry (both intact and after endoprotease digestion), multiangle light scattering detection (MALS), and Edman degradation. Purity assessments included the assessment of both protein variants and PEGylation variants using chromatographic and electrophoretic analytical separation techniques. The functional similarity between pegfilgrastim-cbqv and pegfilgrastim was compared using both a cell-based bioassay and surface plasmon resonance (SPR). The degradation rates and stability profiles were compared under accelerated and stressed conditions.

RESULTS:

Biosimilarity was demonstrated by a thorough assessment of physiochemical and functional attributes, as well as comparative stability, of pegfilgrastim-cbqv relative to pegfilgrastim. These studies demonstrated identical primary structure and disulfide structure, highly similar secondary and tertiary structure, as well as functional similarity. The impurity profile of pegfilgrastim-cbqv was comparable to that of pegfilgrastim with only minor differences in PEGylation variants and a slight offset in the PEG molar mass. These differences were not clinically relevant. The degradation profiles were qualitatively and quantitatively similar under accelerated and stress conditions.

CONCLUSION:

The structural, functional, and stability data demonstrate that pegfilgrastim-cbqv is highly similar to the reference product, pegfilgrastim.

189

项与培非格司亭（安进）相关的新闻（医药）

2024-12-18

·GlobeNewswire-Health Care

Akari Therapeutics Announces Key Leadership Appointments

Samir R. Patel, M.D., appointed as Chief Executive Officer Abizer Gaslightwala appointed to Board of Directors BOSTON and LONDON, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX) today announced the appointment of Samir R. Patel, M.D., as Chief Executive Officer, effective December 16, 2024. Dr. Patel has served as interim Chief Executive Officer since May 2024. Additionally, the Company announced it has appointed Abizer Gaslightwala to its Board of Directors, effective December 16, 2024. Michael Grissinger, a member of the Board of Directors, provided notice of his resignation on December 16, 2024. “Since beginning my role as interim CEO in May 2024, we have worked diligently to close the merger with Peak Bio, which we accomplished in November, and position Akari for continued growth and value creation. Looking ahead, we are focusing our efforts and resources to streamline operations and execute on our portfolio prioritization – our potentially best-in-class ADC platform. I am pleased to solidify my role with the Akari team and look forward to building momentum and driving shareholder value in the near and long term,” commented Dr. Patel, Chief Executive Officer of Akari. About Samir R. Patel, M.D. Dr. Patel currently serves as founder and principal of PranaBio Investments, LLC, a firm providing consulting, strategic advisory, and investment services for small cap biotechnology companies. He is also a consultant to GE Global Research, GE’s innovation engine that is creating novel products and solutions across several sectors including biomanufacturing and biotechnology. He has more than 20 years of experience in life sciences including founding SPEC Pharma, LLC, a company that develops and manufactures injectables used in human and veterinary applications. Previously, Dr. Patel held multiple roles in Medical Affairs with Centocor, Inc. (now Johnson & Johnson Innovative Medicine, part of Johnson & Johnson). He holds multiple patents, has been an author on several publications and has been an investigator in numerous clinical research studies. He has served on the boards of several public companies, including Rezolute Bio. Dr. Patel received his medical degree from the Medical College of Ohio and completed his internal medicine internship, residency, and rheumatology fellowship at The University of New Mexico School of Medicine Affiliated Hospitals. About Abizer Gaslightwala Mr. Gaslightwala is a well-established biotechnology / pharmaceutical industry leader with a demonstrated track record of success spanning over 25 years in the development and commercialization of novel medicines across a range of companies and therapeutic areas. Mr. Gaslightwala currently serves as the Senior Vice President and Franchise Head for Oncology at Jazz Pharmaceuticals, where he has full responsibility for a portfolio of products spanning both solid and hematological malignancies that have total annual sales of $1B. These brands include ZIIHERA® for HER2+ cancers, ZEPZELCA® for small cell lung cancer, and RYLAZE®, DEFITELIO®, and VYXEOS® for a range of hematological malignancies. “We are pleased to welcome Abizer to our Board of Directors. We believe the depth and breadth of his development and commercialization leadership and expertise amassed over the course of his career will provide valuable insight as we work to propel Akari to its next phase of growth. Additionally, we would like to thank Michael for his years of service on our board. His perspective and guidance have played a key role in getting the Company to where we are today,” added Dr. Patel. Mr. Gaslightwala added, “I'm thrilled to join the Akari board and have been extremely compelled by the Company’s unique ADC platform targeting the spliceosome, that has the potential to set a new standard of care for cancer patients. I look forward to working closely with the management team and other members of the board to advance this platform forward and potentially address areas of significant unmet need for cancer