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Innovent’s IBI343 Receives Breakthrough Therapy Designation for Pancreatic Cancer
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China-based biopharma Innovent Biologics, Inc. (HKG: 1801) has announced receiving another Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its IBI343. The latest designation was granted for the TOPO1i anti-CLDN18.2 antibody drug conjugate (ADC) as monotherapy for the treatment…
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Hengrui’s SHR-9839 Receives NMPA Clearance for Advanced Tumors
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving clinical clearance from the National Medical Products Administration (NMPA) for its SHR-9839 subcutaneous (SC) injection in advanced solid tumors. This clearance marks a significant step forward in the development of innovative treatments for patients with advanced malignant tumors. SHR-9839:…
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Chipscreen’s Epidaza Patent Faces Invalidation Request Review
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China-based Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321) has announced that a patent invalidation request filed by compatriot firm Chia Tai Tianqing relating to its Epidaza (chidamide) has been accepted for review by the China National Intellectual Property Administration (CNIPA). This development marks a significant legal milestone in the protection…
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Bristol-Myers Squibb Exercises License for ArsenalBio’s AB-4000 Series
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US-based cell therapy company Arsenal Biosciences, Inc. has announced that Bristol-Myers Squibb (BMS, NYSE: BMY) has exercised its exclusive license option for the AB-4000 series. This program originated from a multi-year agreement between the two companies, which was initially established in December 2020, aimed at advancing next-generation T cell therapies…
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MediLink Therapeutics and AstraZeneca Collaborate on YL201 and Imfinzi Combo for Solid Tumors
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Suzhou-based biotech company MediLink Therapeutics (Suzhou) Co., Ltd has announced a clinical cooperation agreement with UK pharmaceutical major AstraZeneca (AZ; NASDAQ: AZN). The collaboration aims to explore the potential of combining MediLink’s YL201 with AstraZeneca’s Imfinzi (durvalumab) in the treatment of multiple solid tumors. Upcoming Phase I/Ib StudyA multi-center, open…
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CSPC Pharmaceutical’s ADC Pipeline Advances with SYS 6041 Approval
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China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has reported significant progress in its antibody drug conjugate (ADC) pipeline. The company’s latest product, SYS 6041, has recently been cleared for study in advanced solid tumors in China. This approval marks a crucial step in the development of CSPC’s ADC portfolio,…
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Henlius Biotech Gains NMPA Clearance for HLX43 ADC Study
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that it has received clearance from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II study for its antibody drug conjugate (ADC) drug HLX43, combined with the anti-programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab, HLX10), in patients with advanced/metastatic solid…
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Hengrui Pharmaceuticals Receives NMPA Approval for SHR-4375 Clinical Trial
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its therapeutic biologic product SHR-4375. This approval is a significant milestone in the development of SHR-4375, which is designed to treat advanced malignant solid tumors.…
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Menarini Group Expands Oncology Pipeline with Insilico Medicine License
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Italy’s Menarini Group, through its subsidiary Stemline Therapeutics Inc., has entered into a licensing deal with China-based AI drug discovery firm Insilico Medicine. The agreement grants Menarini global development and commercialization rights to a preclinical small molecule targeting oncology indications. This strategic move further expands Menarini’s oncology pipeline, leveraging Insilico’s…
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NMPA Approves J&J’s FGFR Kinase Inhibitor Balversa for Urothelial Carcinoma
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China’s National Medical Products Administration (NMPA) has approved Johnson & Johnson’s (J&J; NYSE: JNJ) FGFR kinase inhibitor Balversa (erdafitinib) for the treatment of adult patients with unresectable locally advanced or metastatic urothelial carcinoma (UC). The drug is indicated for patients who carry susceptible FGFR3 gene mutations and have undergone at…
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Fosun Pharmaceutical’s FCN-437c Accepted for NMPA Review for Breast Cancer Treatment
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Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196, SHA: 600196) has announced that another market approval filing for its FCN-437c 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 patients with hormone receptor (HR)…
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Sinogen’s SalMet-Vec Receives FDA Orphan Drug Designation for Pancreatic Cancer
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China’s oncology specialist Guangzhou Sinogen Pharmaceutical Co., Ltd. has announced receiving Orphan Drug Designation (ODD) from the US FDA for its SalMet-Vec in pancreatic cancer. This oncolytic bacteria drug has previously earned ODD statuses from the agency for osteosarcoma, hepatocellular carcinoma, and small cell lung cancer. Drug Profile and MechanismSalMet-Vec…
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Boehringer Ingelheim Licenses ADC Technology from Synaffix to Boost Portfolio
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German giant Boehringer Ingelheim has announced the licensing of antibody drug conjugate (ADC) technology from Synaffix B.V., a subsidiary of Switzerland’s Lonza (SWX: LONN). This strategic deal is expected to significantly enhance Boehringer’s ADC portfolio, driven by its subsidiary, NBE Therapeutics. Agreement DetailsUnder the terms of the agreement, Synaffix will…
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MediLink and Zai Lab Collaborate on LRRC15-Targeted ADC Drug ZL-6201
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Chinese biotechs MediLink Therapeutics (Suzhou) Co., Ltd and Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) have entered into a collaboration and license agreement. MediLink’s TMALIN antibody drug conjugate (ADC) platform will be utilized to develop ZL-6201, a novel LRRC15-targeted ADC drug discovered by Zai Lab, for the treatment of solid…
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Astellas’ Padcev and Keytruda Combo Cleared by NMPA for Urothelial Cancer
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced marketing clearance by China’s National Medical Products Administration (NMPA) for its Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) to treat adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This combination offers a new therapeutic option to patients in China,…
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MSD’s Gardasil Vaccine Gains NMPA Approval for Use in Males Aged 9 to 26
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US major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its recombinant human papillomavirus (HPV) quadrivalent vaccine, Gardasil, for use in males aged 9 to 26. This approval expands the vaccine’s application to include prevention…
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Inceptor Bio and GRIT Biotechnology Partner to Advance CAR-T Therapy IB-T101 for Solid Tumors
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US-based Inceptor Bio has entered into a partnership with Chinese firm GRIT Biotechnology to advance the potential best-in-class chimeric antigen receptor (CAR)-T therapy, IB-T101, for the treatment of solid tumors. This collaboration combines the expertise of two cell therapy specialists to enhance the development and commercialization of innovative cancer treatments.…
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PKU 1st Hospital Partners with Baheal Pharmaceutical on Integrin-Targeted Inhibitor Project
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Peking University First Hospital (PKU 1st Hospital) has partnered with China-based health services and distribution giant Baheal Pharmaceutical Group for its integrin-targeted small molecule inhibitor project. The deal, valued at RMB 70 million (USD 9.5 million), grants Baheal exclusive global rights for patent, clinical development and regulatory filing, manufacturing, and…
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Junshi Biosciences’ Loqtorzi Gains Regular Approval for Melanoma Treatment in China
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that its PD-1 inhibitor, Loqtorzi (toripalimab), has received regular approval in China for the treatment of unresectable or metastatic melanoma that has previously failed systemic therapy. This marks a significant milestone in the drug’s regulatory journey. Background and Approval…
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Simcere Zaiming’s SIM0505 Receives NMPA Approval for Clinical Trials in Advanced Solid Tumors
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China-based Simcere Pharmaceutical Group Limited’s (HKG: 2096) subsidiary, Simcere Zaiming, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC) SIM0505, which targets CDH6 in advanced solid tumors. Last month, the drug also received clearance for clinical trials…
