-
Syneos Health Partners with Fosun Pharma to Commercialize Serplulimab in US
•
US-based Syneos Health (Nasdaq: SYNH) has revealed a strategic partnership with Fosun Pharma USA Inc., a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196, SHA: 600196), focused on the anti-programmed death-1 (PD-1) inhibitor serplulimab. Syneos will provide full commercial support in the United States for serplulimab’s development as…
-
Roche’s Polivy Approved by China’s NMPA for Lymphoma Treatment
•
Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that the National Medical Products Administration (NMPA) has approved its antibody-drug conjugate (ADC) Polivy (polatuzumab vedotin for injection). Polivy is the world’s first ADC targeting CD79b and is designed for use as a first-line treatment for diffuse large B-cell lymphoma…
-
Takeda’s Mobocertinib Approved in China for EGFR Exon20ins NSCLC
•
Japan-based Takeda Pharmaceutical Co., Ltd’s (TYO: 4502) China unit has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its lung cancer therapy mobocertinib. The drug is indicated for use in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed during…
-
Kelun-Biotech’s SKB264 Approved for Phase II Study in EGFR-Mutant NSCLC
•
China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its drug candidate SKB264. The antibody-drug conjugate (ADC) targets trophoblast cell-surface antigen 2 (TROP2) and will be evaluated in combination with AstraZeneca’s (AZ, NASDAQ: AZN)…
-
BeiGene Outlines Global R&D Strategy at J.P. Morgan Healthcare Summit
•
China-based biotech BeiGene (Nasdaq: BGNE, HKG: 6160) provided an update on its company strategy and R&D plans at this week’s J.P. Morgan Healthcare Summit in San Francisco. BeiGene CEO John Oyler presented the firm’s globally disruptive R&D model, which includes in-house discovery capabilities and new treatment modalities set to drive…
-
Evopoint Biosciences Licenses SOS1 Inhibitor to METiS Therapeutics
•
China-based Evopoint Biosciences has announced a global licensing agreement with US firm METiS Therapeutics Inc., granting METiS exclusive global development and commercialization rights to Evopoint’s SOS1 inhibitor. Under the agreement, METiS Therapeutics will pay Evopoint “hundreds of millions” of US dollars in total upfront payment and milestone payments, along with…
-
Konruns Initiates Phase II Study for KC1036 in Advanced Thymic Tumors
•
Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has announced the initiation of a single-arm, open, multi-center Phase II clinical study to assess the efficacy and safety of its Category 1 chemical drug KC1036 in patients with advanced thymoma and thymic carcinoma. The study focuses on patients whose disease has progressed…
-
Dizal’s Sunvozertinib NDA Accepted for Review by China’s NMPA
•
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that its New Drug Application (NDA) filing for sunvozertinib (DZD9008), a next-generation epidermal growth factor receptor (EGFR) inhibitor, has been accepted for review by the National Medical Products Administration (NMPA). The drug is indicated for use in locally advanced or metastatic…
-
Treadwell Therapeutics’ CFI-402257 Granted Fast-Track Status by FDA
•
China-based clinical-stage biotech Treadwell Therapeutics has announced receiving fast-track status from the US Food and Drug Administration (FDA) for its CFI-402257, a best-in-class inhibitor of threonine tyrosine kinase (TTK, also known as Mps1). The designation was granted for the drug’s potential as a treatment for adult patients with ER+/HER2- advanced…
-
Jiangsu Kanion’s KYS202002A Greenlit for Clinical Study in Multiple Myeloma
•
China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its pipeline candidate KYS202002A in recurrent/refractory multiple myeloma (R/R MM). This marks a significant step forward in the development of this innovative therapy targeting a…
-
Yiling Pharmaceutical’s BIO-008 Accepted for Review by China’s NMPA
•
China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that its clinical trial filing for BIO-008, an in-house developed Category 1 biologic being developed to treat advanced solid tumors, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development…
-
Luye Pharma Launches Named Patient Program for Lurbinectedin in Hong Kong
•
China-based Luye Pharma Group (HKG: 2186) has announced the launch of a Named Patient Program (NPP) in Hong Kong, enabling access to lurbinectedin (LY01017), an RNA polymerase II inhibitor used to treat patients with relapsed small-cell lung cancer (SCLC). The program will provide immediate access to the drug for SCLC…
-
Roche’s Glofitamab and Dizal’s Sunvozertinib Enter Priority Review
•
The Center for Drug Evaluation (CDE) website indicates that Swiss giant Roche’s (SWX: ROG) glofitamab (RO7082859) and China-based Dizal Pharmaceutical Co., Ltd’s sunvozertinib (DZD9008) are set to enter the priority review process. This marks a significant step forward for both drugs, which are poised to address significant unmet needs in…
-
Suzhou Thery’s Generic Nilotinib Approved by China’s NMPA
•
China-based Suzhou Thery Pharmaceutical Inc. has announced that the National Medical Products Administration (NMPA) has approved its generic version of Novartis’s (NYSE: NVS) cancer therapy Tasigna (nilotinib). Thery filed a “4.1 certification” under China’s patent linkage system, directly challenging the validity of Tasigna’s patent. Thery is the first company to…
-
Zhifei Biological Products’ BCG Vaccine Filing Accepted by China’s NMPA
•
China-based Chongqing Zhifei Biological Products Co., Ltd (SHE: 300122) has announced that its clinical trial filing for an in-house developed therapeutic BCG vaccine has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of a new treatment option for bladder…
-
Yantai Dongcheng Pharma Gets FDA Go-Ahead for 177Lu-LNC1004 Clinical Trial
•
China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its 177Lu-LNC1004 in advanced fibroblast activation protein (FAP)-positive solid tumors. This marks a significant step in the development of this innovative…
-
Jacobio Pharma Doses First Patient in US Phase I/IIa Study for JAB-2485
•
China-based Jacobio Pharma (HKG: 1167) has announced that the first patient has been dosed in a Phase I/IIa clinical study being carried out in the United States for its Aurora A inhibitor JAB-2485. The initial indication for the study is general advanced solid tumors, marking a significant step in the…
-
Dizal’s Sunvozertinib and Golidocitinib Combo Gets NMPA Approval for Phase II Study
•
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the safety, tolerability, and efficacy of its next-generation epidermal growth factor receptor (EGFR) inhibitor sunvozertinib (DZD9008) in combination with the JAK1 inhibitor golidocitinib (DZD4205).…
-
Zai Lab and Novocure’s TTFields Device Shows Survival Benefit in Lung Cancer Study
•
Shares in Chinese firm Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) and its partner Novocure (NASDAQ: NVCR) surged yesterday after the companies revealed positive results from the Phase III LUNAR study. The study assessed the efficacy of the TTFields electrical field medical device in combination with immunotherapy for patients with…
-
Immune-Onc Therapeutics Completes $131 Million Series B Financing
•
US-headquartered Immune-Onc Therapeutics, Inc. has announced the successful completion of a Series B financing round totaling USD 131 million, including a USD 25 million extension. The extension was led by existing investor Triwise Capital, with participation from new investors such as Proxima Ventures. Additionally, the company received continued strategic capital…
