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Inventiva and Chia Tai Tianqing File Clinical Trial for Lanifibranor with CDE
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France-based Inventiva S.A. and China’s Chia Tai Tianqing have filed a clinical trial application with the Center for Drug Evaluation (CDE) for their Category 1 drug, lanifibranor. The application has been accepted for review. Lanifibranor is an oral peroxisome proliferator-activated receptor (PPAR) agonist designed to treat non-alcoholic fatty liver disease…
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Simcere Pharmaceutical Initiates Clinical Study for Bispecific Antibody SIM0237 in Advanced Tumors
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the first patient in (FPI) a clinical study for its bispecific antibody (BsAb) SIM0237, targeting PD-L1 and IL-15 in advanced solid tumors. The global multi-center, open-label Phase I study is designed to assess the safety, efficacy, and pharmacokinetics/pharmacodynamics of the drug. The…
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AusperBio and Asymchem Form Strategic Partnership for New Drug R&D and Services
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China-based firms AusperBio and Asymchem (SHE: 002821, HKG: 6821) have entered into a strategic partnership to enhance their collaboration in new drug R&D technical services, drug administration and regulation consultation, brand linkage communication, and more. This partnership builds on their existing collaboration, which has already yielded significant results in the…
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Bio-Thera Solutions Initiates Phase I Study for Trop2-Targeting ADC BAT8008
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China-based Bio-Thera Solutions, Ltd (SHA: 688177) has announced the first patient dosing in a multi-center, open Phase I study to assess the safety, tolerability, and preliminary efficacy of BAT8008, an antibody-drug conjugate (ADC) targeting Trop2 in advanced solid tumors. The study will also help determine the recommended Phase II dosage.…
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Astellas and Seagen File for NMPA Approval of Enfortumab Vedotin for Urothelial Carcinoma
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Japan-based Astellas Pharma Inc. (TYO: 4503) and US biotech Seagen Inc. (Nasdaq: SGEN) have announced the completion of a market approval filing with the National Medical Products Administration (NMPA) in China for the antibody drug conjugate (ADC) enfortumab vedotin, marketed as Padcev in the US. The filing seeks approval for…
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HealiRNA Secures RMB 100 Million in Pre-Series A Funding for Nucleic Acid Drug Development
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China-based nucleic acid drug specialist Suzhou HealiRNA has reportedly raised over RMB 100 million (USD 14.35 million) in a pre-Series A financing round. The round was led by MING Bioventures, with additional investments from Shunwei Capital, China-Singapore Suzhou Industrial Park Private Equity Management Co., Ltd, and existing investor Sequoia Capital…
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InnoCare Pharma Initiates Clinical Study for BCL2 Inhibitor ICP-248 in China
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced the first subject dosing in a clinical study for its B-cell lymphoma-2 (BCL2) inhibitor, ICP-248. The study was approved in China in September last year. This marks a significant milestone in the development of the drug, which is designed to treat…
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Thederma Pharmaceuticals Raises RMB 100 Million for AhR-Targeted Autoimmune Therapies
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China-based Shanghai Thederma Pharmaceuticals Co., Ltd has reportedly raised RMB 100 million (USD 14.35 million) in a Series A financing round, led by Bainuo Capital. Existing investor Hankang Capital also participated in the round. The proceeds will be used to support research and development and clinical studies for multiple autoimmune…
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Xinrui Medtech Secures Pre-Series A Funding for Cardiovascular Device Development
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Xinrui Medtech, a cardiovascular device maker based in Suzhou, has reportedly raised “tens of millions” of renminbi in a pre-Series A financing round. The round was led by HM Capital, with additional funding from Northern Lights Venture Capital. The proceeds will be used to support clinical studies, new product research…
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Haihe Pharma’s Glumetinib Gains Conditional NMPA Approval for NSCLC
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Shanghai Haihe Pharmaceutical Co., Ltd’s Category 1 product, glumetinib, has received conditional market approval from the National Medical Products Administration (NMPA). This small-molecule MET inhibitor is now approved for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET14 exon hopping, marking a significant advancement in…
