Study to investigate the safety and activity of NEO-PTC-01 in patients with unresectable or metastatic melanoma. NEO-PTC-01 is an autologous personalized T cell (PTC) product for adoptive cell therapy that is manufactured ex vivo and targets neoantigens displayed on the patient's tumor and the tumor microenvironment.
The study will be conducted in two parts, Part 1 (Dose Finding) and Part 2 (Dose Expansion). The dose-finding part of the study will test two doses of NEO-PTC-01 and will be structured according to a 3+3 dose escalation design. After the highest tolerated NEO-PTC-01 dose is identified, 2 additional evaluations in Part 1 are planned, a cohort to investigate NEO-PTC-01 in combination with interleukin (IL)-2 and another cohort introducing α programmed cell death protein 1 (αPD-1) therapy. The dose expansion part of the study will test the dose deemed to be safe in the dose-finding part of the study in an expanded cohort of patients to further define the safety of NEO-PTC-01.

开始日期2020-12-01

申办/合作机构

BioNTech US, Inc.

NCT03597282 / Terminated临床1期

An Open-label, Phase 1B Study of NEO-PV-01 + CD40 Agonist Antibody (APX005M) or Ipilimumab With Nivolumab in Patients With Advanced or Metastatic Melanoma

The primary purpose of this study is to demonstrate that the NEO-PV-01 vaccine, either with APX005M or ipilimumab, and nivolumab is safe for the treatment of patients with advanced or metastatic melanoma. The study will also investigate an alternative schedule for the administration of the NEO-PV-01 vaccine. Study interventions will be assessed by both clinical and immune responses to treatment.

开始日期2018-10-08

申办/合作机构

BioNTech US, Inc.

[+1]

NCT03380871 / Completed临床1期

An Open-Label, Phase 1B Study of NEO-PV-01 With Pembrolizumab Plus Chemotherapy in Patients With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer

The purpose of this study is to find out if treatment with NEO-PV-01 in combination with pembrolizumab and chemotherapy (pembrolizumab/chemotherapy) is safe and useful for patients with lung cancer. The study also will assess if the NEO-PV-01 vaccine, when given together with pembrolizumab and chemotherapy, can improve your response compared with pembrolizumab and chemotherapy treatment alone. All eligible patients will receive NEO-PV-01 + Adjuvant, pembrolizumab and chemotherapy while on this trial.

开始日期2018-05-04

申办/合作机构

BioNTech US, Inc.

[+1]

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项与 BioNTech US, Inc. 相关的文献（医药）

2024-06-01·Advances in therapy

Treatment-Free Interval: A Novel Approach to Assessing Real-World Treatment Effectiveness and Economic Impact Among Patients with Irritable Bowel Syndrome with Diarrhea

Article

作者: Guérin, Annie ; Dashputre, Ankur A ; Lacy, Brian E ; Bumpass, Brock ; Heimanson, Zeev ; Gagnon-Sanschagrin, Patrick ; Bungay, Rebecca ; Joseph, George ; Borroto, Danellys ; Bellefleur, Remi

INTRODUCTION:

Objective assessment of treatment effectiveness using real-world claims data is challenging. This study assessed treatment-free intervals (TFI) as a proxy for treatment effectiveness, and all-cause healthcare costs among adult patients with irritable bowel syndrome with diarrhea (IBS-D) treated with rifaximin or eluxadoline in the USA.

METHODS:

Adult patients (18-64 years) with IBS-D and ≥ 1 rifaximin or eluxadoline prescription were identified in the IQVIA PharMetrics^® Plus database (10/01/2015-12/31/2021) and classified into two mutually exclusive cohorts (i.e., rifaximin and eluxadoline). Index date was the date of rifaximin or eluxadoline initiation. Entropy-balanced baseline characteristics, TFI (periods of ≥ 30 consecutive days without IBS-D treatment), and healthcare costs were reported. Healthcare costs were compared between cohorts using mean cost differences.

RESULTS:

There were 7094 and 2161 patients in the rifaximin and eluxadoline cohorts, respectively. After balancing, baseline characteristics (mean age 44.1 years; female 72.4%) were similar between cohorts. A higher proportion of patients treated with rifaximin achieved a TFI of ≥ 30 days (76.2% vs. 66.7%), ≥ 60 days (67.0% vs. 47.0%), ≥ 90 days (61.0% vs. 38.7%), ≥ 180 days (51.7% vs. 31.0%), and ≥ 240 days (47.7% vs. 27.9%) compared to eluxadoline. Among patients with a TFI ≥ 30 days, mean TFI durations were 8.3 and 6.0 months for the rifaximin and eluxadoline cohorts. Mean all-cause healthcare costs were lower for rifaximin vs. eluxadoline ($18,316 vs. $23,437; p = 0.008), primarily driven by pharmacy costs ($7348 vs. $10,250; p < 0.001). In a simulated health plan of one million commercially insured lives, initiating 50% of patients on rifaximin instead of eluxadoline resulted in total cost savings of $2.1 million per year or $0.18 per-member-per-month.

