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CARsgen Therapeutics’ Suspended CAR-T Therapies Get FDA Green Light to Resume
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The US Food and Drug Administration (FDA) has removed the suspension on clinical studies for three chimeric antigen receptor (CAR)-T therapies developed by CARsgen Therapeutics Holdings Ltd (HKG: 2171), according to the company’s statement to the Hong Kong Stock Exchange. The therapies include CT053 (zevorcabtagene autoleucel), a BCMA-targeted CAR-T therapy…
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AIM Vaccine Submits Market Filing for 13-Valent Pneumococcal Conjugate Vaccine in China
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the submission of a market filing for its in-house developed 13-valent pneumococcal conjugate vaccine to the National Medical Products Administration (NMPA). Streptococcus pneumoniae disease is a high-priority target for vaccine prevention efforts. The 13-valent pneumococcal conjugate vaccine is designed for infants…
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Eisai and Biogen Complete BLA Submission for Alzheimer’s Drug Leqembi to FDA
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Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have jointly announced the completion of a rolling submission of a Biologics License Application (BLA) for their co-developed Alzheimer’s disease drug Leqembi (lecanemab) to the U.S. Food and Drug Administration (FDA). The submission seeks approval for Leqembi as a subcutaneous…
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Jenscare Scientific’s LuX-Valve Plus Shows Positive One-Year Results in TRAVEL II Study
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Ningbo-based structural heart disease device manufacturer Jenscare Scientific Co., Ltd (HKG: 9877) has announced the one-year follow-up results from the multi-center TRAVEL II study for its transjugular tricuspid valve replacement product, LuX-Valve Plus, at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 annual meeting in Washington. The TRAVEL II study, which assesses…
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Biogen Reports Q3 2024 Sales Dip, Raises Full-Year Guidance
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US biotechnology company Biogen Inc. (NASDAQ: BIIB) reported global sales of USD 2.466 billion for the third quarter of 2024, marking a 3% year-on-year (YOY) decrease in operational terms. Despite this, Biogen increased its full-year 2024 financial guidance, with non-GAAP diluted EPS now expected to range between USD 16.10 and…
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Tasly Pharmaceuticals Gets FDA Approval for Acute Ischemic Stroke Cell Therapy Clinical Study
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China-based Tasly Pharmaceuticals (SHA: 600535) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its investigational therapy, NR-20201. This allogeneic adipose-derived mesenchymal stem cell therapy is in development for the treatment of acute ischemic stroke. Preclinical study results…
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HutchMed to Receive $20 Million Milestone Payment from Takeda for Fruzaqla Sales
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China-based HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) is poised to receive a USD 20 million milestone payment from its Japanese partner Takeda (TYO: 4502; NYSE: TAK), following the achievement of over USD 200 million in sales of Fruzaqla (fruquintinib) for metastatic colorectal cancer (CRC). Fruquintinib, a selective oral inhibitor…
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Zhejiang Huahai Pharmaceutical Gets New Zealand Approval for Asthma Bispecific Antibody Trial
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Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced receiving clinical trial approval in New Zealand for its HB0056, a bispecific antibody (BsAb) targeting thymic stromal lymphopoietin (TSLP) and interleukin-11 (IL-11), clearing the way for the drug to enter Phase I clinical studies for asthma treatment. HB0056 is the world’s…
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Youcare Pharmaceutical Group Gets NMPA Approval for YKYY015 Phase I Study
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China-based Youcare Pharmaceutical Group (SHA: 688658) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its investigational drug YKYY015, targeting primary hypercholesterolemia or mixed hyperlipidemia characterized by elevated LDL-C levels. YKYY015, an siRNA drug, is distinctive for…
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Innovent Biologics Reports Q3 2024 Sales Exceeding RMB 2.3 Billion, Up 40% YOY
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China-based Innovent Biologics Inc., (HKG: 1801) has announced product sales exceeding RMB 2.3 billion (USD 323 million) for the third quarter of 2024, marking a 40% year-on-year (YOY) increase. The company’s competitive edge in China is attributed to its product indication expansion, extensive coverage on the National Reimbursement Drug List,…