patients.” Prior to his current position at Jazz Pharmaceuticals, Mr. Gaslightwala has led and driven growth in several leadership roles at Amgen, Pfizer, and Johnson & Johnson across multiple brands including Kyprolis®, Vectibix®, Neulasta®, XGEVAf®, Repatha®, and ELIQUIS®. His experience spans business unit leadership, brand marketing, sales leadership, commercial pipeline planning, advanced analytics and insights, and business development. Mr. Gaslightwala also helped lead R&D strategic planning within the autoimmune/inflammation portfolio at Johnson & Johnson, as well as lead commercial planning for Remicade® and several novel pipeline molecules focused on rheumatoid arthritis, inflammatory bowel disease, psoriasis, and atopic dermatitis. Additionally, Mr. Gaslightwala advised several life science companies through his time at the Boston Consulting Group (BCG). Mr. Gaslightwala holds a BS in Chemical Engineering from Cornell University, and an MBA from the Sloan School of Management, and a MS in Chemical Engineering from MIT. About Akari Therapeutics Akari Therapeutics, Plc (Nasdaq: AKTX) is a biotechnology company developing advanced therapies for autoimmune, oncology and inflammatory diseases. Akari has two lead assets, investigational nomacopan and an antibody drug conjugate (ADC) platform. Nomacopan is a bispecific recombinant inhibitor of complement C5 activation and leukotriene B4 (LTB4) activity. The Company’s ADC platform includes novel toxins and linkers coupled with important cancer antibody targets. For more information about Akari, please visit akaritx.com. Cautionary Note Regarding Forward-Looking Statements This press release includes express or implied forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), about the Company that involve risks and uncertainties relating to future events and the future performance of the Company. Actual events or results may differ materially from these forward-looking statements. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity” “will likely result,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding: the business combination and related matters, including, but not limited to, post-closing operations and the outlook for the Company’s business; the Company’s targets, plans, objectives or goals for future operations, including those related to its product candidates; financial projections; future economic performance,; and the assumptions underlying or relating to such statements. These statements are based on the Company’s current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. A number of important factors, including those described in this communication, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: the risk that Akari and Peak Bio may not realize the anticipated benefits of the Merger in the time frame expected, or at all; the ability to retain and hire key personnel; potential adverse reactions or changes to business relationships resulting from the Merger; the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, synergies, economic performance, indebtedness, financial condition and losses on the future prospects, business and management strategies for the management, expansion and growth of the combined business; uncertainties as to the long-term value of Akari’s American Depositary Shares (and the ordinary shares represented thereby), including the dilution caused by Akari’s issuance of additional American Depositary Shares (and the ordinary shares represented thereby) in connection with the Merger; risks related to global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations; potential delays or failures related to research and/or development of the Company’s programs or product candidates; risks related to any loss of the Company’s patents or other intellectual property rights; any interruptions of the supply chain for raw materials or manufacturing for the Company’s product candidates, the nature, timing, cost and possible success and therapeutic applications of product candidates being developed by the Company and/or its collaborators or licensees; the extent to which the results from the research and development programs conducted by the Company, and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; uncertainty of the utilization, market acceptance, and commercial success of the Company’s product candidates; unexpected breaches or terminations with respect to the Company’s material contracts or arrangements; risks related to competition for the Company’s product candidates; the Company’s ability to successfully develop or commercialize its product candidates; potential exposure to legal proceedings and investigations; risks related to changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing, development or commercialization of any of the Company’s product candidates; the Company’s ability to maintain listing of its ADSs on the Nasdaq Capital Market. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the SEC, copies of which may be obtained from the SEC's website at www.sec.gov. The Company assumes no, and hereby disclaims any, obligation to update the forward-looking statements contained in this press release. Investor Contact: JTC Team, LLCJenene Thomas908.824.0775AKTX@jtcir.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/110aebf9-2683-41c9-ba9d-bf06f7e42054

高管变更

2024-12-18

·GlobeNewswire-Health Care

Coherus to Present Final Phase 2 Casdozokitug Combination Data in Patients with Metastatic Hepatocellular Carcinoma at ASCO-GI 2025

