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Oricell Therapeutics Closes $45M Series B1 Round for Cellular Immunotherapy
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China-based tumor cellular immunotherapeutics developer Oricell Therapeutics Co., Ltd has announced the closing of a USD 45 million Series B1 investment round. The round was led by premier global industry investors RTW Investments, LP and Qatar Investment Authority, with participation from existing investors, including Qiming Venture Partners and C&D Emerging…
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CStone’s PD-L1 Inhibitor Sugemalimab Accepted for Review in Gastric Cancer
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that the National Medical Products Administration (NMPA) has accepted for review another market filing for its programmed death-ligand 1 (PD-L1) inhibitor sugemalimab. The filing is for the drug’s use in combination with chemotherapy as a first-line treatment of locally advanced or metastatic gastric/gastroesophageal…
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Enhertu Approved in China for HER2-Positive Breast Cancer
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Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody-drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), has been approved by the National Medical Products Administration (NMPA) for the treatment of unresectable or metastatic HER2-positive adult breast cancer patients who have previously received one or more anti-HER2 drugs.…
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Accutar Biotech Begins Phase I Trial for AC0176 in China
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New Jersey-based Accutar Biotechnology Inc., which is heavily backed by Chinese funds, has announced the first patient dosing in a Phase I trial for AC0176, an orally bioavailable chimeric degrader molecule targeting the androgen receptor protein. This marks a significant milestone in the development of innovative treatments for prostate cancer.…
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BeiGene’s Tislelizumab Approved for Gastric Tumors in China
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BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has revealed that its programmed death-1 (PD-1) inhibitor tislelizumab has been approved in China as a first-line therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (G/GEJ) tumors where PD-L1 is overexpressed. Specifically, tislelizumab is approved for use in combination with fluorouracil plus…
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SciClone Partners with Cowell Health to Enhance Cancer Treatment Accessibility
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SciClone Pharmaceuticals Inc. (Nasdaq: SCLN), which became a China-based company after going private in 2017, has struck a partnership with Cowell Health, Hillhouse Capital’s healthcare-focused wholly-owned subsidiary. The collaboration aims to enhance the accessibility and affordability of high-quality drugs and services, explore a new full-course management model for cancer patients,…
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Baheal Pharmaceutical Partners with Novartis for Votrient Commercialization
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China-based health services and distribution giant Baheal Pharmaceutical Group has struck a partnership with Swiss pharmaceutical giant Novartis (NYSE: NVS) to deepen commercialization operations surrounding Novartis’s Votrient (pazopanib). Votrient is a first-line targeted treatment for advanced kidney cancer, offering significant benefits to patients in need. Votrient: Next-Generation TKIVotrient, a next-generation…
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Grand Pharma’s First-in-Class RDC ITM-11 Accepted for IND Review
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China-based Grand Pharmaceutical Group Ltd (HKG: 0512) has announced that an Investigational New Drug (IND) filing for its first-in-class radionuclide drug conjugate (RDC) ITM-11 has been accepted for review. The intended indication for ITM-11 is gastroenteropancreatic neuroendocrine tumors (GEP-NETs), marking a significant step forward in the development of novel treatments…
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Jacobio Pharma Partners with WestChina-Frontier for Preclinical Safety Studies
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China-based Jacobio Pharma (HKG: 1167) has announced a partnership agreement with compatriot firm WestChina-Frontier PharmaTech, a non-clinical research evaluation organization. The collaboration aims to accelerate pre-clinical safety assessment studies for multiple first-in-class drug candidates. Specifically, the two companies will jointly conduct comprehensive toxicological research on multiple preclinical projects, including the…
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Mabwell’s IL-11 Monoclonal Antibody 9MW3811 Approved for Australian Clinical Trial
