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Vcanbio’s VUM02 Gains CDE Review for Liver Failure and ARDS Clinical Trials
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Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that two additional clinical trial filings for its VUM02 (human umbilical cord-derived mesenchymal stem cells) have been accepted for review by the Center for Drug Evaluation (CDE). The Chinese firm is seeking clinical approval for this Category 1 therapeutic…
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Luye Pharma’s Biosimilar BA9101 Completes Phase III Study Enrollment with Ocumension
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China-based Luye Pharma Group’s (HKG: 2186) controlling subsidiary, Shandong Boan Biotechnology Co., Ltd, has completed the enrollment of all subjects in a Phase III safety and efficacy comparison study for its in-house developed ophthalmology product BA9101, a biosimilar version of Bayer’s Eylea (aflibercept). The study is being jointly conducted by…
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Immunophage Biotech Raises RMB 200 Million in Series B1 Financing for Clinical Trials
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Nanjing-based Immunophage Biotech Co., Ltd reportedly raised close to RMB 200 million (USD 29.1 million) in the first phase of a Series B1 financing round, led by ZBJL Capital and supported by debt financing. The funds will be used to advance Phase II clinical studies for first-tier products and Phase…
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Akeso Biopharma Enrolls First Subject in Phase III Study of Cadonilimab for Gastric Cancer
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China-based Akeso Biopharma (HKG: 9926) has announced the enrollment of the first subject in a pivotal Phase III study for its innovative bispecific antibody (BsAb), cadonilimab (AK104). The study will assess cadonilimab in combination with chemotherapy for first-line treatment of unresectable locally advanced or metastatic gastric cancer/gastroesophageal junction adenocarcinoma (GC/GEJC).…
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CSPC Pharmaceutical’s PD-1 Monoclonal Antibody Enlangsubai Completes NMPA Market Approval Filing
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced the completion of a market approval filing with the National Medical Products Administration (NMPA) in China for its programmed-death 1 (PD-1) monoclonal antibody (mAb), Enlangsubai. The targeted indication is recurrent or metastatic cervical cancer with positive PD-L1 expression that has failed…
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Pasteur Institute Suspends Joint Venture with Chinese Academy of Sciences
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France’s Pasteur Institute has announced its decision to suspend its joint-venture (JV) partnership with the Beijing-based Chinese Academy of Sciences (CAS), known as the Institute Pasteur of Shanghai. According to a statement, the Pasteur Institute will no longer co-lead the JV and is not participating in any of its activities.…
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Boston Scientific Launches REPLACE Study for FARAPULSE PFA System in China
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US-based medical technology major Boston Scientific Corporation (NYSE: BSX) has announced the initiation of the real-world REPLACE study for its pulsed field ablation (PFA) system, FARAPULSE, in Chinese patients with paroxysmal atrial fibrillation (PAF). The study is being conducted at the Boao Lecheng Medical Tourism Pilot Zone of Hainan Province,…
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Chipscreen’s Epidaza Receives TFDA Approval for Breast Cancer Treatment in Taiwan
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Shenzhen Chipscreen Pharmaceutical Co., Ltd’s partner, GNT Biotech & Medicals Corporation, has announced that it has received market approval from the Taiwan Food and Drug Administration (TFDA) for Epidaza (chidamide, Kepida in TW). This innovative class 1-selective oral histone deacetylase inhibitor was originally discovered by Chipscreen. Indication and Target Patient…
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Silicon Valley Bank Collapse Impacts Tech and Biotech Sectors Globally
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The tech and biotech sectors are grappling with the implications of the collapse of US-based Silicon Valley Bank (SVB; Nasdaq: SIVB), which specialized in working with the tech and biopharma venture capital sectors. The bank was seized by the US government’s Federal Deposit Insurance Corporation (FDIC) on Friday, March 10,…
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Allorion Therapeutics Raises USD 50 Million in Series B Financing to Advance Drug Development
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Allorion Therapeutics, a next-generation precision medicine small molecule drug developer based in Guangzhou, reportedly raised USD 50 million in a Series B financing round. The round was led by INCE Capital and Qiming Venture Partners, with contributions from TF Capital, LongRiver Investments, 3SBio, Octagon Capital, and Lichen Private Equity Fund.…
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XtalPi and Chia Tai Tianqing Achieve Phase II Milestone in Cancer Drug Development