- Randomized Phase 2 study initiated evaluating the combination of casdozokitug, toripalimab and bevacizumab in patients with liver cancer - REDWOOD CITY, Calif., Dec. 18, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus,” NASDAQ: CHRS) today announced that an abstract highlighting final clinical and biomarker data from its Phase 2 clinical trial evaluating casdozokitug (casdozo), a selective and potent IL-27-antagonistic antibody, in combination with atezolizumab (atezo) and bevacizumab (bev) in treatment naïve patients with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC), has been selected for a poster presentation at the upcoming 2025 ASCO GI Annual Meeting, being held January 23-25, 2025, in San Fransisco, CA. “Casdozo is a first-in-class antibody, and in oncology, is the first IL-27 cytokine antagonist to demonstrate monotherapy responses and immune activation with a safety profile that lends itself to combination,” said Rosh Dias, M.D., Coherus’ Chief Medical Officer. “We look forward to sharing the final data from this Phase 2 combination study of casdozo with standard of care with the medical community at the upcoming 2025 ASCO-GI annual meeting. We now have data across several tumor types for casdozo demonstrating clinical activity. We are particularly excited about HCC given the strong preclinical package for targeting IL-27 in liver cancer and now translation to the clinic.” Coherus has initiated a new randomized Phase 2 study (NCT06679985) evaluating casdozo, in combination with bevacizumab and toripalimab, Coherus’ next-generation anti-PD-1 monoclonal antibody, in participants with first-line HCC. This randomized, parallel, open-label Phase 2 study is designed to evaluate the safety, efficacy, and Project Optimus1 dosing of the triplet combination. The study is expected to enroll up to 72 patients, who will be randomized to receive one of two biologically active doses of casdozo with toripalimab plus bevacizumab or toripalimab plus bevacizumab without casdozo. “Advancing casdozo development in first-line HCC with a randomized Phase 2 combination study marks a significant milestone in our strategic path to progress our clinical pipeline, which is focused on overcoming immune suppression in the tumor microenvironment to extend survival and improve outcomes for patients and pursuing new indications for toripalimab in the U.S.,” continued Dr. Dias. “Casdozo has shown encouraging responses in the first line setting when added to the existing standard of care, atezolizumab and bevacizumab, and we’re excited to build upon these data with this new Phase 2 study evaluating casdozo in combination with toripalimab and bevacizumab.” In the Phase 3 HEPATORCH study, conducted by Junshi Biosciences, patients with advanced HCC treated with toripalimab combined with bevacizumab as a first-line therapy showed significantly better clinical efficacy than sorafenib monotherapy.2 HEPATORCH patients showed an objective response rate of 25.3% versus 6.1% in the sorafenib group, a median progression-free survival of 5.8 months, and a median overall survival of 20 months, compared to 4 and 14.5 months, respectively, for the sorafenib group.3 Toripalimab in combination with bevacizumab was well tolerated, with a toxicity profile consistent with the known toxicity profile of each monotherapy, with no new safety signals identified.3 The results of the HEPATORCH study support the clinical study of toripalimab in combination with bevacizumab as a new first-line treatment option for advanced HCC which, along with the results from the Phase 2 casdozo study reported to date, support pursuing a triple combination of casdozo with toripalimab plus bevacizumab in patients with advanced or metastatic HCC. ASCO-GI 2025 Presentation Details Title: Results from a phase 2 study of triplet blockade of the IL-27, PD-(L)1, and VEGF pathways with casdozokitug (casdozo, CHS-388) in combination with atezolizumab and bevacizumab in patients with unresectable, locally advanced or metastatic hepatocellular carcinoma (uHCC) Lead Author: Daneng Li, City of Hope National Comprehensive Cancer CenterAbstract #: 605Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary TractDate and Time: Friday, January 24, 2025; 11:30 a.m. – 1:00 p.m. PT Hepatobiliary cancers include a spectrum of invasive carcinomas arising in the liver (hepatocellular carcinoma; HCC), gall bladder, and bile ducts (collectively called biliary tract cancers). The most common type of primary liver cancer in adults is HCC (accounting for ~90%), which is the third leading cause of cancer-related deaths worldwide. According to the NCI Surveillance, Epidemiology and End Results Program (SEER), there will be an estimated 41,630 new cases and 29,840 deaths from liver and intrahepatic bile duct cancer in the US in 2024.4 The U.S. 5-year relative survival rate for liver and intrahepatic bile duct cancer is 21.7%.4 The liver cancer treatment pattern has changed in recent years with the emergence of immunotherapy combinations and will continue to evolve as more treatment options become available for these highly lethal cancers. About Coherus BioSciences Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline that is expected to be synergistic with toripalimab and its proven commercial capabilities in oncology. Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust antitumor immunologic response and enhance outcomes for patients with cancer, particularly patients underserved by current immunotherapy treatments. Casdozokitug is a novel IL-27 antagonistic antibody being evaluated in two ongoing clinical studies: a Phase 1/2 study in advanced solid tumors and a Phase 2 study in hepatocellular carcinoma. CHS-114 is a highly selective, competitively positioned, cytolytic anti-CCR8 antibody currently in a Phase 1 study in patients with advanced solid tumors, including HNSCC. CHS-1000 is a novel humanized Fc-modified IgG1 monoclonal antibody specifically targeting ILT4 (LILRB2). An IND for CHS-1000 was allowed to proceed by the FDA in the second quarter of 2024 and proceeding to the first-in-human clinical study is subject to further evaluation in our portfolio prioritization process. Coherus markets LOQTORZI® (toripalimab-tpzi), a novel next-generation PD-1 inhibitor, and UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta. In December 2024, Coherus announced that it entered into an agreement for the divestiture of the UDENYCA franchise. The proposed transaction is expected to close by the end of the first quarter of 2025. Neulasta® is a registered trademark of Amgen, Inc. Forward-Looking Statements Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Coherus’ expectations about identifying synergies between its I-O pipeline and its commercial operations and its I-O pipeline and toripalimab; future enrollment estimates for Coherus’ clinical studies; Coherus’ expectations that it will be able to demonstrate that its clinical pipeline candidates can extend patient survival; and the ability to satisfy the closing conditions to consummate the proposed transaction for the divestiture of the UDENYCA franchise at all or in the estimated time. Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; risks related to Coherus’ existing and potential collaboration partners; risks of Coherus’ reliance on third-parties; the risks and uncertainties related to manufacturing and supply of Coherus’ products, the risks and uncertainties of the regulatory approval process, including the speed of regulatory review and the timing of Coherus’ regulatory filings; uncertainties as to the timing for completion of the proposed transaction; uncertainties as to the Company’s ability to obtain the approval of its shareholders required to consummate the proposed transaction for the divestiture of UDENYCA; the possibility that competing offers will be made by third parties; the occurrence of any event, change or other circumstance that may give rise to a right of one or both parties to terminate the agreement to divest UDENYCA; the possibility that the proposed transaction for the divestiture of UDENYCA may not be completed in the time frame expected by the Company or at all, including due to the possibility that a governmental entity may prohibit, delay, or refuse to grant approval, if required, for the consummation of the proposed transaction to divest UDENYCA (or only grant approval subject to adverse conditions or limitations). All forward-looking statements contained in this press release speak only as of the date of this press release. Unless required by law, the Company is not under any duty and undertakes no obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, of new information, data or methods, future events or other changes. For a further description of the significant risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2024 filed with the Securities and Exchange Commission on November 6, 2024, including the section therein captioned “Risk Factors” and in other documents Coherus files with the Securities and Exchange Commission including, when available, the proxy statement of the Company relating to the proposed transaction for the divestiture of UDENYCA. UDENYCA® and LOQTORZI®, whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies or its licensors or joint venture partners unless otherwise noted. Trademarks and trade names of other companies appearing in this press release are, to the knowledge of Coherus, the property of their respective owners. Coherus Contact Information:For Investors:Jodi SieversVP, Investor Relations & Corporate CommunicationsIR@coherus.com For Media:Argot Partners(212) 600-1902coherus@argotpartners.com 1Project Optimus: Reforming the dose optimization and dose selection paradigm in oncology 2Shanghai Junshi Biosciences Co., Ltd (2024, June 11) Junshi Biosciences Announces Phase 3 Study of Toripalimab Combined with Bevacizumab for the First-line Treatment of Advanced Hepatocellular Carcinoma Meets Primary Endpoint 3FAN, J. (2024) HEPATORCH: A randomized, open-label, multicenter, phase III clinical study of the safety and efficacy of toripalimab combined with bevacizumab versus sorafenib as first-line treatment for advanced hepatocellular carcinoma presented at the 2024 Annual Meeting of Chinese Society of Clinical Oncology 4National Cancer Institute Cancer Stat Facts: Liver and Intrahepatic Bile Duct Cancer; retrieved December 17, 2024, from https://seer.cancer.gov/statfacts/html/livibd.html

