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On December 24, 2024, China Isotope & Radiation Corporation (HKG: 1763) announced that its subsidiary, HTA Co., Ltd., has received approval from the National Medical Products Administration (NMPA) to initiate clinical trials for their Class 1 innovative drug, [18F] Piramide Injection. [18F] Piramide: A PET Imaging Agent for Enhanced Melanoma…
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced receiving official approval from the US Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) of its biosimilar version of Denmark firm Novo Nordisk’s (NYSE: NVO) Victoza (liraglutide). Liraglutide: A Crucial Treatment for DiabetesLiraglutide, an analog of human…
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China’s Shanxi C&Y Pharmaceutical Group Co., Ltd (SHE: 300254) has announced the initiation of a clinical study for its generic version of UK firm Shield TX(UK)Limited’s iron supplement ferric maltol, following approval from the National Medical Products Administration (NMPA). The study aims to evaluate the drug’s efficacy in treating iron…
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China-based Clinical Research Organization (CRO) Boji Medical Technology Co., Ltd. (SHE: 300404) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for TBA, a novel treatment for drug-resistant pulmonary tuberculosis. TBA: A New Approach to Combating Drug-Resistant TuberculosisThe Category 1 chemical drug, co-developed…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving separate clinical trial approvals from the National Medical Products Administration (NMPA). One trial will test the combination of HRS-4357 with ADT and a novel androgen receptor pathway inhibitor for prostate cancer. The other trial will assess SHR-4602 in combination with…
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The China’s Center for Drug Evaluation (CDE) website has indicated that China-based Sichuan Biokin Pharmaceutical Co., Ltd’s (SHA: 688506) BL-M08D1 and CSPC Pharmaceutical Group Ltd’s (HKG: 1093) SYS6010 are on track to obtain Breakthrough Therapy Designations (BTDs) from the agency. These designations are for the treatment of recurrent small cell…
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The China’s Center for Drug Evaluation (CDE) website has indicated that several drugs, including German giant Boehringer Ingelheim’s (BI) zongertinib, Visirna Therapeutics’ plozasiran, Chia Tai Tianqing’s anlotinib, and HutchMed (China) Ltd’s (HKG: 0013, NASDAQ: HCM) Orpathys (savolitinib), are on course to obtain priority review statuses. Boehringer Ingelheim’s Zongertinib for HER2-Mutated…
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced receiving clinical approval from the National Medical Products Administration (NMPA) to test its Category 1 biologic product, ZG005, in combination with gecaicitinib for the treatment of advanced solid tumors and recurrent refractory lymphomas in China. ZG005: A Pioneering Bispecific Antibody for…
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On December 24, the Western Chongqing Southern Sichuan Precision Medicine Center Digital Information Platform was inaugurated in Rongchang District of Chongqing. The center, guided by the local health commission bureau and implemented by China-based Zhejiang Dian Diagnostics Co., Ltd (SHE: 300244), aims to optimize and integrate medical laboratory resources within…
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China’s Center for Drug Evaluation (CDE) website has indicated that a market filing by local firm ProteLight Pharma for its Category 1 product peceleganan (PL-5) has been accepted for review by the bureau. This development follows a licensing deal in January 2023, through which Chia Tai Tianqing obtained the exclusive…
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced a clinical study and supply agreement with Suzhou ForLong Biotechnology Co., Ltd, a collaboration aimed at exploring the potential of Innovent’s sintilimab combined with ForLong’s FL115 in treating advanced solid tumors. Sintilimab and FL115: A Promising Combination for Cancer TreatmentSintilimab, a PD-1…
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Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that its macromolecular drug-focused subsidiary, Shanghai Huaota Biopharmaceutical Co., Ltd., has successfully raised RMB 200 million (USD 27.4 million) through a new issuance of 20 million shares. The shares were exclusively subscribed by Linhai Haijing Venture Capital. This transaction has increased…
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US pharmaceutical major Bristol-Myers Squibb (BMS; NYSE: BMY) has announced positive results from the pivotal Phase III POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055) studies for its drug Sotyktu (deucravacitinib). These studies assessed the efficacy and safety of Sotyktu in adults with active psoriatic arthritis (PsA). Achievement of Primary and…
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China-based Bio-Thera Solutions (SHA: 688177) has announced a licensing agreement with Tabuk Pharmaceutical Manufacturing Company, a fully-owned subsidiary of Astra Industrial Group and a leading pharmaceutical company in the Middle East and North Africa (MENA) region. The agreement pertains to BAT2206, Bio-Thera’s biosimilar version of Roche’s (SWX: ROG) Stelara (Ustekinumab).…
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UK-based Achilles Therapeutics plc has announced a landmark deal worth USD 12 billion with AstraZeneca (AZ, NASDAQ: AZN), which involves the transfer of the UK company’s commercial license of data and samples from the TRACERx Non-Small Cell Lung Cancer (NSCLC) study. TRACERx Study: A Pioneering Effort in Tumor Evolution ResearchThe…
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US-based Nuvation Bio Inc. (NYSE: NUVB) has announced that the New Drug Application (NDA) for its investigational next-generation ROS1 tyrosine kinase inhibitor (TKI), taletrectinib, has been accepted for review by the US Food and Drug Administration (FDA) with priority review status. The filing seeks approval for taletrectinib to treat advanced…
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced the first Chinese patient dosing in the global, multi-center Phase III ELAINE-3 study for its investigational drug lasofoxifene. The study focuses on pre/post menopausal women and men with estrogen receptor positive (ER+), human epidermal growth…
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China-based RaysightMed Co., Ltd has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its next-generation FFR imaging product, AngioQFA 100, a revolutionary coronary artery function measurement system. Advanced Fusion Technology for Comprehensive AssessmentThe AngioQFA 100 system employs a sophisticated fusion of artificial intelligence…
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China-based uBriGene, a contract development and manufacturing organization (CDMO) focused on advanced therapy medicinal products (ATMPs), has announced the completion of its Pre-Series D financing round, raising close to RMB 200 million (USD 27.4 million). This funding round comes on the heels of the Series C+ financing round completed in…
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China-based Contract Development and Manufacturing Organization (CDMO) WuXi AppTec Co., Ltd (SHA: 603259) has announced that its unit, WuXi ATU, will sell all stakes in WuXi Advanced Therapies Inc. and Oxford Genetics Limited, its US and UK operation entities respectively, to Altaris LLC. Altaris LLC is a US-headquartered equity investment…