-
Takeda Pharmaceutical’s Teduglutide Filed for Marketing Approval in China
•
The Center for Drug Evaluation (CDE) website in China indicates that Japan-based Takeda Pharmaceutical Co., Ltd’s best-in-class injectable therapy teduglutide has been filed for marketing approval. This marks a significant step for the drug in the Chinese market. Drug BackgroundTeduglutide, the first and only natural glucagon-like peptide-2 (GLP-2) drug approved…
-
Guangzhou Baiyunshan Halts Spinning-off of Guangzhou Pharmaceutical Amid HK Capital Shifts
•
China-based Guangzhou Baiyunshan Pharmaceutical Co., Ltd (SHA: 600332) has announced the suspension of the spinning-off of its subsidiary Guangzhou Pharmaceutical Co., Ltd. This decision comes after considering the reply expiration date from the China Securities Regulatory Commission (CSRC) and changes in the Hong Kong capital market. Regulatory TimelineGuangzhou Pharma first…
-
Frontier Biotech’s Albuvirtide Shows Promising HIV Treatment Results in Phase III Trial
•
China-based Frontier Biotechnologies Inc. (SHA: 688221) has released Phase III trial data for albuvirtide, China’s first homegrown innovative HIV therapy. The non-inferiority “TALENT” study assessed the performance of the long-acting HIV fusion inhibitor albuvirtide in combination with Kaletra (ritonavir-boosted lopinavir) in 418 Chinese patients with HIV-1 over 48 weeks. The…
-
Organon’s China Head Shi Wang Departs to Lead Sanofi Greater China
•
Women’s health specialist Organon (NYSE: OGN) announced the departure of its former China unit head Shi Wang on July 31, with his successor undisclosed. Meanwhile, French major Sanofi revealed that Shi Wang will take the helm of Sanofi Greater China as president and general medicine head as of August 1,…
-
Antengene Receives Australian TGA Approval for ATG-018 Clinical Trial
•
China-based biopharma Antengene Corporation (HKG: 6996) has announced receiving approval from the Therapeutic Goods Administration (TGA) of Australia to initiate a Phase I clinical trial for its candidate ATG-018. The trial, named ATRIUM, will evaluate the drug in patients with advanced solid tumors and hematological malignancies. Drug MechanismATG-018 is an…
-
Helixon Secures RMB 500 Million in Series A Round to Advance AI-Driven Drug Development
•
Beijing-based Helixon, an artificial intelligence (AI)-empowered pharmaceutical company, has reportedly secured RMB 500 million (USD 74.5 million) in a Series A financing round. The funding was led by 5Y Capital, with participation from Gaorong Capital, Neumann Capital, Xiang He Capital, GL Ventures, and Qingzhi Capital. The proceeds will be utilized…
-
Jumbo Drug Bank’s JDB153 Enters Phase I Trial for Advanced Solid Tumors
•
Data from Fineline Cube indicates that JDB153, a potential first-in-class (FIC) small-molecule inhibitor targeting Mnk and VEGFR developed by China-based biotech Jumbo Drug Bank, entered a Phase I clinical study on June 13, 2022. The trial, initiated one week after receiving approval from the National Medical Products Administration (NMPA), is…
-
RemeGen’s Telitacicept Begins Global Phase III Trial for Severe SLE
•
China-based pharmaceutical firm RemeGen (HKG: 9995) has announced the first patient dosing in a global multi-center Phase III clinical study for its fusion protein drug telitacicept, targeting moderate to severe active systemic lupus erythematosus (SLE). The study will be conducted across more than 100 centers in North America, Central/South America,…
-
Suzhou Teligene Ltd Plans IPO on Shanghai STAR Market for Cancer Drug Development
•
China-based Suzhou Teligene Ltd has announced plans for an initial public offering (IPO) of 63.52 million shares on Shanghai’s Sci-Tech Innovation Board (STAR), sponsored by CICC. The proceeds will be allocated towards new drug research and development (R&D) and supplementary working capital. Company Focus and PipelineTeligene, a biopharmaceutical company specializing…
-
BrightGene Bio-Medical Technology Gains NMPA Approval for Oseltamivir Dry Suspension
•
China-based BrightGene Bio-Medical Technology Co., Ltd (SHA: 688166) has announced receiving market approval from the National Medical Products Administration (NMPA) for its oseltamivir dry suspension. The drug is approved for treating influenza A and B in patients aged two weeks and older, and for the prophylaxis of influenza A and…
