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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…
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Simcere’s SIM0237 Begins Clinical Study for PD-L1 and IL-15 Targeting Bispecific Antibody
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the first patient in (FPI) a clinical study for its SIM0237, a bispecific antibody (BsAb) 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.…
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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 under the brand name Padcev in the US. The filing…
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HuiLiao Biomedical Raises RMB 100 Million in Pre-Series A Round for mRNA Development
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China-based nucleic acid drug specialist Suzhou HuiLiao Biomedical Technology Co., Ltd 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 participation from Shunwei Capital, China-Singapore Suzhou Industrial Park Private Equity Management Co., Ltd, and existing…
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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, approved in China in September last year, marks a significant step in the development of this novel therapy. Drug Profile and IndicationsICP-248 is a…
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Thederma Pharmaceuticals Raises RMB 100 Million for AhR-Targeted 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. The round was led by Bainuo Capital, with participation from existing investor Hankang Capital. The proceeds will be used to support research and development and clinical studies for multiple…
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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 a contribution from Northern Lights Venture Capital. The proceeds will be used to support clinical studies, new product research…
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Lifetech Scientific’s IBS Angel Stent Receives CE MDR Certification in EU
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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 product in the EU. The first-in-class product is designed for minimally…
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Olipharma Raises Funds in Pre-Series A+ Round to Expand Manufacturing Facilities
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Olipharma, a small nucleic acid drug Contract Development and Manufacturing Organization (CDMO) based in Suzhou, has reportedly raised an undisclosed amount of money in a Pre-Series A+ financing round. The investment was led by Tsing Song Capital and Addor Capital, with participation from existing investor Matrix Partners. The proceeds will…
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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…
