Shanghai, China, January 5th, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that ASTRUM-004, Henlius’ pivotal phase 3 clinical study of anti-PD-1 mAb HANSIZHUANG (serplulimab) plus chemotherapy as first-line treatment for previously untreated locally advanced or metastatic squamous non-small-cell lung cancer (sqNSCLC), was published in Cancer Cell, a highly regarded oncology journal with an impact factor of 50.3. This publication serves as further evidence of the exceptional performance of HANSIZHUANG in the field of lung cancer. The study was led by Professor Caicun Zhou from Shanghai Pulmonary Hospital. Results of the overall population ASTRUM-004 were initially presented at the IASLC 2023 World Conference on Lung Cancer (WCLC 2023) in the form of oral presentation. Additionally, the data from its Asian subgroup were showcased in a poster session at the European Society of Medical Oncology Asia (ESMO Asia) Congress 2023. Previously in 2022, the new drug application (NDA) of serplulimab for ...
中国北京、美国麻省剑桥和瑞士巴塞尔——2024年1月2日——百济神州(纳斯达克代码:BGNE;香港联交所代码:06160;上交所代码:688235)是一家全球性生物科技公司。公司今日宣布其PD-1抑制剂百泽安®(替雷利珠单抗)新适应症已获中国国家药品监督管理局(NMPA)批准,单药用于不可切除或转移性肝细胞癌(HCC)患者的一线治疗。 肝癌是中国常见的高发恶性肿瘤。2020年中国肝癌新发病例约41万,约占全球总数的一半;死亡病例约39.1万,是中国第二大肿瘤致死病因1。70%-80%的肝癌患者在诊断时已经是中晚期2,失去了手术或其他局部治疗机会,临床预后较差,5年生存率仅为12.1%3,亟需更多治疗手段改善患者生存。 百济神州高级副总裁、全球研发负责人汪来博士表示:“中国的HCC发病率近年来持续上升,存在较大的未被满足的临床需求。此次获批是替雷利珠单抗在肝癌领域的又一突破性进展,丰富了晚期HCC患者的一线治疗选择。我们期待这一全新的治疗方案能够惠及更多肝癌患者,进一步提升肝癌患者的生存获益。” 本次获批是基于RATIONALE 301(NCT03412773)的临床试验数据。该试验是一项随机、开放性的全球3期临床研究,从亚洲、欧洲和美国各研究中心共入组674例患者,旨在评估替雷利珠单抗对比索拉非尼作为不可切除的HCC成人患者一线治疗的效果。 此前,RATIONALE 301试验结果以最新突破口头报告的形式,公布于2022年在法国巴黎举办的欧洲肿瘤内科学会(ESMO)大会,并于今年荣登肿瘤领域著名期刊《美国医学会杂志-肿瘤学》(JAMA Oncology)。研究结果显示:与索拉非尼相比,替雷利珠单抗展示出在总生存期(OS)上的非劣效性结果。替雷利珠单抗的中位OS为15.9个月,而索拉非尼的OS为14.1个月;替雷利珠单抗具有更高的客观缓解率(ORR)(14.3% vs 5.4%)和更持久的缓解(中位缓解持续时间DoR分别为36.1个月和 11.0个月);替雷利珠单抗和索拉非尼治疗的安全性特征与既往研究一致。 中国药科大学附属南京天印山医院消化系统肿瘤首席专家和RATIONALE 301 试验的全球牵头研究者(Leading PI)秦叔逵教授表示:“RATIONALE 301是一项由中国专家主导的、具有前瞻性的、随机对照、全球多中心3期注册临床试验。在设计和优化研究方案阶段,就兼顾东、西方肝癌的高度异质性,同时充分结合中国国情、病人特点和实践经验;试验过程中科学实施,严格质控,数据翔实,从而获得了预期的结果,为晚期肝细胞癌患者的一线免疫治疗提供了新的选择和可靠的依据。” 秦教授进一步表示,“替雷利珠单抗在本项试验中,单药一线治疗肝癌即展现出优良的有效性、安全性和耐受性,带来了明显的生存获益,具有重要的临床价值。可以相信此次替雷利珠单抗获批一线治疗晚期肝细胞癌适应症后,除了可以单药使用,还将推动含替雷利珠单抗联合方案的临床应用及研究进展,为众多的肝癌患者带来生的希望。” 至此,替雷利珠单抗已有12项适应症获得NMPA批准,是目前在中国获批适应症数量最多的PD-1抑制剂,其中11项适应症已全部纳入国家医保药品目录,也是纳入国家医保药品目录获批适应症数量最多的PD-1抑制剂。 网址: https://www.beigene.com.cn/pressreleases/%e7%99%be%e6%b5%8e%e7%a5%9e%e5%b7%9epd-1%e6%8a%91%e5%88%b6%e5%89%82%e7%99%be%e6%b3%bd%e5%ae%89%ef%bc%88%e6%9b%bf%e9%9b%b7%e5%88%a9%e7%8f%a0%e5%8d%95%e6%8a%97%ef%bc%89%e5%9c%a8%e4%b8%ad%e5%9b%bd/
In 2022, fueled by its powerhouse COVID products, Pfizer became the first company in the history of the biopharma industry to top $100 billion in annual revenue. What would the New York drugmaker do for an encore? In 2023, Pfizer went from generating the most sales in the industry to gaining the most approvals. With seven FDA nods in 2023, Pfizer had more than double that of any other company. It’s also more than twice as many as every drugmaker over each of the last three years. You need to go back to 2019, when Novartis scored six approvals, to find a company that approached what Pfizer accomplished in 2023. Pfizer’s splurge included four approvals in a dizzying five weeks in May and June. And all but one of the seven products has been pegged by analysts as a potential blockbuster. Two of the newly approved Pfizer treatments were acquired ...
