-
CSPC Pharmaceutical Group Receives NMPA Approval for SYH9016 Clinical Study in Solid Tumors
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its GnRH receptor agonist, SYH9016, in the treatment of solid tumors. SYH9016: A Modified Leuprorelin Product for Solid TumorsSYH9016 is a novel modified…
-
MicuRx Pharmaceuticals’ MRX-5 Receives FDA Orphan Drug Designation for NTM Infections
•
Sino-US firm MicuRx Pharmaceuticals Inc. has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its in-house developed antibiotic, MRX-5, for the treatment of non-tuberculosis Mycobacterium (NTM) infections. MRX-5: A Promising New Antibiotic for NTMMRX-5 is a novel benzodiazole antibiotic specifically designed to…
-
Hengrui Pharmaceuticals and IDEAYA Biosciences Ink Licensing Deal for SHR-4849
•
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced a significant licensing agreement with US-based IDEAYA Biosciences Inc., (NASDAQ: IDYA). Under this agreement, Hengrui will grant IDEAYA development, manufacturing, and commercialization rights to its novel DLL3-targeting Topo-I-payload antibody drug conjugate (ADC), SHR-4849, for markets worldwide outside of Greater China. Financial…
-
CARsgen Therapeutics’ Satricabtagene Autoleucel Shows Positive Results in Phase II Study
•
China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced positive results from its pivotal Phase II CT041-ST-01 study for satricabtagene autoleucel, a chimeric antigen receptor (CAR) T-cell therapy. The study, which is randomized, controlled, and multi-center, aims to evaluate the efficacy and safety of the therapy in patients with CLDN18.2-expressing…
-
argenx’s Vygart Hytrulo Approved in Japan for Chronic Inflammatory Demyelinating Polyneuropathy
•
Holland-based argenx SE (NASDAQ: ARGX) has announced receiving another indication approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). This approval allows the drug to be used for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP), who can…
-
Daiichi Sankyo’s Datroway Approved in Japan for HR+, HER2- Breast Cancer
•
Japan-based pharmaceutical company Daiichi Sankyo (TYO: 4568) has announced that it has received marketing approval in Japan for its datopotamab deruxtecan, to be sold under the commercial name Datroway. Datroway is indicated for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative unresectable or recurrent breast cancer,…
-
MabPharm’s CMAB807 Biosimilar Receives Market Approval in Indonesia and Peru
•
Taizhou-based MabPharm Ltd (HKG: 2181), a specialist in monoclonal antibody (mAb) biosimilars, has announced the receipt of market approval for CMAB807, a biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) Remicade (infliximab), in Indonesia, with a similar approval in Peru in July this year. The approval encompasses all six…
-
Shanghai Ark Biopharmaceutical Partners with Partex to Advance AI-Driven Drug Development
•
China’s Shanghai Ark Biopharmaceutical Co., Ltd. has formed a strategic alliance with Germany-based Partex, an artificial intelligence (AI)-empowered drug developer. This partnership aims to explore the potential of AK0707, an autotaxin inhibitor developed in-house by Ark Bio. Partex will utilize its AI-driven platform to uncover potential indications for the drug.…
-
Zhongheng Group and Fosun Pharmaceutical Form JV to Boost Overseas Business
•
China-based Zhongheng Group (SHA: 600252) has announced plans to establish a joint venture (JV) with fellow Chinese firm Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) in Nanning, the capital city of Guangxi province. Fosun Pharmaceutical is investing RMB51 million (USD6.99 million) for a 51% stake in the…
-
BeiGene’s Tevimbra Receives FDA Approval for HER2-Negative Gastric Cancer Treatment
•
China-based biopharmaceutical company BeiGene Ltd (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that the US Food and Drug Administration (FDA) has granted another indication approval for its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab). This new approval allows the use of tislelizumab in combination with platinum and fluoropyrimidine-based chemotherapy to…
-
Huadong Medicine Partners with SynerK PharmaTech for Hypertension siRNA Drug Development
•