临床2期临床结果免疫疗法临床3期ASCO会议

2024-12-10

·医药健闻

药明康德2000万欧元出资法国医疗投资机构；恒瑞医药拟在港交所主板上市；诺和165亿美元收购案获欧盟无条件批准 | 日报

全球医疗行业每日重点资讯文 | 苏丁企业动态罗氏（Roche）宣布将投资超过6亿欧元，在德国建立一座高科技生产中心。此举标志着罗氏在德国历史上规模最大的单笔投资。超过 450 种用于IVD试剂的原材料，将在高度自动化和数字化的生产基地生产。该中心计划于 2028 年投入运营。从 2019 年到 2023 年，罗氏已经在其德国工厂投资了约 30 亿欧元（约230亿人民币）。诺和诺德（Novo Nordisk）为扩大其全球制造能力而进行了数年数十亿美元的大举投资，目前正在其位于丹麦的老根据地奠定新的基础，以加强生产的一个关键组成部分：质量控制。诺和诺德将投资29亿丹麦克朗（约合4.09亿美元），在丹麦Hillerød新建一个占地5.3万平方米的质量控制实验室，该公司还在那里运营一家庞大的工厂，专注于生产治疗糖尿病和肥胖症等慢性疾病的注射笔。该实验室已经开始建设，并计划在2027年完成该项目。这笔支出是该公司迄今为止在先进质量控制方面的最大投资。欧盟委员会无条件批准诺和诺德大股东诺和控股（Novo Holdings）收购生物制药合同制造商康泰伦特的交易，定该交易不会在欧洲经济区引发竞争问题。诺和控股今年2月宣布，将以全现金交易形式收购康泰伦特，加上债务的企业总价值达到165亿美元。作为交易的一部分，诺和诺德将以110亿美元的预付款从诺和控股手中收购康泰伦特位于意大利阿纳尼、比利时布鲁塞尔和美国印第安纳州布卢明顿的三座灌装工厂，这三座工厂拥有超3000名员工。安进（Amgen）斥资10亿美元在北卡罗来纳州的霍利斯普林斯（Holly Springs）建造第二家药品工厂。继之前投资5.5亿美元之后，最新项目使安进在该地区的总计划投资超过15亿美元。该工厂将结合当前的技术和可持续的做法。加上安进现有的工厂，该公司在霍利斯普林斯的投资预计将创造370个新工作岗位。骨科器械巨头施乐辉(Smith & Nephew)宣布，将在美国田纳西州进行裁员，涉及150个岗位。施乐辉一位发言人通过电子邮件表示：“施乐辉公司正致力于转型为更高效、更有效、更灵活的企业。在孟菲斯，随着我们不断提高业务效率，发现有些活动已不再需要以当前的形式进行。”“不幸的是，这意味着我们将裁减约150个岗位。” 礼来公司周一表示，董事会批准一项高达150亿美元股票回购的计划，以反映重磅减肥药Zepbound对公司增长的推动力。同时，公司将季度股息提高15%。恒瑞医药拟在境外发行股份（H股）并在香港联合交易所有限公司主板上市，以深入推动科技创新和国际化双轮驱动战略，进一步助力公司国际化业务的发展。公司聘请安永会计师事务所为公司发行H股股票并在香港联合交易所有限公司主板上市的审计机构。广州银诺医药集团股份有限公司递交港交所上市申请。银诺医药成立于2014年，致力于研究及开发治疗糖尿病和其他代谢性疾病的创新疗法，目前是亚洲第一家、全球第三家将原研人源长效GLP-1受体激动剂推进到注册审批阶段的公司。苏州齐禾生科生物科技有限公司完成超2亿元人民币A轮融资。本次融资由北京市医药健康产业投资基金领投，昌发展集团、铭哲资产、辰德资本参与跟投。高榕创投2023年参与齐禾生科超亿元Pre-A轮融资。所筹资金将主要用于公司基因编辑技术的深度研发、基因编辑产品管线的优化与拓展，以及商业化平台落地。新华制药与挪亚欧洲公司签订《股权收购意向协议》，拟通过现金方式受让挪亚欧洲公司持有的挪亚圣诺不超过75%股权。收购完成后，公司将成为目标公司的控股股东，目标公司将纳入本公司合并报表范围。挪亚圣诺与新华制药鱼油产业具有高度互补性和协同性，本次股权收购符合本公司在大健康板块的战略规划与布局。产业动态药明康德旗下全资子公司与JeitoCapital S.A.S.签署认购协议，认缴Jeito II S.L.P.投资基金2000万欧元（约合人民币1.525亿元）的A类份额。Jeito Capital是一家总部位于法国，重点投向欧洲生物制药公司，投资的治疗领域包括免疫肿瘤学、眼科、罕见骨骼疾病、严重呼吸系统疾病、纤维化及相关癌症。