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Sino-US artificial intelligence (AI) firm XtalPi Inc. has partnered with China’s Chia Tai Tianqing to reach the Phase II milestone in their small molecule cancer drug research and development (R&D) program. The collaboration leveraged Chia Tai Tianqing’s in-house innovative drug innovation platform and XtalPi’s AI drug discovery platform to achieve…
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Overland Pharmaceuticals Partners with GoBroad Healthcare to Strengthen Cell Therapy Research
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China-based firm Overland Pharmaceuticals has entered into a strategic partnership with GoBroad Healthcare Group to enhance Overland’s translational and clinical study capabilities in the cell therapy field. The collaboration aims to strengthen Overland’s development efforts in universal chimeric antigen receptor (CAR)-T cell therapy. No financial details were disclosed. Scope of…
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Haihe Pharmaceutical Initiates Global Phase I Clinical Study for BET-BD2 Inhibitor HH3806
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Shanghai Haihe Pharmaceutical Co., Ltd has announced the first patient dosing of a global multi-center Phase I clinical study for its in-house developed BET-BD2 inhibitor, HH3806, in Australia. This marks a significant milestone in the development of the drug, which targets the bromo and extra terminal (BET) binding domain 2…
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CanSino Biologics Initiates Phase Ib Study for Innovative Protein-Based Pneumococcal Vaccine
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China-based vaccines specialist CanSino Biologics Inc. has announced the initiation and first subject enrollment of a Phase Ib clinical study for its in-house developed protein-based pneumococcal vaccine (PBPV). This marks a significant step forward in the development of a globally innovative vaccine. Innovation and AdvantagesCanSino’s PBPV represents the third generation…
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Zenshine Pharmaceuticals Raises RMB 100 Million in Series B Financing for Drug Development
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China-based small molecule drug developer Nanjing Zenshine Pharmaceuticals Co., Ltd reportedly raised over RMB 100 million in a Series B financing round. The round was led by Hankang Capital and included participation from Cybernaut, Yangzijiang Funds, Ennovation Ventures, and Matrix Partners China. The proceeds will be used to enhance the…
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Livzon Pharmaceutical Secures Exclusive Rights to Onconic’s GERD Treatment Zastaprazan
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China-based Livzon Pharmaceutical Group Inc. (HKG: 1513) has announced a licensing agreement with South Korean firm Onconic Therapeutics. Under the agreement, Livzon has secured exclusive development, licensing, manufacturing, and commercialization rights to Onconic’s Zastaprazan, a gastroesophageal reflux disease (GERD) treatment candidate, in Greater China, including the Chinese mainland, Hong Kong,…
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CStone’s Ayvakit Shows Significant Improvements in ISM at AAAAI Meeting
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China-based CStone Pharmaceuticals (HKG: 2616) announced that its US partner, Blueprint Medicines, published detailed data from the PIONEER regulatory study for Ayvakit (avapritinib) at the American Academy of Allergy, Asthma, and Immunology (AAAAI) annual meeting this year. Ayvakit is a tyrosine kinase inhibitor used to treat gastrointestinal stromal tumors (GIST)…
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Lifetech’s IBS Angel Stent System Gains EU CE MDR Certification
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China-based Lifetech Scientific Corporation (HKG: 1302) has announced that it has received CE MDR certification in the European Union (EU) for its in-house developed IBS Angel iron-based absorbable stent system. This marks the world’s first commercialization of such a stent system in the EU, targeting the minimally invasive surgical treatment…
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Olipharma Secures Funding for Manufacturing Expansion in Pre-Series A+ Round
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Olipharma, a Contract Development and Manufacturing Organization (CDMO) specializing in small nucleic acid drugs and based in Suzhou, has reportedly secured an undisclosed amount of funding in a Pre-Series A+ financing round. The round saw participation from Tsing Song Capital, Addor Capital, and existing investor Matrix Partners. The proceeds are…
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Inventiva and Chia Tai Tianqing’s Lanifibranor Advances with CDE Filing
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France-based Inventiva S.A. and China’s Chia Tai Tianqing have successfully filed a clinical trial application with the Center for Drug Evaluation (CDE) for the Category 1 drug lanifibranor. The submission has been accepted for review, marking a significant step forward in the development of this promising treatment. Licensing and Regulatory…