CONCLUSIONS:

This real-world study suggests that TFI is a meaningful surrogate measure of treatment effectiveness in IBS-D. Patients treated with rifaximin had longer treatment-free periods and lower healthcare costs than patients treated with eluxadoline.

2024-05-22·Science Translational Medicine

Preclinical efficacy and pharmacokinetics of an RNA-encoded T cell–engaging bispecific antibody targeting human claudin 6

Article

作者: Fischer, Leyla ; Hebich, Bernhard ; Bähr-Mahmud, Hayat ; Ellinghaus, Ursula ; Türeci, Özlem ; Biermann, Imke ; Şahin, Uğur ; Chaturvedi, Anuhar ; Malz, Alexandra ; Stadler, Christiane R ; Wolf, Kristina ; Beresin, Georg ; Scharf, Caroline ; Häcker, Aline ; Kullmann, Maximilian ; Rao, Martin ; Lindemann, Claudia ; Falck, Georg ; Houben, Astrid ; Chang, Philip ; Erdeljan, Michael

We present the preclinical pharmacology of BNT142, a lipid nanoparticle (LNP)–formulated RNA (RNA-LNP) encoding a T cell–engaging bispecific antibody that monovalently binds the T cell marker CD3 and bivalently binds claudin 6 (CLDN6), an oncofetal antigen that is absent from normal adult tissue but expressed on various solid tumors. Upon BNT142 RNA-LNP delivery in cell culture, mice, and cynomolgus monkeys, RNA is translated, followed by self-assembly into and secretion of the functional bispecific antibody RiboMab02.1. In vitro, RiboMab02.1 mediated CLDN6 target cell–specific activation and proliferation of T cells, and potent target cell killing. In mice and cynomolgus monkeys, intravenously administered BNT142 RNA-LNP maintained therapeutic serum concentrations of the encoded antibody. Concentrations of RNA-encoded RiboMab02.1 were maintained longer in circulation in mice than concentrations of directly injected, sequence-identical protein. Weekly injections of mice with BNT142 RNA-LNP in the 0.1- to 1-μg dose range were sufficient to eliminate CLDN6-positive subcutaneous human xenograft tumors and increase survival over controls. Tumor regression was associated with an influx of T cells and depletion of CLDN6-positive cells. BNT142 induced only transient and low cytokine production in CLDN6-positive tumor-bearing mice humanized with peripheral blood mononuclear cells (PBMCs). No signs of adverse effects from BNT142 RNA-LNP administration were observed in mice or cynomolgus monkeys. On the basis of these and other findings, a phase 1/2 first-in-human clinical trial has been initiated to assess the safety and preliminary efficacy of BNT142 RNA-LNP in patients with CLDN6-positive advanced solid tumors (NCT05262530).

2024-01-01·Nature medicine1区 · 医学

A candidate antibody drug for prevention of malaria

1区 · 医学

Article

作者: Siska, Christine ; Jepson, Sofia Z ; Guerrero, Steve ; Tomaras, Georgia D ; Chen, Xiaomu ; Li, Kan ; Williamson, Kevin S ; Dennison, S Moses ; Smidt, Pauline ; Tan, Yann Chong ; King, C Richter ; Flores-Garcia, Yevel ; MacGill, Randall S ; Emerling, Daniel E ; Williams, Katherine L ; Walker, Michael ; Cavet, Guy ; Mathis-Torres, Shamika ; Jongert, Erik ; Lippow, Shaun M ; Ockenhouse, Christian ; Robinson, William H ; Wille-Reece, Ulrike ; Kim, Dongkyoon ; Ketchem, Randal R ; Moon, James E ; Zavala, Fidel ; Glanville, Jacob ; Dutta, Sheetij ; Regules, Jason A

Abstract:

Over 75% of malaria-attributable deaths occur in children under the age of 5 years. However, the first malaria vaccine recommended by the World Health Organization (WHO) for pediatric use, RTS,S/AS01 (Mosquirix), has modest efficacy. Complementary strategies, including monoclonal antibodies, will be important in efforts to eradicate malaria. Here we characterize the circulating B cell repertoires of 45 RTS,S/AS01 vaccinees and discover monoclonal antibodies for development as potential therapeutics. We generated >28,000 antibody sequences and tested 481 antibodies for binding activity and 125 antibodies for antimalaria activity in vivo. Through these analyses we identified correlations suggesting that sequences in Plasmodium falciparum circumsporozoite protein, the target antigen in RTS,S/AS01, may induce immunodominant antibody responses that limit more protective, but subdominant, responses. Using binding studies, mouse malaria models, biomanufacturing assessments and protein stability assays, we selected AB-000224 and AB-007088 for advancement as a clinical lead and backup. We engineered the variable domains (Fv) of both antibodies to enable low-cost manufacturing at scale for distribution to pediatric populations, in alignment with WHO’s preferred product guidelines. The engineered clone with the optimal manufacturing and drug property profile, MAM01, was advanced into clinical development.

项与 BioNTech US, Inc. 相关的新闻（医药）

2024-05-14

·BioSpace

Vicore Expands and Strengthens its Board of Directors

STOCKHOLM, SWEDEN / ACCESSWIRE / May 14, 2024 / Vicore Pharma Holding (STO:VICO) Stockholm, May 14, 2024 - Vicore Pharma Holding AB, a clinical-stage biopharmaceutical company unlocking the potential of a new class of drug candidates, angiotensin II type 2 receptor agonists (ATRAGs), is pleased to announce the election of Hans Schikan, PharmD, as the new Chair of the Board of Directors as well as the election of two new Board members, Ann Barbier, MD, PhD and Yasir Al-Wakeel BM, BCh. Hans Schikan has been a member of the Board since 2018 and is a leader in rare disease drug development and strategy. He was previously CEO of Prosensa (Nasdaq: RNA), a company developing therapies for rare diseases including Duchenne muscular dystrophy acquired by BioMarin. He is also co-founder and Vice-Chair of Pharvaris (Nasdaq: PHVS), a clinical stage company developing therapies for the rare disease hereditary angioedema. Prior to Pharvaris and Prosensa, Hans Schikan was an executive at rare disease pioneer Genzyme. He also served on the boards of Wilson Therapeutics (Nasdaq Stockholm: WTX), acquired by Alexion, Therachon, acquired by Pfizer, and VectivBio (Nasdaq: VECT), acquired by Ironwood. "It has been a privilege to serve on the Vicore Board and I am pleased to be taking on an expanded role with the company," said Hans Schikan. "I am looking forward to leading the Board as the company seeks to drive transformational impact for patients suffering from idiopathic pulmonary fibrosis and advance its leadership in angiotensin II pathway biology and drug discovery." Ann Barbier, MD, PhD, has more than 20 years of experience in drug discovery and development in rare diseases, including rare respiratory diseases She previously served as Chief Medical Officer of Translate Bio (Nasdaq: TBIO), a biotechnology company developing drugs for rare respiratory diseases acquired by Sanofi as well as Chief Medical Officer at CAMP4 Therapeutics. "Idiopathic pulmonary fibrosis is a huge unmet medical need and the data generated by the Vicore team to date reflect disease modifying potential for patients who have limited options today," said Ann Barbier. "I am proud to join Vicore's effort to impact this disease and look forward to serving on the Board as the company advances to Phase 2b development of buloxibutid." Yasir Al-Wakeel is a leader in biotech strategic finance and business development. He is currently the CEO of a private biotech company and member of the Maxcyte (Nasdaq: MXCT) board. Yasir Al-Wakeel was previously the Chief Financial Officer and Head of Corporate Development at Kronos Bio (Nasdaq: KRON), Chief Financial and Strategy Officer at Neon Therapeutics (Nasdaq: NTGN), acquired by BioNTech, and Chief Financial Officer and Head of Corporate Development at Merrimack Pharmaceuticals (Nasdaq: MACK), leading its 1 billion USD asset sale to Ipsen. "Vicore's potential therapy for IPF is incredibly promising and I am excited to join the Vicore Board as the company seeks to expand its global footprint as it advances to late-stage development of buloxibutid," said Yasir Al-Wakeel. "I am looking forward to leveraging my experience in both strategic finance and corporate development during this important time for the company." This information was submitted for publication on May 14, 2024, at 08:00 CET. About Vicore Pharma Holding AB (publ) Vicore is an innovative clinical-stage pharmaceutical company unlocking the potential of a new class of drugs with disease-modifying potential. The company is establishing a portfolio in respiratory diseases, including idiopathic pulmonary fibrosis (IPF). Buloxibutid (C21) is a first-in-class orally available small molecule angiotensin II type 2 receptor agonist (ATRAG) currently in phase 2a development for IPF. Almee™ (an investigational medical device in clinical development) is a digital therapeutic based on cognitive behavioral therapy created to address the psychological impact of living with pulmonary fibrosis. Almee has received Breakthrough Device Designation from the FDA, reflecting its potential to have transformative impact. Using its unique expertise in ATRAG chemistry and biology, Vicore is further fueling its pipeline with several new therapies across additional potential indications. The company's shares (VICO) are listed on Nasdaq Stockholm's main market. For more information, see . Attachments Vicore Expands and Strengthens its Board of Directors SOURCE: Vicore Pharma Holding View the original press release on accesswire.com