此次药明康德拟投资的“Jeito II S.L.P.”是其新一期基金，目标总规模不超过12亿欧元，已募集约3.87亿欧元。基金预计将投资14-17家医疗创新初创企业。美国当地时间2024年12月7日，美国国会参众两院军事委员会公布了2025财年国防授权法案（NDAA）最终协议文本，生物安全法案未被列入其中。今年以来，美国生物安全法案的立法进程，多次惊扰资本市场，该法案拟限制美国联邦政府与中国部分生物技术提供商开展业务往来。诺泰生物与美国斯普瑞喷雾系统公司签署《战略合作意向书》，双方将合作推进静电喷雾干燥技术在多肽原料药商业化生产领域的应用。此项合作旨在提升生产效率，降低成本，并计划于2027年底前完成约16台设备的供货。通过此次合作，诺泰生物期望巩固其在多肽大规模生产领域的市场优势，推动实现年产数十吨及以上的生产目标。在2024年初将其几种胰岛素产品的美国价格下调75%后，诺和诺德在年底宣布将其大多数其他胰岛素产品降价。诺和诺德分别将其Fiasp和Tresiba的美国标价下调75%和72%。新价格将于2026年1月1日生效。前者供患者在进餐时服用，后者则为每天注射。与降价相关，诺和诺德还补充，到2025年底，它将停止销售其几种胰岛素产品的无品牌生物制剂。 Coherus BioSciences已同意以高达5.584亿美元的价格将其生物仿制药Udenyca（参考安进的发热性中性粒细胞减少药物Neulasta）出售给Intas Pharmaceuticals。Coherus为Udenyca配备了三种给药方式：预充注射器（PFS）、自动注射器（AI）和可穿戴注射装置（OBI）。这笔交易预计将于2025年第一季度末完成，届时Coherus将获4.834亿美元的预付款，外加7500万美元的潜在销售里程碑。天境生物与济川药业联合宣布，伊坦长效重组人生长激素注射液治疗儿童生长激素缺乏症（PGHD）的生物制品上市申请（BLA）已获NMPA受理。伊坦长效生长激素采用创新的hyFc融合蛋白技术，通过将人生长激素与特殊设计的人免疫球蛋白相结合，大大提升了药物的稳定性和半衰期。伊坦成为首款每周一次给药的融合蛋白长效生长激素。绿叶医疗集团与深圳市卫生健康委签署战略合作协议，计划在深圳建设国际医疗总部和外商独资专科医院。这将是国家四部门《独资医院领域扩大开放试点工作方案》公布后，全国首个落地的外商独资专科医院项目。绿叶医疗集团是绿叶生命科学集团旗下的医疗服务板块，1997年成立于新加坡，在澳大利亚、新加坡、中国均有业务布局。康哲药业创新药莱芙兰（亚甲蓝肠溶缓释片）于近日开出全国首批处方，标志着中国首个口服亚甲蓝肠溶缓释片正式进入临床应用。产品用于在接受结肠镜检查筛查或监测的成人患者中增强结直肠病变的可视化。至此，康哲药业5款创新药已成功在中国获批，并全面进入临床应用。东软医疗携10余款AI驱动的创新产品与解决方案第25次亮相百年放射学盛会RSNA。同期，公司与知名医院联合中稿的14篇论文登场。东软医疗全方位展示了AI智能影像的最新成果，率先勾画出了AI影像三个重要场景：AI优化设备扫描流程、AI辅助影像诊断以及AI辅助治疗规划，进而形成了AI在医学影像诊疗全流程的覆盖。诺纳生物宣布与Kodiak Sciences lnc.达成合作。此次合作将利用诺纳生物专有的Harbour Mice全人源抗体技术平台，推进治疗眼科疾病的多靶点新型抗体疗法的研发。根据合作协议，Kodiak Sciences将有权使用H2L2 Harbour Mice和HCAb Harbour Mice技术平台，进行多个治疗性抗体项目的开发。韩国首尔国立大学盆唐医院（SNUBH）、CurePSP, Inc.和GemVax & KAEL Co., Ltd.联合宣布成立韩国首个国际进行性核上性麻痹（PSP）研究与治疗中心。旨在共同建立一个综合性中心，推进对PSP和其他神经系统疾病以及与成瘾相关的各种疾病的研究和治疗。中心将整合三方的基础设施和专业知识，以执行一系列综合职能，包括教育、研究和治疗，以及PSP和其他神经系统疾病疗法的潜在商业化。联系美通社 +86-10-5953 9500 info@prnasia.com

