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RemeGen’s RC48 Gains NMPA Approval for Phase II Study in Bladder Cancer
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China – based biopharmaceutical company RemeGen Ltd (HKG: 9995) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II study of its antibody – drug conjugate (ADC) candidate RC48 (disitamab vedotin). The study will assess the efficacy and safety of RC48…
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Apeloa and Simcere Partner for CDMO Services and R&D Collaboration
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China – based contract development and manufacturing organization (CDMO) Apeloa Pharmaceutical Co., Ltd (SHE: 000739) has announced a partnership agreement with compatriot firm Simcere Pharmaceutical Group (HKG: 2096). The collaboration aims to enhance the research and development (R&D) and manufacturing capabilities of both companies through strategic alignment. Details of the…
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Sino Biopharmaceutical’s CTTQ Partners with ProteLight for Antibacterial Peptide PL-5
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China – based Sino Biopharmaceutical Ltd (HKG: 1177) has announced that its subsidiary Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd (CTTQ) has entered into an exclusive commercial cooperation agreement with compatriot firm Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd. Under the terms of the agreement, CTTQ will be responsible for…
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Inscinstech Raises RMB 150 Million in Series A+, B, and B+ Rounds
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Inscinstech Inc., a leading specialist in biological separation technology based in Suzhou, China, has successfully raised a total of RMB 150 million (USD 21.73 million) across its Series A+, B, and B+ financing rounds. The funding rounds were led by ESCO Lifesciences Group, Luxin Venture Capital, and Qiming Venture Partners,…
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Everest Medicines Outlines Strategic Plans for Expansion and Growth
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China – based biopharmaceutical company Everest Medicines (HKG: 1952) has announced its strategic plans for the next two years and beyond as it progresses toward becoming a fully – integrated biopharmaceutical company. The company aims to develop capabilities across the full biotechnology value chain, including in – house discovery, in…
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Zai Lab Appoints Dr. Rafael Amado as President of Cancer R&D
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Chinese biopharmaceutical company Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has announced the appointment of Dr. Rafael G. Amado as President and Global Head of Cancer Research and Development (R&D), effective December 30, 2022. Dr. Amado will join the company’s management committee as a core member, reporting directly to Dr.…
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Jiangxi Jemincare Gains FDA Approval for Clinical Trial of JYB1907 in Solid Tumors
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China – based Jiangxi Jemincare Group has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its Category 1 drug JYB1907. The monoclonal antibody (mAb) targets glycoprotein A dominant repeat (GARP) and transforming growth factor – β1 (TGF –…
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Mabwell Receives NMPA Approval for Clinical Trial of 9MW3011 in Rare Diseases
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China – based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its Category 1 drug candidate 9MW3011 for the treatment of β – thalassemia and polycythemia vera. The drug, which already…
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Staidson’s Anti-C5a Monoclonal Antibody STSA-1002 Accepted for NMPA Review
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China-based Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204) has announced that the clinical trial filing for its injectable STSA-1002, an anti-human complement protein C5a (hC5a) monoclonal antibody (mAb) for use in acute respiratory distress syndrome (ARDS), has been accepted for review by the National Medical Products Administration (NMPA). About ARDS…
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Guangdong Raynovent Biotech Secures RMB 370 Million in Series C Financing
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Guangdong Raynovent Biotech Co., Ltd, a controlling subsidiary of China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), has reportedly raised RMB 370 million (USD 53.72 million) in a Series C financing round. The round was co-led by Yide Private Equity Investment Fund Management (Guangzhou) Co., Ltd and Efung Capital, with…
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Hengrui Pharmaceuticals Appoints Dr. Jiang Ningjun as Deputy General Manager and CSO
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced the appointment of Dr. “Frank” Jiang Ningjun as its deputy general manager and chief strategy officer (CSO). Dr. Jiang will be tasked with overseeing clinical studies and driving business expansion. Moving forward, Sun Piaoyang, Zhang Lianshan, and Dr. Jiang Ningjun will form…
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Junshi Biosciences’ CGRP Monoclonal Antibody JS010 Accepted for NMPA Review
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that the clinical trial filing for JS010, its in-house developed CGRP monoclonal antibody drug candidate for treating migraine, has been accepted for review by the National Medical Products Administration (NMPA) in China. About CGRP and JS010CGRP is a neuropeptide composed of…
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BeiGene’s Tislelizumab Receives NMPA Review for First-Line HCC Indication
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BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has revealed that a supplementary Biologic License Application (sBLA) for its programmed death-1 (PD-1) inhibitor tislelizumab has been accepted for review by the National Medical Products Administration (NMPA). The latest prospective indication is for the drug’s use in first-line unresectable or metastatic hepatocellular…
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Immunohead Biotech Raises RMB 200 Million in Series A+ Financing Round
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Immunohead Biotechnology Co., Ltd, a cell therapy developer based in Suzhou, has reportedly raised close to RMB 200 million (USD 28.89 million) in a Series A+ financing round. The round was led by SDIC Venture Capital, with participation from the Bio-Town Equity Investment Fund. The proceeds will be used to…
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Biocytogen and Hansoh Enter Antibody Collaboration and Licensing Agreement
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China-based Biocytogen Pharmaceuticals (Beijing) Co., Ltd has announced an antibody collaboration, assignment, and exclusive license agreement with compatriot firm Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692). Under the agreement, Biocytogen will provide a license to Hansoh to use selected fully human antibody molecules against a designated target for global development,…
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CStone Pharmaceuticals Achieves Primary Endpoint in GEMSTONE-304 Study for Sugemalimab
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China-based CStone Pharmaceuticals (HKG: 2616) has announced the achievement of the primary endpoint in the regulatory GEMSTONE-304 study for its sugemalimab in first-line unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC). This makes sugemalimab the first PD-1 inhibitor to generate positive data in this indication globally. Study…
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3D Medicines Gains FDA Approval for Phase II Study of Envafolimab in dMMR Tumors
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China-based oncology specialist 3D Medicines (HKG: 1244) has announced receiving approval from the US FDA to conduct a single-arm, multi-center Phase II study assessing the safety and efficacy of envafolimab (KN035) in treating deficient mismatch repair (dMMR) advanced solid tumors. The study will involve one subcutaneous injection every three weeks.…
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Changzhou Qianhong Completes Phase I Study of QHRD107 for Acute Myeloid Leukemia
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China-based Changzhou Qianhong Bio-pharma Co., Ltd (SHE: 002550) has announced the completion of enrollment and clinical observation in a Phase I clinical study for its Category 1 drug QHRD107, targeting acute myeloid leukemia (AML). Preliminary findings indicate that the QHRD107 capsule is safe for AML patients, with controllable overall risk…
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Guangdong Zhongsheng Completes Enrollment for RAY1216 Phase III Study in COVID-19
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China – based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced the completion of enrollment for its Phase III study of RAY1216, a drug candidate for the treatment of mild SARS – CoV – 2 infection. The randomized, double – blind, placebo – controlled study has enrolled 1,360 subjects…
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Viking Therapeutics Sues Ascletis Pharma Over Alleged Trade Secret Theft
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US – based Viking Therapeutics (NASDAQ: VKTX) is set to take China’s Ascletis Pharma Inc. (HKG: 1672) to court in the United States over alleged theft of trade secrets and breach of contract. Viking has filed separate complaints with the US District Court of Southern California and the US International…