临床2期高管变更并购

2024-05-05

·药通社

全球45家医药巨头最新财报速览汇总

百济、正大天晴、丽珠等已报名！点击上图，获取参会信息！注：各大公司财政年度的起始时间不同于自然年，因此会出现财政季度、年度等与自然年不一致的情况。美国艾伯维(AbbVie)公布2023年第四季度和全年业绩。季度净营收143亿美元，上年同期为151亿美元。季度归属公司净利润8.22亿美元，上年同期为24.73亿美元。2023年净营收543亿美元，2022年为581亿美元。全年归属公司净利润48.63亿美元，上年为118.36亿美元。辉瑞(Pfizer)公布2023年第四季度和全年业绩。第四季度营收142.49亿美元，上年同期为242.9亿美元，同比下降41%。季度净亏损33.7亿美元，上年同期净利润50亿美元。2023年营收585亿美元，2022年为1003亿美元，同比下降42%。全年净利润21.2亿美元，2022年为313.7亿美元，同比下降93%。强生公司(Johnson & Johnson)公布2023年第四季度业绩。季度销售额为214亿美元，同比增长7.3%。净利润为41.3亿美元，上年同期为为32.3亿美元。按业务划分，不包括新冠疫苗的销售，制药业务销售额为136.8亿美元。强生医疗设备业务销售额为76.7亿美元，同比增长13.3%。默沙东(Merck & Co., Inc.)公布2023年第四季度和全年业绩。第四季度销售额146.3亿美元，上年同期为138.3亿美元，同比增长6%。季度归属公司净亏损12.26亿美元，上年同期净利润30.17亿美元。其中，制药业务销售额131.41亿美元，同比增长8%。动物保健业务销售额12.78亿美元，同比增长4%。全年销售额600.15亿美元，上年为592.83亿美元。全年归属公司净利润3.65亿美元，上年净利润145.19亿美元。百时美施贵宝(Bristol-Myers Squibb)公布2023年第四季度和全年业绩。第四季度总营收114.77亿美元，上年同期为114.06亿美元。季度归属公司净利润17.62亿美元，上年同期净利润20.22亿美元。全年总营收450亿美元，上年为462亿美元。全年归属公司净利润80.25亿美元，上年净利润63.27亿美元。制药公司礼来(Eli Lilly)发布2023年第四季度财报。季度总营收为93.5亿美元，同比增长28%。净利润为21.9亿美元，上年同期净利润为19.4亿美元。安进(Amgen Inc.)公布2023年第四季度和全年业绩。第四季度总营收81.96亿美元，上年同期为68.39亿美元。季度净利润7.67亿美元，上年同期为16.16亿美元，同比增长52%。2023年总营收281.9亿美元，2022年为263.23亿美元。全年净利润67.17亿美元，上年为65.52亿美元。吉利德科学(Gilead Sciences)公布2023年第四季度和全年业绩。第四季度总营收71.15亿美元，上年同期为73.89亿美元。季度归属公司净利润14.29亿美元，上年同期为16.4亿美元。全年总营收271.16亿美元，上年为272.81亿美元。全年归属公司净利润56.65亿美元，上年为45.92亿美元。晖致(Viatris)公布2023年第四季度和全年业绩。第四季度总营收38.37亿美元，上年同期为38.76亿美元。季度净亏损7.66亿美元，上年同期净利润10.11亿美元。全年总营收154.27亿美元，上年为162.63亿美元。全年净利润5470万美元，上年为20.79亿美元。再生元制药(Regeneron)公布2023年第四季度和全年业绩。第四季度总营收34.34亿美元，上年同期为34.14亿美元。季度净利润11.6亿美元，上年同期为11.97亿美元。全年总营收131.17亿美元，上年为121.73亿美元。全年净利润39.54亿美元，上年为43.38亿美元。渤健(Biogen)公布2023年第四季度和全年业绩。第四季度总营收23.86亿美元，上年同期为25.44亿美元。季度归属公司净利润2.5亿美元，上年同期为5.5亿美元。全年总营收98.36亿美元，上年为101.73亿美元。全年归属公司净利润11.6亿美元，上年为30.5亿美元。福泰制药(Vertex Pharmaceuticals)公布2023年第四季度和全年业绩。第四季度产品净营收25.18亿美元，上年同期为23.03亿美元。季度净利润9.69亿美元，上年同期为8.19亿美元。