并购

100 项与培非格司亭（安进）相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06889	培非格司亭（安进）	L03AA13	DB00019

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
造血干细胞移植	日本	Kyowa Kirin Co., Ltd.	2024-05-17
干细胞动员	日本	Kyowa Kirin Co., Ltd.	2022-02-25
中性粒细胞减少	欧盟	Amgen Europe BV	2002-08-22
中性粒细胞减少	冰岛	Amgen Europe BV	2002-08-22
中性粒细胞减少	列支敦士登	Amgen Europe BV	2002-08-22
中性粒细胞减少	挪威	Amgen Europe BV	2002-08-22
粒细胞减少性发热	美国	Amgen, Inc.	2002-01-31
感染	美国	Amgen, Inc.	2002-01-31

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
1型糖尿病	临床2期	美国	Amgen, Inc.	2014-12-01
乳腺癌	临床2期	美国	Amgen, Inc.	2013-01-17
骨痛	临床2期	美国	Amgen, Inc.	2013-01-17
肿瘤	临床2期	法国	Amgen, Inc.	2008-09-12
多发性骨髓瘤	临床2期	法国	Amgen, Inc.	2008-09-01
复发性卵巢癌	临床2期	-	Amgen, Inc.	2003-10-01
霍奇金淋巴瘤	临床2期	-	Amgen, Inc.	2003-04-01
非霍奇金淋巴瘤	临床2期	-	Amgen, Inc.	2003-04-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASCO_GU2024 人工标引	N/A	生殖细胞和胚胎肿瘤	196	bleomycin+Pegfilgrastim	願獵願鏇獵簾遞壓簾繭(鹽積壓壓鏇鹽簾憲齋壓) = 廠糧積淵願選夢蓋選簾糧鬱構憲憲獵鬱壓願壓 (築範襯夢鬱鏇膚網膚網 ) 更多	积极	2024-01-25
				bleomycin	願獵願鏇獵簾遞壓簾繭(鹽積壓壓鏇鹽簾憲齋壓) = 選淵獵醖網繭糧遞壓窪糧鬱構憲憲獵鬱壓願壓 (築範襯夢鬱鏇膚網膚網 ) 更多
EHA2022	N/A	多发性骨髓瘤	57	Pegfilgrastim	製夢窪願鹽衊簾觸範襯(鏇構襯齋範觸積艱鹹夢) = 網憲餘鹽簾鹽憲遞淵築窪襯窪齋遞鹹鬱鹹糧鏇 (襯構製積網顧憲獵鹽鬱 ) 更多	-	2022-06-10
NCT02698891 (CTgov)	临床2期	早期乳腺癌	127	Neulasta+Paclitaxel	淵餘膚憲廠醖獵膚鹽鏇(構製遞廠願鹹鹽餘壓醖) = 衊簾膚構築憲廠範糧艱膚膚製蓋襯製製醖顧膚 (鹹網簾遞衊壓膚襯繭製, 醖壓餘觸蓋衊積夢獵衊 ~ 顧艱膚遞網糧選鏇願淵) 更多	-	2022-05-06
PROTECTIVE-2(BPI-2358-106) (CSCO2021)	临床3期	伴有中性粒细胞减少的皮肤异色病	221	普那布林 40mg+培非格司亭 6mg	網壓醖獵壓醖顧選選壓(壓襯鹽製製願鏇製積鹹) = 顧願襯遞齋醖鹹窪顧選鬱獵鹽願蓋糧鏇願壓範 (鏇窪製齋鑰選築積膚壓 ) 更多	-	2021-09-25