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced receiving clinical trial approval from the Therapeutic Goods Administration (TGA) of Australia for its 9MW3811, an in-house developed IL-11 monoclonal antibody (mAb) for the treatment of various advanced malignant tumors and fibrotic diseases. This approval marks a significant step forward…
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CStone’s Sugemalimab Accepted for EU Marketing Authorization by EMA
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that the European Medicine Agency (EMA) has accepted a marketing authorization application (MAA) submitted by its US-based partner EQRx for sugemalimab, a programmed death-1 (PD-1) inhibitor. The application is for the use of sugemalimab in combination with chemotherapy as a first-line treatment for…
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Danatlas Raises Pre-Series A Funding for Synthetic Lethality Drug Development
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Beijing-headquartered Danatlas, a first-in-class drug developer specializing in the synthetic lethality field, has reportedly raised “tens of millions” of renminbi in a Pre-Series A financing round. The round was led by Sequoia Capital China and Sherpa Healthcare Partners, with proceeds intended to accelerate the company’s drug research and development (R&D),…
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InnoCare and Keymed Announce First Dosing of ICP-B05 Clinical Study
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China-based firms InnoCare Pharma (HKG: 9969, SHA: 688428) and Keymed Biosciences (HKG: 2162) have jointly announced the first subject dosing of a clinical study for ICP-B05 (CM369), an anti-CC chemokine receptor 8 (CCR8) monoclonal antibody (mAb) developed by their joint venture, Tiannuojiancheng Pharma. This marks a significant milestone in the…
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Roche Returns Global Rights to Blueprint’s RET Inhibitor Gavreto
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US-based biotech Blueprint Medicines has announced that Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY) has returned ex-Greater China global rights to its RET inhibitor Gavreto (pralsetinib), citing strategic reasons. This decision marks a significant shift in the commercial strategy for the drug, which was previously licensed to Roche for global…
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Zai Lab to Present Zejula OS Study Results at ESMO Congress
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China-based Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) is set to present two oral presentations highlighting the ad hoc interim overall survival (OS) study results for the poly (ADP-ribose) polymerase inhibitor (PARPi) Zejula (niraparib). The presentations will focus on the NORA Phase III study and a post hoc analysis from…
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Lepu and Keymed License CLDN18.2 ADC CMG901 to AstraZeneca
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China-based firms Lepu Biopharma Co., Ltd (HKG: 2157) and Keymed Biosciences Inc. (HKG: 2162) have jointly announced a licensing agreement with UK major AstraZeneca (AZ, NASDAQ: AZN) for CMG901, a potential first-in-class antibody-drug conjugate (ADC) targeting Claudin 18.2. AstraZeneca is taking on global development, manufacturing, and commercialization rights to the…
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Abbisko’s ABSK121 Greenlit for Phase I Clinical Study by NMPA
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to carry out a Phase I clinical study for its ABSK121, a fibroblast growth factor receptor (FGFR) drug resistance and mutation inhibitor, in advanced solid tumors. This marks a significant…
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Junshi Biosciences’ PD-1 Inhibitor Tuoyi Shows Promise in Phase III TNBC Study
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Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced significant progress in the Phase III TORCHLIGHT study for its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab). The study, which combines Tuoyi with paclitaxel and albumin, has completed its pre-set interim analysis for initially-diagnosed stage IV or recurrent metastatic triple-negative breast…
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Junshi Biosciences Seeks UK MHRA Approval for PD-1 Inhibitor Tuoyi
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Junshi Biosciences (HKG: 1877, SHA: 688180), a leading China-based biotech firm, has announced the submission of a market approval filing for its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab), to the Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK. The company is seeking approval for the checkpoint inhibitor in…
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Wuhan Binhui’s Oncolytic Virus Therapy Awarded Breakthrough Designation by CDE
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The Center for Drug Evaluation (CDE) website indicates that China-based Wuhan Binhui Biotechnology Co., Ltd’s GM-CSF oncolytic herpes simplex virus type II (OH2) for injection (Vero cells) has been awarded breakthrough therapy designation (BTD) status. This designation is for the treatment of patients with unresectable or metastatic melanoma who have…