全年产品净营收98.69亿美元，上年为89.31亿美元。全年净利润36.2亿美元，上年为33.2亿美元。莫德纳(Moderna)公布2023年第四季度和全年业绩。第四季度总营收28.11亿美元，上年同期为50.84亿美元。季度净利润2.17亿美元，上年同期为14.65亿美元。全年营收68.48亿美元，上年为192.63亿美元。全年净亏损47.14亿美元，上年净利润83.62亿美元。欧加隆(Organon)公布2023年第四季度和全年业绩。第四季度营收15.98亿美元，上年同期为14.85亿美元。季度净利润5.46亿美元，上年同期为1.08亿美元。全年营收62.63亿美元，上年为61.74亿美元。全年净利润10.23亿美元，上年为9.17亿美元。雅培(Abbott)公布2023年第四季度业绩。季度营收同比增长1.5%至102.4亿美元。按业务划分，医疗设备部门营收为44.4亿美元，同比增长17.5%。营养业务营收为20.4亿美元，同比增长12%。诊断业务营收为25.3亿美元，同比下降23%。仿制药业务销售额为12.2亿美元，同比增长0.5%。季度净利润15.94亿美元，上年同期为10.33亿美元。欧洲罗氏(Roche)公布2023年业绩。全年集团销售额587.16亿瑞士法郎，上年为632.81亿瑞士法郎。其中，制药业务销售额446.12亿瑞士法郎(约489亿美元)，营业利润171.32亿瑞士法郎。诊断业务销售额141.04亿瑞士法郎，营业利润21.71亿瑞士法郎。全年归属公司股东的净利润114.98亿瑞士法郎，上年同期为124.21亿瑞士法郎。阿斯利康(AstraZeneca)公布2023年第四季度和全年财务业绩。第四营收为120.24亿美元，上年同期为112.07亿美元。季度税后利润9.59亿美元，上年同期为9.02亿美元。全年总营收为458.11亿美元，上年为443.51亿美元。全年税后利润59.61亿美元，上年同期为32.93亿美元。诺华集团(Novartis)公布2023年第四季度和全年财报。第四季度净销售额114.23亿美元，同比增长8%；季度净利润26.38亿美元，同比增长101%。全年净销售额为454亿美元，同比增长10%。其中，中国区净销售额为33亿美元，同比增长17%。赛诺菲(Sanofi)公布2023年第四季度和全年财报。第四季度总营收109亿欧元，同比增长9.3%。全年销售额达到430.7亿欧元，同比增长5.3%。其中，制药业务收入304亿欧元(约323亿美元)，疫苗业务收入75亿欧元(约79.6亿美元)，消费者保健业务收入52亿欧元。葛兰素史克(GSK)公布2023年第四季度和全年业绩。第四季度营业额80.52亿英镑(约100亿美元)，上年同期为73.76亿英镑。季度营业利润5.73亿英镑，上年同期为18.68亿英镑。季度持续经营业务归属股东的净利润3.5亿英镑，上年同期为15亿英镑。全年营业额303.28亿英镑(约377亿美元)，上年为293.24亿英镑。全年营业利润67.45亿英镑，上年为64.33亿英镑。全年持续经营业务归属股东的净利润49.28亿英镑，上年为44.61亿英镑。诺和诺德(Novo Nordisk)公布2023年业绩。全年营业利润按丹麦克朗计算增长37%，达到1026亿丹麦克朗，按不变汇率计算增长44%。销售额增长31%，至2323亿克朗(约331亿美元)，按不变汇率计算增长36%。司美格鲁肽作为诺和诺德的明星产品，2023年共取得了1458.11 亿丹麦克朗的收入。勃林格殷格翰(Boehringer-Ingelheim)发布2023年全年业绩表现。2023年全年集团销售收入同比增长9.7%至256.11亿欧元。其中，人用药品销售收入总额207.74亿欧元(约221亿美元)，同比增长10.3%。动物保健业务销售收入47.24亿欧元，同比增长6.9%。全年研发投入同比增长14.2%，达58亿欧元，研发投入占销售收入的比重高达22.5%。拜耳(Bayer Group)公布2023年第四季度和全年业绩。第四季度集团销售额118.62亿欧元，上年同期为120亿欧元。季度净利润13.37亿欧元，上年同期为6.11亿欧元。按业务划分，作物科学部门销售额56.3亿欧元，EBIT利润9.75亿欧元。制药部门销售额45.79亿欧元(约48.6亿美元)，EBIT利润9.35亿欧元。消费者健康部门销售额15.78亿欧元，EBIT利润4.24亿欧元。集团全年销售额476.37亿欧元，上年为507.39亿欧元。