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Xiling Lab Raises RMB 100 Million for ADC Development and IND Filing
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Xiling Lab, a Chengdu-based drug developer specializing in catalytic synthesis technology, has reportedly raised close to RMB 100 million (USD 13.96 million) in a Pre-Series B financing round. Investors included Chengdu Bio City No. 1 Equity Investment Fund, Chengdu Gaoxin New Economy Venture Capital, Pengzhou Global Biomedical Technology Achievement Transformation…
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PrimeLink Bio Raises Funds for ADC Development and R&D Expansion
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Shenzhen-based drug developer PrimeLink Bio has reportedly raised “hundreds of millions” of renminbi in a new financing round led by Vertex Ventures. Fosun Pharma and Kaitai Capital also participated in the round. The proceeds will be used to support technology research and development (R&D), talent recruitment, and laboratory construction. Company…
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Kelun Pharma’s SKB264 Advances to Phase II Study for NSCLC
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that its antibody drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has obtained approval from the National Medical Products Administration (NMPA) to enter a Phase II clinical study in advanced or metastatic non-small cell lung cancer (NSCLC). The…
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Kelun-Biotech’s SKB264 Receives FDA Approval for Phase II Study
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd has announced receiving approval from the US FDA to conduct a Phase II clinical study for its drug candidate SKB264, an antibody drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), in combination with the PD-1 inhibitor pembrolizumab. The initial development target is selected…
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LaNova Medicines Gets NMPA Approval for LM-305 Clinical Study
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Shanghai-based cancer therapy developer LaNova Medicines Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its antibody drug conjugate (ADC) LM-305, targeting GPRC5D. This marks a significant milestone for LaNova as it advances its innovative ADC into clinical…
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Novatim Immune Therapeutics Raises RMB 500M in First Financing Round
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China-based tumor immunotherapy developer Novatim Immune Therapeutics (Zhejiang) Co., Ltd. has reportedly raised close to RMB 500 million (USD 68.9 million) in its first financing round. The round was led by Kequan Fund in the Anji County Economic Development Zone. The proceeds will be used for core product clinical studies,…
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Dartsbio Licenses Potential First-in-Class BsAb DS005 to Duality Biologics
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China-based Dartsbio Pharmaceuticals, Ltd has announced a licensing deal with Duality Biologics, a novel modality drug developer operating out of the United States and China. The agreement grants Duality Biologics global rights to Dartsbio’s in-house developed, potential first-in-class bispecific antibody (BsAb) DS005 to develop a new antibody drug conjugate (ADC).…
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Zhejiang Medicine’s ARX788 Advances to Phase II Study for HER2-Positive Cholangiocarcinoma
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China-based Zhejiang Medicine Co., Ltd (SHA: 600216) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the efficacy and safety of its ARX788, an anti-HER2 monoclonal antibody conjugate with AS269, in patients with HER2-positive cholangiocarcinoma. This approval marks a significant step…
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Innovent’s CLDN18.2 ADC IBI343 Begins Phase I Trial in Australia
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Innovent Biologics Inc. (HKG: 1801) has announced the first subject dosing in a Phase I clinical study for its IBI343, a CLDN18.2 antibody drug conjugate (ADC), in Australia. This marks the first ADC from the Chinese biotech company to enter clinical trials. Phase I Clinical Study DesignThe open-label, multi-center Phase…
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Alphamab Oncology Gains NMPA Approval for JSKN003 Clinical Trial
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Alphamab Oncology (HKG: 9966) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ia/Ib clinical study for its JSKN003. The study will assess the safety and tolerability of JSKN003 in patients with advanced malignant solid tumors and determine the maximum tolerable dose…
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CSPC’s Antibody-Drug Conjugate SYS6002 Gains CDE Approval for Clinical Study
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China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for SYS6002, an antibody-drug conjugate (ADC) developed in-house by its subsidiary CSPC Jushi Biopharmaceutical Co., Ltd. The intended indication for SYS6002 is advanced solid…
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Daiichi Sankyo Initiates Global Phase II Study of DS7300 for Small-Cell Lung Cancer
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Japan-based Daiichi Sankyo Inc. (TYO: 4568) has announced the first patient dosing in a global pivotal Phase II clinical study (S7300-127) assessing the efficacy and safety of its DS7300 (DS7300a), a potential first-in-class antibody drug conjugate (ADC), in patients with extensive small-cell lung cancer (SCLC) in China. DS7300 is an…
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Hengrui Medicine Gains Approval for Phase Ib/II Study of SHR-A1811 and SHR-1701 in HER2-Positive Gastric Cancer
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced receiving approval to initiate a Phase Ib/II clinical study in China for its SHR-A1811 combined with SHR-1701 in patients with HER2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ). This approval marks a significant step forward in the development of…
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Ambrx Biopharma Halts Development of HER2 ADC ARX788, Cuts Workforce
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US-based, China-owned biotech Ambrx Biopharma Inc. (NYSE: AMAM) has announced plans to end the development of its HER2-targeted antibody drug conjugate (ADC) pipeline candidate ARX788. The decision follows a strategic assessment of factors including cash runway, pipeline near-term value creation opportunities, and other considerations. As a result, the company also…
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Luye Pharma’s Shandong Boan Partners with Shanghai Pharmaceutical for Biologics Manufacturing
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China-based Luye Pharma Group (HKG: 2186) has announced that its controlling subsidiary, Shandong Boan Biotechnology Co., Ltd, has entered into a partnership with compatriot firm Shanghai Pharmaceutical Group (Benxi) North Pharmaceutical Co., Ltd. The collaboration will focus on the manufacturing of biologic drugs. Financial details of the partnership were not…
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Zai Lab Licenses Seagen’s Tivdak for Greater China Development and Commercialization
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Chinese firm Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has formed a collaboration with US-based biotech Seagen Inc. (Nasdaq: SGEN) to license development and commercialization rights in Greater China (including mainland China, Hong Kong, Taiwan, and Macau) to Tivdak (tisotumab vedotin). This strategic partnership aims to bring this innovative antibody-drug…
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Lepu Biotechnology’s MRG003 Receives Orphan Drug Designation from FDA
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China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received orphan drug designation (ODD) status from the US FDA for its core product MRG003, an epidermal growth factor receptor targeted antibody drug conjugate (ADC) for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). Drug Mechanism and DevelopmentMRG003…
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Northeast Pharmaceutical to Invest in Shanghai Subsidiary for ADC and CAR-T Development
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China-based Northeast Pharmaceutical Co., Ltd (SHE: 000597) has announced plans to invest RMB 500 million ($71 million) in establishing a wholly-owned subsidiary in Shanghai. The new entity is designed to accelerate the implementation of in-licensed antibody drug conjugates (ADCs) and chimeric antigen receptor (CAR)-T cell therapies, following a recent ADC-focused…
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Alphamab Oncology Doses First Patient in Phase I Study for JSKN003 in Australia
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Alphamab Oncology (HKG: 9966) has announced that the first patient has been dosed in a Phase I clinical study for its JSKN003-KN026 antibody drug conjugate (ADC) in Australia. The open, multi-center, dosage escalation Phase I study is designed to assess the safety, tolerability, and preliminary efficacy of JSKN003 in advanced…
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CDE Issues Guidelines for Anti-Tumor ADC Clinical Development
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The Center for Drug Evaluation (CDE) has released the “Technical Guidelines for Clinical Research and Development of Anti-Tumor Antibody Drug Conjugates” and is seeking public feedback for one month. The document aims to provide a framework for the rational design of clinical trials involving antibody drug conjugates (ADCs) for anti-tumor…