Here is a selection of recent executive hires, promotions and layoffs occurring across the healthcare industry. By KATIE ADAMS This roundup will be published monthly. It is meant to highlight some of healthcare’s recent hiring news and is not intended to be comprehensive. If you have news about an executive appointment, resignation or layoff that you would like to share for this roundup or the MedCity Moves podcast, please reach out to moves@medcitynews.com. Here is a selection of recent executive hires, promotions, departures and layoffs occurring across the healthcare industry. Hires Aledade, an independent primary care network focused on value-based care, brought Rosemary Weldon onto its team as its new chief product officer. She spent the last decade at CVS Health, where she most recently served as vice president of digital health product management. Amgen welcomed James Bradner to its C-suite, where he now serves as chief scientific officer and ...
ROCKVILLE, U.S. and SUZHOU, China, Jan 2, 2024 — Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that the first participant has been successfully dosed in a Phase 3 clinical trial (GLORY-2) of higher dose 9 mg mazdutide (Innovent R&D Code: IBI362) , a glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with obesity. This is also the fourth large-scale phase 3 clinical study of mazdutide.GLORY-2 plans to enroll 450 subjects and randomize to receive mazdutide 9 mg treatment or placebo. The primary endpoints include the percentage change in body weight from baseline to week 60 and the proportion of subjects with 5% or more body weight loss from baseline at week 60.A Phase 2 study conducted in Chinese people with obesity ...
Shanghai and Suzhou, TOKYO, December 28, 2023 – Elpiscience Biopharma, Ltd. (Chairman and CEO: Darren Ji, MD, Ph.D., “Elpiscience”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced a research collaboration and license agreement for novel bi-specific macrophage engagers, ES019 and another program. The two companies will collaboratively conduct early-stage research for these two programs. Elpiscience will also grant Astellas the right to add up to two additional programs to be included in the collaboration. If Astellas exercises its option, Elpiscience will grant Astellas the exclusive right to further research, develop, manufacture and commercialize the products for each program. Elpiscience is a privately held, clinical-stage biopharmaceutical company dedicated to developing next-generation immuno-oncology therapies for cancer patients worldwide. Their Bispecific Macrophage Engager Platform (BiME®) is anti-tumor associated antigen (TAA) and anti-signal-regulatory protein α (SIRPα) bispecific antibody-based platform to activate Tumor Associated Macrophage (TAM) phagocytosis killing towards ...
