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Jumpcan Partners with Newsoara for PDE4 and Protease Inhibitors in China
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China-based Jumpcan Pharmaceutical (SHA: 600566) has announced a partnership with compatriot firm Newsoara BioPharma Co., Ltd to develop and commercialize two target products in mainland China. The collaboration involves a PDE4 inhibitor (target product one) and a protease inhibitor (target product two). Jumpcan will pay RMB 180 million (USD 24.8…
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Novo Nordisk to Invest RMB 400M in Shanghai at CIIE
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Novo Nordisk (NYSE: NVO) has announced at the 5th China International Import Expo (CIIE) an investment of RMB 400 million (USD 55.2 million) to establish an investment unit in Shanghai. The new unit is designed to maintain ownership of its manufacturing, trade, research and development (R&D), and other business operations…
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Jiangsu Yahong Initiates Phase III Study for Hexvix in Bladder Cancer Detection
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China-based urogenital cancer specialist Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176) has announced the enrollment of the first subject in a prospective, subject-controlled, multi-center Phase III clinical study. The study aims to assess the additional detection rate and safety of Hexvix, a bladder cancer diagnosis and postoperative detection product,…
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Betta Pharmaceuticals’ BPI-452080 Accepted for Review by NMPA
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China’s Betta Pharmaceuticals (SHE: 300558) has announced that a clinical trial filing for its Category 1 drug candidate BPI-452080 has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development of the drug, which is designed to treat advanced solid…
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Qilu Regor’s RGT-264 Phosphate Tablets Approved for Phase I Study
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China-based biotech Qilu Regor Therapeutics Inc has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase I study. The study will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of its RGT-264 phosphate tablets in patients with advanced solid tumors. RGT-264 ProfileRGT-264 is a…
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Hainan Free Trade Port to Simplify Drug Import Procedures
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The “Provisions on Facilitation of Drug Import in Hainan Free Trade Port,” released in September this year, will take effect as of December 1, 2022. These new regulations aim to streamline the import process for pharmaceuticals, enhancing efficiency and reducing administrative burdens. Regulatory ChangesThe Provisions specify that enterprises importing drugs…
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Hainan Free Trade Port to Simplify Drug Import Procedures
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The “Provisions on Facilitation of Drug Import in Hainan Free Trade Port,” released in September this year, will take effect as of December 1, 2022. These new regulations aim to streamline the import process for pharmaceuticals, enhancing efficiency and reducing administrative burdens. Regulatory ChangesThe Provisions specify that enterprises importing drugs…
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Reforgene Medicine RM-001 Thalassemia Gene Editing
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China-based Guangzhou Reforgene Medicine Co., Ltd’s in-house developed β-thalassemia gene editing drug RM-001 (HBG gene modified autologous CD34+ hematopoietic stem cell injection) has obtained tacit clinical trial approval from the National Medical Products Administration (NMPA). This marks a significant milestone for the first thalassemia gene editing novel drug program in…
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Walvax Biotech Launches Phase IIIb Trial for mRNA COVID-19 Vaccine
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced the initiation of a Phase IIIb clinical study with ethics approval. The study is designed to assess the immunogenicity and safety of its “novel coronavirus variant mRNA vaccine” (S protein chimera) in individuals aged 18 and above who have completed three…
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Guangdong Zhongsheng Initiates Phase III Study for RAY1216 in COVID-19
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced the initiation of a randomized, double-blind, placebo-controlled Phase III study with ethics approval for its RAY1216 in mild and common SARS-CoV-2 infection. The study is expected to enroll 1,070 patients with mild and common COVID-19 infection, using placebo as the…
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Bloomage Biotech CEO Investigated Over Discounted Share Sales
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The chairwoman of Chinese medical aesthetics player Bloomage Biotech Corp., Ltd (SHA: 688363), Ms. Zhao Yan, is facing an investigation from stock exchange authorities following whistleblower accusations that she pressured employees into selling their shares in the company at a discount. The China Securities Regulatory Commission (CSRC) and Shandong Securities…
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NMPA Proposes ‘Drug Online Sales Blacklist’ for Public Feedback
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The National Medical Products Administration (NMPA) has released a draft proposal for a “Drug Online Sales Blacklist,” soliciting public feedback. The draft clearly prohibits the online sale of certain high-risk and controlled substances to ensure patient safety and regulatory compliance. Prohibited DrugsThe draft proposal prohibits the online sale of the…
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Ascentage Pharma Announces Clinical Advances for Olverembatinib at ASH
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Suzhou-based Ascentage Pharma (HKG: 6855) announced the latest clinical development of its olverembatinib (HQP1351), a third-generation BCR-ABL-targeted tyrosine kinase inhibitor (TKI), Bcl-2 inhibitor lisaftoclax (APG-2575), and MDM2-p53 inhibitor alrizomadlin (APG115) at the 64th American Society of Hematology (ASH) annual meeting this year. Olverembatinib in CML and Ph+ALLOlverembatinib can overcome drug…
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Abbisko Enrolls First Patient in Phase II Study for ABSK091 in Urothelial Carcinoma
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China-based Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the enrollment of the first patient in a Phase II clinical study for its investigational pan-FGFR inhibitor ABSK091, in combination with BeiGene Ltd’s anti-PD-1 antibody tislelizumab, for the treatment of urothelial carcinoma (UC). This marks the first clinical combination trial of…
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Blue Shield Pharma’s LD013 CAR-T Therapy Approved for Clinical Trials
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China-based Blue Shield Biotech’s in-house developed LD013, an autologous chimeric antigen receptor (CAR)-T cell therapy, has obtained clinical trial approval from the National Medical Products Administration (NMPA). The intended indication is recurrent refractory ovarian cancer, a condition that poses significant challenges in treatment and management. Mesothelin as a TargetMesothelin (MSLN)…
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Biomed Union Raises RMB 200M in Series B Round for Diagnostic Products
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Biomed Union (formerly known as Shanghai Biomed-union Biotechnology Co., Ltd), a tumor molecular diagnostic technology and cellular technology specialist based in Zhejiang, has reportedly raised close to RMB 200 million (USD 27.5 million) in a Series B financing round. The round was led by Kequan Fund in the Anji County…
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Yaguo Technology Secures Series A+ Funding for Airway Management Devices
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Yaguo Technology Co., Ltd, an airway management and respiratory therapy device maker based in Beijing, has reportedly raised “tens of millions” of renminbi in a Series A+ financing round. The round was led by Weifang Zhongke Haichuang Equity Investment Partnership, with contributions from Beijing Jinke Huiyu Venture Capital Partnership. The…
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Novatim Immune Therapeutics Raises RMB 500M in First Financing Round
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China-based tumor immunotherapy developer Novatim Immune Therapeutics (Zhejiang) Co., Ltd. has reportedly raised close to RMB 500 million (USD 68.9 million) in its first financing round. The round was led by Kequan Fund in the Anji County Economic Development Zone. The proceeds will be used for core product clinical studies,…
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Pulnovo Medical Raises ‘Tens of Millions’ in New Financing Round
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Pulnovo Medical, a pulmonary hypertension (PH) medical device maker based in Wuxi, has reportedly raised “tens of millions” of US dollars in another financing round. The round was led by Yuanbio Venture Capital, with participation from OrbiMed, Cenova Ventures, Lilly Asia Ventures, Gaorong Capital, Huihe Capital, and GC&H Investments. The…