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AmVision Biotech Secures Nearly $14.34M in Series A+ for Ophthalmology Innovations
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AmVision Biotech, a leading ophthalmology device platform company based in Guangzhou, has reportedly secured close to RMB 100 million (USD 14.34 million) in a Series A+ financing round. The round was led by Green Pine Capital Partners, with participation from ZDVC and existing investor HM Capital, among others. This significant…
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JW Therapeutics Launches Carteyva Clinical Study for High-Risk Lymphoma
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China-based JW Therapeutics (HKG: 2126) has announced the initiation of a clinical study for its Carteyva (relmacabtagene autoleucel injection) in the treatment of first-line high-risk large B-cell lymphoma. A significant milestone was reached with the completion of reinfusion therapy for the first patient. Previous Study Outcomes and Current Trial DesignThe…
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Chongqing Evaheart Secures Near $100M in Series A for Heart Failure Platform
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Chongqing Evaheart Medical Device Co., Ltd has reportedly secured close to USD 100 million in a Series A financing round. The round was led by Sinovac, with significant contributions from Taiping (Shenzhen) Healthcare Industry Private Equity Investment Fund and Vivo Capital. The funds raised will be directed towards the development…
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Biocytogen and Janssen Sign Licensing Agreement for RenLite Platform
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Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315) has announced the signing of a non-exclusive licensing agreement with Janssen Biotech Inc., a subsidiary of Johnson & Johnson (J&J, NYSE: JNJ). The agreement, facilitated by Johnson & Johnson Innovation LLC, grants Janssen and its affiliates a non-exclusive worldwide license to utilize Biocytogen’s…
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Haihe Pharma’s Glumetinib Receives Conditional Approval for NSCLC Treatment
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Shanghai Haihe Pharmaceutical Co., Ltd’s Category 1 product, glumetinib, has obtained conditional market approval from the National Medical Products Administration (NMPA). The small-molecule MET inhibitor is now approved for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET14 exon hopping. Development and Clinical FindingsGlumetinib, co-developed…
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AmVision Biotech Secures RMB 100 Million in Series A+ Financing for Ophthalmology Innovation
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AmVision Biotech, an ophthalmology device platform company based in Guangzhou, has reportedly raised close to RMB 100 million (USD 14.34 million) in a Series A+ financing round. The funding was led by Green Pine Capital Partners, with contributions from ZDVC and existing investor HM Capital, among others. This investment will…
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JW Therapeutics Initiates Clinical Study for Carteyva in First-Line High-Risk Large B-Cell Lymphoma
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China-based JW Therapeutics (HKG: 2126) has announced the initiation of a clinical study for its Carteyva (relmacabtagene autoleucel injection) in first-line high-risk large B-cell lymphoma. The first patient has already completed reinfusion therapy, marking a significant step in the study’s progress. Previous Study ResultsThe pivotal RELIANCE study previously demonstrated that…
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Evaheart Med Raises USD 100 Million in Series A Funding Led by Sinovac
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Chongqing Evaheart Medical Device Co., Ltd has reportedly raised close to USD 100 million in a Series A financing round led by Sinovac, with contributions from Taiping (Shenzhen) Healthcare Industry Private Equity Investment Fund and Vivo Capital. The proceeds will be used to develop and construct a comprehensive heart failure…
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HQ Pharma and Shanxi HCXF Partner to Expand Oral Soluble Film R&D and Production
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China-based firms HQ Pharma and Shanxi HCXF Pharmaceutical Co., Ltd have agreed to jointly expand their one-stop oral soluble film research and development (R&D) and production services. The collaboration aims to enhance their capabilities in this innovative drug delivery system, with no financial details disclosed. Advantages of Oral Soluble FilmsOral…
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Biocytogen and Janssen Sign Licensing Agreement for RenLite Platform
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Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315) has announced the signing of a non-exclusive licensing agreement with Janssen Biotech Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ). The agreement grants Janssen and its affiliates a non-exclusive worldwide license to use Biocytogen’s proprietary RenLite platform and…
