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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…
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CSPC’s NBL-020 Gets NMPA Approval for Clinical Study in Advanced Solid Tumors
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to initiate a clinical study for the antibody drug NBL-020. This marks a significant step forward in the development of new treatments for advanced solid tumors. NBL-020: Anti-Tumor Necrosis Factor Type…
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Topgen Biopharm Partners with Fudan University for Breast Cancer Gene Detection
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Zhejiang-based tumor precision medicine specialist Topgen Biopharm Co., Ltd has entered into a strategic partnership with Fudan University Shanghai Cancer Center. The RMB 31 million (USD 4.5 million) deal will see the two Chinese entities collaborate on the translation of “breast cancer multi-gene detection” technology, marking a significant step forward…
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Shanghai-Based REMD Raises Series A+ Funding for Electroporation Device Expansion
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Shanghai-based REMD, a leading manufacturer of irreversible electroporation devices, has reportedly raised over RMB 100 million (USD 14.54 million) in a Series A+ financing round. The round was led by Silicon Paradise Asset Management, with additional investments from DT Capital Partners and Qianzhan Investment. The proceeds will be used to…
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Kanghong’s KH617 Receives Orphan Drug Designation for Glioblastoma
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China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced receiving an Orphan Drug Designation (ODD) from the US FDA for its Category 1 drug candidate KH617 in glioblastoma. This designation is a significant milestone in the development of KH617, which is aimed at treating advanced solid tumors and…
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Junshi Biosciences and Coherus Report Positive JUPITER-02 Trial Results for NPC Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) and its US partner Coherus BioSciences Inc., (NASDAQ: CHRS) have announced positive findings from the final analysis of overall survival (OS) in the pivotal Phase III JUPITER-02 (NCT03581786) clinical study. The study assessed the programmed death-1 inhibitor Tuoyi (toripalimab) as a…
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Zelgen’s ZG2001 and ZG0895 Clinical Trials Approved by NMPA
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that separate clinical trial filings for its Category 1 product candidates ZG2001 and ZG0895 have both been accepted for review by the National Medical Products Administration (NMPA) in China. This marks a significant milestone in the development of these innovative drug…
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Hygea Medtech Secures Series D Funding for Oncology Device Expansion
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Hygea Medical Technology Co., Ltd, a leading minimally invasive device maker for oncology indications based in Beijing, has reportedly raised “hundreds of millions” of renminbi in a Series D financing round. This significant funding round was led by In Capital, with contributions from Banyan Pacific Capital, Huajin Capital, Qiandao Investment…
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Harbour BioMed Licenses HBM7008 to Cullinan Oncology for US Development
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Harbour BioMed (HBM), which operates out of the Netherlands, the United States, and Suzhou, China, has announced a licensing agreement with US firm Cullinan Oncology, Inc. The deal grants Cullinan exclusive rights to develop and commercialize HBM7008 in the United States (including the District of Columbia and Puerto Rico). This…