全年归属公司股东净亏损29.41亿欧元，上年净利润41.5亿欧元。德国制药和化工巨头默克集团(Merck Group)公布2023年第四季度和全年业绩。第四季度净销售额52.25亿欧元，上年同期为56.6亿欧元。其中，生命科学业务净销售额22.49亿欧元(约23.88亿美元)，医药健康业务净销售额20.32亿欧元(约21.57亿美元)，电子科技业务净销售额9.43亿欧元。全年净销售额209.93亿欧元，上年为222.32亿欧元。全年EBITDA利润54.89亿欧元，上年为65.04亿欧元。全年税后利润28.34亿欧元，上年为33.39亿欧元。山德士(Sandoz)公布2023年第四季度和全年业绩。第四季度销售额25.43亿美元，上年同期为22.96亿美元。全年销售额96.47亿美元，上年为90.69亿美元。全年EBITDA利润9.14亿美元，上年为17.41亿美元。费森尤斯集团(FRESENIUS GROUP)公布2023年第四季度和全年业绩。季度集团营收56.78亿欧元，EBITDA利润9.42亿欧元，净利润3.97亿欧元。其中，费森尤斯卡比营收19.96亿欧元(约21.2亿美元)，上年同期为20.36亿欧元。费森尤斯赫里奥斯诊所营收31.88亿欧元，上年同期为30.31亿欧元。集团全年营收222.99亿欧元，EBITDA利润34.22亿欧元，净利润15.05亿欧元。基立福(Grifols)公布2023年第四季度和全年业绩。季度营收17.7亿欧元(约18.8亿美元)，上年同期为17.1亿欧元。季度营业利润(EBIT)2.55亿欧元，持续经营利润7773万欧元。全年营收65.9亿欧元(约70亿美元)，上年为60.6亿欧元。全年营业利润(EBIT)7.99亿欧元，持续经营利润1.81亿欧元。优时比(UCB)公布2023年业绩。全年营收52.52亿欧元(约55.8亿美元)，上年为55.17亿欧元。全年调整后的EBITDA利润13.49亿欧元，上年为12.6亿欧元。全年归属公司股东的净利润3.43亿欧元，上年为4.18亿欧元。百欧恩泰(BioNTech)公布2023年第四季度和全年业绩。第四季度总营收14.79亿欧元(约15.7亿美元)，上年同期为42.78亿欧元。季度净利润4.58亿欧元，上年同期为22.79亿欧元。全年总营收38.19亿欧元(约40.55亿美元)，上年为173.11亿欧元。全年净利润9.3亿欧元，上年净利润94.34亿欧元。生物制药公司益普生(Ipsen)公布2023年全年财务业绩。全年总销售额31.28亿欧元(约33.2亿美元)，上年为30.25亿欧元。全年核心营业利润10亿欧元，上年为11.15亿欧元。全年核心合并净利润7.66亿欧元，上年为8.72亿欧元。亚太武田(Takeda Pharmaceutical)公布截至2023年12月31日的财年前九个月(4月-12月)业绩。当期营收32129亿日元(约208亿美元)，上年同期30713亿日元，同比增4.6%。当期营业利润2241亿日元，上年同期4019亿日元，同比下降44.2%。当期归属公司所有者净利润1471亿日元，上年同期2859亿日元，同比下降48.6%。澳大利亚生物制药公司CSL Group公布截至2023年12月底的上半财年业绩。当期集团总营收80.53亿美元，上年同期为71.84亿美元。当期营业利润37.87亿美元，上年同期为33.59亿美元。当期归属于公司的净利润20.17亿美元，上年同期为18.18亿美元。其中，CSL Behring营收52.38亿美元，CSL Seqirus营收18.04亿美元，CSL Vifor营收10.11亿美元。梯瓦制药(Teva Pharmaceutical Industries)公布2023年第四季度和全年业绩。第四季度净营收44.57亿美元，上年同期为38.84亿美元。季度归属公司净利润4.61亿美元，上年同期净亏损13亿美元。全年净营收158.46亿美元，上年为149.25亿美元。全年归属公司净亏损5.59亿美元，上年净亏损24.46亿美元。安斯泰来(Astellas Pharma Inc.)公布截至2023年12月31日的财年前九个月(4月-12月)业绩。当期营收11891亿日元(约77亿美元)，上年同期11643亿日元，同比增2.1%。当期营业利润1496亿日元，上年同期2337亿日元，同比下降36%。当期净利润1205亿日元，上年同期1889亿日元，同比下降36.2%。