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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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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…
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Akeso Biopharma Completes Enrollment for AK112 Phase III Study
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China-based Akeso Biopharma (HKG: 9926) has announced the completion of enrollment for its Phase III study of AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF). The study aims to assess the drug in combination with chemotherapy for locally advanced or metastatic non-squamous non-small…
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Eccogene Gains FDA Approval for Phase I Study of ECC5004
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Shanghai-based Eccogene has announced receiving approval from the US FDA to initiate a Phase I clinical study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of ECC5004, a glucagon-like peptide 1 receptor agonist (GLP-1 RA) targeting type 2 diabetes mellitus (T2DM), in healthy participants and subjects with T2DM. GLP-1 Mechanism and…
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BeiGene’s Brukinsa Receives EU Marketing Approval for Marginal Zone Lymphoma
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China-based biotech BeiGene Inc. (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced receiving marketing approval from the European Committee (EC) for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The drug is now approved in the EU for the treatment of relapsed/refractory (R/R) marginal zone lymphoma (MZL) in patients who have…
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Dartsbio Licenses Potential First-in-Class BsAb DS005 to Duality Biologics
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China-based Dartsbio Pharmaceuticals, Ltd has announced a licensing deal with Duality Biologics, a novel modality drug developer operating out of the United States and China. The agreement grants Duality Biologics global rights to Dartsbio’s in-house developed, potential first-in-class bispecific antibody (BsAb) DS005 to develop a new antibody drug conjugate (ADC).…
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Fosun Pharma Terminates Equity Transfer Deal with OncoCare Medical
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced the termination of an equity transfer deal with OncoCare Medical Pte. Ltd. The decision follows the inability to fulfill all preconditions for the transaction within the agreed period. Deal OverviewIn June this year, Fosun Pharma had agreed to…
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Antengene’s CD73 Inhibitor ATG-037 Greenlit for Phase I Study by NMPA
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China-based Antengene Corporation Limited (HKG: 6996) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase I study assessing its ATG-037, a small molecule inhibitor of CD73, in patients with locally advanced or metastatic solid tumors. This marks a significant step forward in the development…
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Sino Medical Sciences’ Non-Compliant Balloon Catheter Approved by NMPA
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China-based Sino Medical Sciences Technology Inc. (SHA: 688108) has announced receiving market approval from the National Medical Products Administration (NMPA) for its non-compliant balloon dilation catheter. This approval marks a significant step forward in the company’s efforts to enhance cardiovascular treatment options. Product ProfileThe non-compliant balloon dilation catheter is now…