ROCKVILLE, Md. and SUZHOU, China, Dec 28, 2023 — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, and Xuanzhu Biopharma, today announce that they entered into a clinical trial collaboration and supply agreement for the combination therapies of sintilimab injection (brand name: TYVYT®) with KM-501, a novel HER-2 bispecific ADC, as potential treatment options for advanced solid tumors in China. Under the agreement, Innovent will supply sintilimab for the collaborated clinical trial. Xuanzhu Biopharma will conduct a Phase 1b clinical study to evaluate the anti-tumor activity and safety of the combination therapy of sintilimab with KM-501 in Chinese patients with advanced solid tumors. TYVYT® (sintilimab injection) is an innovative PD-1 inhibitor co-developed by Innovent and Eli Lilly and Company in China. It has been approved and included in ...
Shanghai, China, December 28, 2023 – Shanghai Henlius Biotech, Inc. (2696.HK) announces that recently, PT Kalbio Global Medika, the subsidiary of Henlius’ partner PT Kalbe Genexine Biologics (KGbio), has received the relevant registration certificates issued by Indonesia’s National Agency for Drug and Food Control (Indonesian: Badan Pengawas Obat and Makanan, the “BPOM”) for the approval of Henlius’ self-developed and manufactured anti-PD-1 mAb HANSIZHUANG (serplulimab) in Indonesia under the trade name Zerpidio® for the treatment of extensive stage small cell lung cancer (ES-SCLC). This is the first time HANSIZHUANG has been successfully approved for marketing in an overseas market, and it has become the first China anti-PD-1 mAb successfully approved for marketing in Southeast Asia. Currently, Henlius is joining hands with KGbio for the development and commercialisation in 22 countries, and the approval is expected to bring HANSIZHUANG to more patients in Indonesia. Lung cancer (LC) is one of the most ...
ROCKVILLE, Md. and SUZHOU, China, Dec 20, 2023 — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, and Sanegene Bio USA Inc. (SanegeneBio) announce that they have entered into a collaboration agreement to co-develop SGB-3908, an siRNA drug candidate targeting angiotensinogen (AGT) for the treatment of hypertension. Innovent also obtains an exclusive option to license in the future development, manufacturing and commercialization rights of SGB-3908. SGB-3908 is an IND-enabling stage siRNA drug developed based on SanegeneBio’s proprietary LEAD™ (Ligand and Enhancer Assisted Delivery) platform. Under the terms of the agreement, both parties will be jointly responsible for the development of SGB-3908 to certain stage. Innovent will receive an exclusive option to pay different option exercise fees to obtain the exclusive development, manufacturing, and commercialization license of SGB-3908 in ...
Pharmaceutical Executive Editorial Staff Adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Merck’s Keytruda lowered the risk of recurrence or death by 49% compared with Keytruda monotherapy. Findings from the KEYNOTE-942/mRNA-4157-P201 clinical trial show that Moderna’s investigational individualized neoantigen therapy plus Merck’s Keytruda (pembrolizumab) lowered the risk of death or relapse by nearly half in patients with resected high-risk melanoma (stage III/IV) following complete resection. A planned analysis of the Phase IIb randomized trial found that at a median follow-up of approximately three years, adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Keytruda continued to show a clinically meaningful improvement in recurrence-free survival (RFS) by lowering the risk of recurrence or death by 49% compared with Keytruda monotherapy. “As we continue to follow participants in the KEYNOTE-942/mRNA-4157-P201 study, we are excited to see such a robust clinical benefit with mRNA-4157 (V940) as adjuvant treatment in combination with Keytruda ...
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