第一三共(Daiichi Sankyo Company, Limited)公布截至2023年12月31日的财年前九个月(4月-12月)业绩。当期营收11733亿日元(约76亿美元)，上年同期9483亿日元，同比增长23.7%。当期营业利润1946亿日元，上年同期1271亿日元，同比增长53%。当期归属公司所有者的净利润1636亿日元，上年同期867亿日元，同比增长88.7%。大冢控股(Otsuka Holdings Co., Ltd.)公布2023年业绩。全年营收20186亿日元，上年为17380亿日元。全年营业利润1396亿日元，上年为1503亿日元。全年归属于公司所有者的净利润1216亿日元，上年为1339亿日元。其中，制药业务营收13643亿日元(约88.3亿美元)，营养品业务营收4837亿日元，消费品业务营收371亿日元。卫材(Eisai Co., Ltd.)公布截至2023年12月31日的财年前九个月(4月-12月)业绩。当期营收5513亿日元(约35.7亿美元)，上年同期5462亿日元，同比增长0.9%。当期营业利润375.37亿日元，上年同期138.23亿日元，同比增长172%。当期归属母公司所有者的净利润291亿日元，上年同期391亿日元，同比下降25.6%。中国恒瑞医药发布2023年度报告。公司实现营业收入228.2亿元，同比增长7.26%，归属于上市公司股东的净利润43.02亿元，同比增10.14%，归属于上市公司股东的扣非净利润41.41亿元，同比增21.46%。2023年，公司创新药收入达106.37亿元(含税，不含对外许可收入)，虽然面临外部环境变化、产品降价及准入难等因素影响，仍然实现了同比22.1%的增长。翰森制药发布2023年度业绩。报告期内实现营业收入人民币101.04亿元，较去年同期增长约7.7%，净利润32.78亿元，较去年同期增长约26.9%。2023年翰森制药创新药与合作产品收入约68.65亿元，同比增长约37.1%。2023年翰森制药研发开支约为20.97亿元，同比增长约23.8%，占总收入比例增至20.8%。复星医药发布2023年报。全年实现营业收入414亿元，同比下降5.81%；归属于上市公司股东的净利润23.86亿元，同比下降36.04%。2023年，复星医药的制药业务实现收入302.22亿元，医疗器械与医学诊断业务实现营业收入43.90亿元，医疗健康服务业务实现营业收入66.72亿元，同比增加9.74%。中国生物制药发布2023年度业绩。全年营收262亿人民币，同比增长0.7%。经调整后归母净利润25.9亿，同比增长1.5%。创新产品收入达到98.9亿元，同比增加13.3%。研发费用2023年投入44亿元，占比达到16.8%。石药集团披露2023年全年业绩。公司实现营收314.5亿元，同比增长1.7%；实现净利58.7亿元，同比减少3.6%。其中，成药实现营收256.37亿元，同比增长4.6%，原料产品、功能食品及其他分别实现营收36.41亿元、21.72亿元，分别同比下降9.7%、8.9%。上海医药发布2023年度报告。2023年，公司实现营收2602.95亿元，同比增长12.21%，其中，医药工业实现销售收入262.57亿元，同比下降1.87%；医药商业实现销售收入2340.38亿元，同比增长14.04%。受一次性损益的影响，归母净利润37.68亿元，同比下降32.92%；剔除一次性损益影响后，归母净利润为49.19亿元，同比增长2.99%。华润医药集团公布2023年业绩。2023年收益人民币2447亿元，2022年为2182亿元。本公司权益持有人应占溢利38.54亿元，上年为35亿元。报告期内，华润医药中药业务板块实现营收215.93亿元；化学药业务实现营收170.32亿元；生物药实现营收21.36亿元；营养保健品及其他业务实现营收27.04亿元。集团医药分销业务实现分部收益2023亿元，同比增长11.4%。医药零售业务录得收益95.78亿元，同比增长26.2%。白云山(广州药业)披露2023年第四季度和全年业绩。第四季度营业收入173.3亿元，归属公司股东净利润2.64亿元。全年营业收入755.15亿元，比上年增长6.68%。全年归属公司股东净利润40.56亿元，同比增长2.25%。其中，中成药业务营业收入62.7亿元，化学药营业收入46.18亿元。来源：新康界推荐阅读复杂注射剂研发技术有何要求？长效微球制剂研发与产业化有何难点？↓↓↓↓参会即知！↓↓↓↓