-
Rakuten Medical Taiwan Administers First Dose of ASP-1929 in Phase II Trial
•
Rakuten Medical Taiwan Inc. announced the administration of its photo-immunotherapy ASP-1929 to the first patient in a Phase II trial at sites in Taiwan. The trial is evaluating the drug in combination with a PD-1 therapy for head and neck squamous cell carcinoma, with the primary endpoint of objective response…
-
BeiGene’s Tislelizumab Accepted for Review in Gastric Cancer Treatment
•
BeiGene (NASDAQ: BGNE) announced that a supplementary Biologic License Application (sBLA) for its programmed death-1 (PD-1) inhibitor tislelizumab has been accepted for review by the Center for Drug Evaluation (CDE). The application seeks approval for tislelizumab in combination with chemotherapy as a first-line treatment for advanced or metastatic gastric or…
-
Zelgen’s Jakitinib Phase III Study Meets Primary Endpoint for Myelofibrosis
•
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that its Phase III clinical study (ZGJAK016) for jakitinib, an in-house Janus kinase (JAK) inhibitor, has achieved primary endpoints. The trial focused on medium- to high-risk myelofibrosis, with the company planning to file for a pre-IND meeting with the Center for Drug…
-
Nanjing CRO Caremo Secures RMB 150 Million in Series A Round
•
Nanjing-based Contract Research Organization (CRO) Caremo has reportedly secured RMB 150 million (USD 22.3 million) in a Series A financing round. The funding was led by Shapuaisi Pharma, with participation from Jolmo Investment, Bondshine Capital, and Huzhou Chunsheng Enterprise Management Partnership Limited. The proceeds will be utilized for constructing a…
-
Lee’s Pharmaceutical Wins NMPA Approval for ALS Drug Teglutik
•
China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has announced receiving market approval from the National Medical Products Administration (NMPA) for its drug Teglutik (riluzole), intended to prolong the life of patients with amyotrophic lateral sclerosis (ALS) or delay the need for mechanical ventilation. Drug Background and MechanismTeglutik, a neuroprotective agent…
-
Winsan Medical Acquires 52% Stake in Goodfeel Dental Clinic for RMB 156 Million
•
China-based Winsan (Chengdu) Medical Science and Technology Co., Ltd (SHA: 600767) is set to acquire a 52% stake in compatriot firm Goodfeel Dental Clinic for a consideration of RMB 156 million (USD 23.2 million). Financial Details and Profit AssuranceThe acquisition values Goodfeel Dental Clinic at approximately RMB 300 million (USD…
-
InnoCare Pharma’s ICP-189 First Dosed in China SHP2 Inhibitor Trial
•
Beijing InnoCare Pharma (HKG: 9969) has announced the first patient dosing in a clinical study of its protein tyrosine phosphatase (SHP2) allosteric inhibitor ICP-189 in China. The drug is being developed to treat liver cancer, head and neck cancer, digestive tract tumors, and other solid tumors. Mechanism and Preclinical ResultsICP-189…
-
China NT Pharma Group Inks Licensing Deal for Orticumab in Asia
•
China-based China NT Pharma Group Company Ltd (HKG: 1011) has announced a licensing agreement with US firm Abcentra LLC. Under the terms, its subsidiary Green-Life Technology (Hong Kong) Co., Ltd will gain exclusive, permanent commercial rights to NT Pharma’s monoclonal antibody orticumab for Greater China, Singapore, Malaysia, and Thailand. Orticumab,…
-
Mega Genomics Limited Makes Hong Kong IPO Debut at HKD 18 Per Share
•
China-based gene testing platform company Mega Genomics Limited has successfully completed an initial public offering (IPO) of 12 million shares on the Hong Kong Stock Exchange at HKD 18 (USD 2.98) per share. The offering, sponsored by China Securities, marks a significant milestone for the company as it seeks to…
-
Venus Medtech’s VenusP-Valve Used Compassionately in US for Pulmonary Regurgitation
•
Venus Medtech (Hangzhou) Inc. (HKG: 2500) announced the first compassionate use of its VenusP-Valve, a transcatheter pulmonary valve replacement (TPVR) system, at the University of Virginia Advanced Cardiac Valve Center in the United States. This procedure marks a significant milestone for the VenusP-Valve, which is designed to treat patients with…