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced a strategic partnership agreement with SynerK PharmaTech (Suzhou) Co., Ltd., an RNA-targeted therapies developer with operations in Boston, US, and Suzhou and Beijing, China. The collaboration aims to develop an angiotensinogen (AGT)-targeted small nucleic acid (siRNA) drug for the treatment of…
-
Bristol-Myers Squibb’s Opdivo Qvantig Receives FDA Approval for Expanded Indications
•
Global biopharmaceutical company Bristol-Myers Squibb (BMS, NYSE: BMY) has announced that the US Food and Drug Administration (FDA) has granted marketing approval for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy). This combination product pairs nivolumab with recombinant human hyaluronidase (rHuPH20) and is set to be used in most previously approved adult solid…
-
HitGen Inc. Initiates Phase II Clinical Trial for HG146 in Adenoid Cystic Carcinoma
•
China-based HitGen Inc. (SHA: 688222) has announced the commencement of the first patient enrollment in a Phase II clinical study for its Category 1.1 anti-tumor drug, HG146. This study focuses on the treatment of recurrent or metastatic adenoid cystic carcinoma, a rare and aggressive form of cancer. HG146: A Promising…
-
Reforgene Medicine Secures Hundreds of Millions in Financing for Gene Therapy Expansion
•
Reforgene Medicine, a prominent gene editing therapy company headquartered in Guangzhou, has reportedly secured hundreds of millions of renminbi in a new financing round. This funding round was led by Guangzhou Industry Investment, with additional contributions from Guangzhou Financial Holdings, Technology Financial Holdings, and returning investor IFSC. The capital raised…
-
Xtalpi Inc. Partners with NCCS and Duke-NUS to Advance AI-Driven Drug Discovery
•
Shenzhen-based QuantumPharm Inc., trading under the name Xtalpi Inc. (HKG: 2228), has announced a strategic partnership with the National Cancer Center Singapore (NCCS) and Duke-NUS Medical School. This collaboration will harness the power of artificial intelligence (AI) to revolutionize the discovery and design of clinical drug candidates. AI-Driven Peptide Research…
-
Danaher Corporation Opens Joint Office in Beijing’s Chaoyang District
•
US-based Danaher Corporation (NYSE: DHR), a leading science and tech services provider, has officially launched its joint office in Northern China. The new facility is strategically located in the Chaoyang District of Beijing and spans an impressive 1,500 square meters. Subsidiaries Under One RoofThe state-of-the-art office brings together several of…
-
WuXi Biologics Partners with Sino Biopharmaceutical for First-in-Class Monoclonal Antibody Development
•
China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has announced a significant research service cooperation agreement with fellow firm Sino Biopharmaceutical Ltd (HKG: 1177). This partnership aims to empower Sino Biopharmaceutical in the development of a first-in-class monoclonal antibody (mAb), with the target currently undisclosed. Comprehensive…
-
GenFleet Therapeutics Submits IPO Application to HKEX, Backed by CITIC Securities
•
On December 27, 2024, GenFleet Therapeutics, a biopharmaceutical company based in Shanghai, submitted its application for listing on the Hong Kong Stock Exchange (HKEX), with CITIC Securities serving as the exclusive sponsor and overall coordinator. Company Background and FocusEstablished in 2017, GenFleet Therapeutics is a market-stage biopharmaceutical company specializing in…
-
Overwhelming Shareholder Support for Hengrui Pharmaceuticals’ H-Share IPO
•
On December 26, Hengrui Pharmaceuticals (SHA: 600276) held its second extraordinary general meeting of 2024, where the primary agenda was to discuss the company’s proposal to issue H shares and list them on the Hong Kong Stock Exchange (HKEX). Landmark Approval for H-Share IssuanceThe outcome of the deliberation was overwhelmingly…
-
Dynamiker Biotechnology Receives Approval for IPO on Beijing Stock Exchange
•
On December 27, 2024, the official website of the Beijing Stock Exchange announced that Dynamiker Biotechnology (Tianjin) Co., Ltd. has received approval for its initial public offering (IPO) from the listing committee, with Citic Securities serving as the sponsor. The company aims to raise RMB 456 million (approximately USD 64…