财报疫苗

2024-05-04

·医药观澜

普米斯抗PD-L1/VEGF双抗获批3期临床试验，一线治疗三阴性乳腺癌

▎药明康德内容团队编辑近日，普米斯宣布其自主研发的抗PD-L1/VEGF双特异性抗体新药PM8002注射液获中国国家药品监督管理局药品审评中心（CDE）批准开展一项多中心、随机、双盲注册性3期临床试验，针对的适应症为——PM8002注射液或安慰剂联合注射用白蛋白结合型紫杉醇一线治疗不可手术的局部晚期/复发转移性三阴性乳腺癌。PM8002是一款双特异性抗体药物，由人源化的抗PD-L1单域抗体（VHH）融合到一个含有Fc-沉默突变的抗VEGF-A IgG1抗体上构成，现已在中国开展针对三阴性乳腺癌、小细胞肺癌、非小细胞肺癌、宫颈癌等多个癌种的多项2期临床研究。2023年11月，BioNTech公司已与普米斯生物达成一项超10亿美元的合作，获得该产品在全球（大中华区除外）的开发、生产和商业化权利。三阴性乳腺癌恶性程度较高、易复发，患者5年生存率较低。根据普米斯于圣安东尼奥乳腺癌大会（SABCS）2023年会上展示的临床数据，PM8002联合白蛋白紫杉醇方案在晚期三阴性乳腺癌的一线治疗中显示出令人鼓舞的抗肿瘤活性和良好的安全性，患者的客观缓解率（ORR）达78.6%，疾病控制率（DCR）达95.2%。2024年3月，PM8002注射液联合注射用白蛋白结合型紫杉醇一线治疗不可手术的局部晚期/复发转移性三阴性乳腺癌已被CDE纳入突破性治疗品种。普米斯联合创始人、董事长兼首席执行官刘晓林先生表示，PM8002获批开展注册性3期临床试验是普米斯抗体新药开发道路上的重要里程碑，标志着普米斯从早期临床阶段的生物技术公司转变为拥有处于临床后期开发阶段品种的生物制药公司。公司将继续以科学严谨的态度开展3期临床试验，同时进行其他适应症的探索，希望PM8002早日上市造福广大患者。参考资料：[1]普米斯宣布PM8002（抗PD-L1/VEGF双抗）获CDE批准开展注册性III期临床试验. Retrieved Apr 30 , 2024, from https://mp.weixin.qq.com/s/Bjmyziew6G6gp1XBVE-Bfg[2]普米斯宣布与BioNTech（百欧恩泰）达成战略合作. Retrieved Nov 6， 2023. From https://mp.weixin.qq.com/s/keoC7FPwB3Q82X1KffuQhQ[3]SABCS 2023 | 普米斯公布双特异性抗体PM8002联合白蛋白紫杉醇一线治疗晚期三阴性乳腺癌的最新临床进展. Retrieved Dec 13， 2023. From https://mp.weixin.qq.com/s/x-tom4breMTsqH70AHn24Q本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈。转发授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

临床3期突破性疗法上市批准临床2期

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药物(靶点)	适应症	全球最高研发状态

BNT-221	不可切除的黑色素瘤更多	临床1期
SARS-CoV-2 B.1.351 vaccine (Pfizer)	冠状病毒感染更多	临床前
BNT-162b4 ( SARS-CoV-2 M protein x SARS-CoV-2 N protein x SARS-CoV-2 ORF1Ab )	新型冠状病毒感染更多	临床前
Sotigalimab ( CD40 )	转移性黑色素瘤更多	终止
NEO-PV-01	转移性非鳞状非小细胞肺癌更多	无进展