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CStone Pharmaceuticals’ Sugemalimab Wins UK Approval for NSCLC Treatment
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China-based CStone Pharmaceuticals (HKG: 2616) has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for sugemalimab, in combination with platinum-based chemotherapy, as a first-line treatment for adult patients with metastatic non-small cell lung cancer (NSCLC) without EGFR-sensitive mutations or ALK, ROS1, RET genomic alterations. This…
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Dizal Pharmaceutical’s Q3 2024 Revenues Soar 236% YOY on Strong Product Sales
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has released its financial report for the third quarter of 2024, announcing revenues of RMB 135 million (USD 18.94 million) for the quarter, marking a 236.39% year-on-year (YOY) increase. Revenues for the first three quarters reached RMB 338 million (USD 47.43 million), reflecting…
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Amgen Reports Q3 2024 Revenues of USD 8.5 Billion, Marking a 23% YOY Increase
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US biotechnology company Amgen (NASDAQ: AMGN) has announced its financial results for the third quarter of 2024, with revenues reaching USD 8.5 billion, an increase of 23% year-on-year (YOY). Product sales saw a 24% increase, with an 8% growth when excluding sales from the Horizon Therapeutics (Horizon) acquisition. In the…
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HOB Biotech Group and Sino Biopharmaceutical Ltd Form Strategic Partnership in Allergy Treatments
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Jiangsu-based HOB Biotech Group Corp., Ltd (SHA: 688656) has announced a strategic cooperation agreement with Sino Biopharmaceutical Ltd (HKG: 1177), along with controlling shareholder HOB Biotech Group Limited and John Li, chairman and general manager of HOB. The collaboration aims to explore and cooperate in the research and development, production,…
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Sandoz Q3 2024 Sales Boosted by Biosimilars and Generics, Up 12% YOY
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Switzerland-based Sandoz (SWX: SDZ) has published its financial statements for the third quarter of 2024, reporting sales of USD 2.6 billion, reflecting a 12% year-on-year (YOY) increase in constant currency terms. Chemical generics contributed USD 1.854 billion in sales, marking a 4% YOY increase, while biosimilars saw a significant surge…
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Junshi Biosciences Reports Q3 2024 Financials with Revenue Growth and Narrowed Losses
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Junshi Biosciences (HKG: 1877; SHA: 688180) has released its financial results for the third quarter of 2024, reporting revenues of RMB 1.271 billion (USD 178.36 million) for the first three quarters, marking a 28.87% year-on-year (YOY) increase, and a net loss of RMB 927 million (USD 130 million). The third…
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Chipsscreen Biosciences and Zhejiang Hisun Pharmaceutical End Strategic Partnership for Chiglitazar Launch
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China-based Chipscreen Biosciences Co., Ltd (SHA: 688321) has reached an agreement with Zhejiang Hisun Pharmaceutical Co., Ltd (SHA: 600267) to terminate their strategic partnership, which was initially formed in December 2020 to support the launch of the hypoglycemic drug chiglitazar (Bilessglu) for type 2 diabetes in 19 provinces, including Henan,…
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Eli Lilly Reports 20% YOY Revenue Growth in Q3 2024 Driven by Mounjaro and Zepbound
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US pharmaceutical giant Eli Lilly and Company (NYSE: LLY) has reported its financial results for the third quarter of 2024, with total revenues increasing by 20% year-on-year (YOY) to USD 11.439 billion. The growth was propelled by volume increases from Mounjaro and Zepbound, as well as higher realized prices. In…
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AstraZeneca China President Leon Wang Involved in Chinese Investigation Amid Industry Probes
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Leon Wang, Executive Vice President International and AstraZeneca (AZ, NASDAQ: AZN) China President, is cooperating with an investigation by Chinese authorities, as stated by the UK pharmaceutical major. During this period, AstraZeneca China General Manager Lai Minglong will ensure business continuity. This development follows a series of media reports about…
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AbbVie’s Allergan Aesthetics Launches Juvéderm VOLUX in China
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Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has announced the official market launch of its Juvéderm VOLUX dermal filler product in China. Juvéderm VOLUX is a hyaluronic acid-based product specifically designed for contouring the lower jaw area. It is used for injection onto the facial periosteum to enhance the…
