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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…
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Gracell Biotechnologies Gains IND Approval for GC012F in China
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Gracell Biotechnologies has reported receiving Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) for its chimeric antigen receptor (CAR) T cell candidate GC012F. The dual BCMA/CD19-targeted therapy is set to be assessed in treating relapsed/refractory multiple myeloma (r/r MM), marking a significant step in the development…
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RemeGen Gains NMPA Approval for RC48 and Pyrotinib Clinical Study
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China-based RemeGen Ltd (HKG: 9995) has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to initiate an open, single-center Phase Ib/II clinical study. The study will assess the safety, efficacy, and pharmacokinetics of its antibody-drug conjugate (ADC) candidate RC48 (disitamab vedotin) combined with Hengrui pharmamceuticals’ pyrotinib, a…
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Hengrui Pharmaceuticals Licenses SHR2554 to Treeline Biosciences
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China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced a licensing agreement with US-based Treeline Biosciences, Inc. The deal grants Treeline exclusive development, manufacturing, and commercialization rights to the pipeline candidate SHR2554 in markets outside of the Greater China area. This strategic partnership aims to expand the global reach of SHR2554,…
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CSPC Pharmaceutical Licenses ADC SYS6002 to Corbus Pharmaceuticals
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced a licensing agreement with Massachusetts-based Corbus Pharmaceuticals Inc. The deal pertains to CSPC’s anti-nectin-4 antibody drug conjugate (ADC) SYS6002. Under the terms of the agreement, Corbus obtains development and commercialization rights to SYS6002 in the United States, EU, United Kingdom, Canada,…
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Luye Pharma Initiates Phase I Study for BA1106, a CD25 Monoclonal Antibody
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China-based Luye Pharma Group (HKG: 2186) has announced the first subject dosing in a Phase I clinical study for its BA1106, an in-house developed CD25 monoclonal antibody (mAb). The study, filed by subsidiary Shandong BoAn Biotechnology Co., Ltd, is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of…
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Zelgen’s ZGGS15 Accepted for NMPA Review as First Global BsAb Filing
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that a clinical trial filing for its ZGGS15, a bispecific antibody (BsAb) targeting LAG-3 and TIGIT in advanced solid tumors, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant milestone as ZGGS15 is touted…
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Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for Breakthrough Designation
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China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced that its SHR-A1811, an HER2 targeted antibody-drug conjugate (ADC), is on course to obtain breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of unresectable or metastatic breast cancer with low…
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EOC Pharma’s CDK7 Inhibitor EOC237 Accepted for CDE Review
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EOC Pharma, a biotech operating out of the US and China, has announced that a clinical trial filing for its CDK7 inhibitor EOC237 has been accepted for review by the Center for Drug Evaluation (CDE) in China. This marks a significant milestone in the development of EOC237, which is expected…
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Nona Biosciences Partners with Mythic Therapeutics for Next-Gen ADCs
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Nona Biosciences, a wholly owned subsidiary of Harbour BioMed (HKG: 2142), has struck a partnership with US firm Mythic Therapeutics. The collaboration aims to leverage Nona’s HCAb transgenic mice platform technology and antibody discovery services to develop next-generation antibody-drug conjugates (ADCs) targeting multiple tumors. No financial details were disclosed. Partnership…
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Hinova’s HP530S Accepted for NMPA Review as FAK Inhibitor for Solid Tumors
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China-based biopharma Hinova Pharmaceuticals (SHA: 688302) has announced that a clinical trial filing for its HP530S, a highly active and selective focal adhesion kinase (FAK) inhibitor against solid tumors, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of…
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Qilu Pharmaceutical’s QLS12004 Gains Tacit Clinical Trial Approval
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The Center for Drug Evaluation (CDE) website indicates that China-based Qilu Pharmaceutical’s Category 1 chemical drug candidate QLS12004 has obtained tacit clinical trial approval. This marks a significant step forward in the development of new treatments for solid tumors, including advanced breast cancer, which is the leading malignant cancer affecting…
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ImmVira’s MVR-T3011 IT Shows Efficacy in Melanoma Treatment
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Shenzhen-based biopharma ImmVira has revealed that its first intra-tumoral injection oncolytic virus (OV) product, MVR-T3011 IT, has produced positive signs of efficacy as a treatment for melanoma in late-stage patients who have failed previous immunotherapy. In a Phase II clinical study conducted in China and the United States, monotherapy treatment…