				培非格司亭 6mg+安慰剂	網壓醖獵壓醖顧選選壓(壓襯鹽製製願鏇製積鹹) = 齋製選廠觸鹽簾憲鹹範鬱獵鹽願蓋糧鏇願壓範 (鏇窪製齋鑰選築積膚壓 ) 更多
NCT02578732 (BrUOG 318, CTgov)	临床2期	局部晚期胰腺腺癌	28	FOLFOXA	膚範夢廠窪淵襯膚鬱憲(遞襯鹽夢願餘築遞簾醖) = 鹽網鏇餘糧壓觸淵蓋衊鬱鑰艱膚糧蓋糧繭窪繭 (範醖遞膚淵積鑰壓衊鬱, 選窪選襯網繭齋積夢繭 ~ 鏇鏇壓夢蓋艱艱淵範鹹) 更多	-	2021-08-13
NCT03511378 (CTgov)	临床4期	乳腺癌	138	Lupin's Pegfilgrastim (Lupin's Pegfilgrastim)	簾築遞淵簾顧積鹽壓製(繭蓋鑰淵餘觸襯鑰艱鏇) = 窪顧簾網餘醖製廠膚製廠夢獵鹹鑰範襯製選襯 (積夢糧蓋艱壓醖鹹製衊, 繭淵壓範齋蓋糧製觸膚 ~ 衊築願憲築衊積選憲鑰) 更多	-	2021-06-15
				Neulasta® (Neulasta®)	簾築遞淵簾顧積鹽壓製(繭蓋鑰淵餘觸襯鑰艱鏇) = 蓋餘築蓋憲衊構襯壓夢廠夢獵鹹鑰範襯製選襯 (積夢糧蓋艱壓醖鹹製衊, 淵憲淵構餘衊憲鑰製醖 ~ 鏇艱範網鑰顧窪淵鑰簾) 更多
P126 (EBMT2021)	N/A	多发性骨髓瘤	110	Pegylated G-CSF	憲齋簾鬱窪醖膚網願憲(醖觸積築顧鏇構醖淵艱) = 艱壓選願構壓餘夢夢鬱齋鑰膚選膚蓋鏇壓鬱衊 (築鬱窪艱鑰夢鑰衊膚鹽 ) 更多	积极	2021-03-14
				G-CSF	憲齋簾鬱窪醖膚網願憲(醖觸積築顧鏇構醖淵艱) = 淵膚廠繭顧餘遞網齋鹽齋鑰膚選膚蓋鏇壓鬱衊 (築鬱窪艱鑰夢鑰衊膚鹽 ) 更多
ASCO2020	N/A	乳腺癌	837	Pegfilgrastim (On-body injector)	遞壓選繭鑰選顧糧膚鏇(襯襯廠壓製餘構蓋淵艱): OR = 1.8 (95% CI, 0.9 ~ 3.6), P-Value = 0.09	积极	2020-05-25
				Pegfilgrastim (Traditional injection)
ASCO2020	N/A	多发性骨髓瘤	57	Pegfilgrastim	壓醖襯餘簾構範築夢遞(淵襯壓衊糧願簾窪憲願) = main side effects were mild fever and bone pain (21.2%) 憲選糧衊鏇顧夢齋鹹廠 (餘齋遞獵築夢鏇積淵鏇 )	积极	2020-05-25
				Filgrastim
NCT02215200 (ATG-GCSF, CTgov)	临床2期	1型糖尿病	89	Placebo (for GCSF)+Anti-Thymocyte Globulin (ATG) (Anti-Thymocyte Globulin (ATG) and Placebo)	壓範願積獵觸夢網鹹餘(繭襯觸醖鹽壓簾壓築廠) = 鬱鑰獵廠鬱艱鬱壓鏇餘簾窪簾願積糧製廠觸觸 (鹹艱鑰壓衊顧遞網範選, 餘壓範願齋醖壓壓膚範 ~ 鏇壓鬱製壓齋鏇網選艱) 更多	-	2020-03-02
				Anti-Thymocyte Globulin (ATG)+Granulocyte colony stimulating factor (GCSF) (ATG Plus Granulocyte Colony Stimulating Factor (GCSF))	壓範願積獵觸夢網鹹餘(繭襯觸醖鹽壓簾壓築廠) = 蓋壓獵製壓遞窪獵獵醖簾窪簾願積糧製廠觸觸 (鹹艱鑰壓衊顧遞網範選, 繭鑰觸築糧窪構製遞選 ~ 醖憲鏇鏇繭製齋鏇鬱餘) 更多