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The China’s Center for Drug Evaluation (CDE) website has indicated that Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd’s (HKG: 6990) drug candidate, SKB264, is on track to obtain priority review status for the treatment of unresectable, locally advanced, or metastatic triple negative breast cancer (TNBC) in China. This development is particularly significant…
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Germany-based Merck KGaA (NYSE: MRK) has announced the signing of a strategic collaboration deal with China’s Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276). This agreement grants Merck development, manufacturing, and commercial rights to the next-generation PARP1 inhibitor HRS-1167 for all global territories outside of China. Additionally, Merck has an option…
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has announced that it has received approval from the National Medical Products Administration (NMPA) in China to conduct separate clinical studies for HLX42 and HLX43. These two pipeline candidates are antibody drug conjugates (ADCs) co-developed by subsidiary Shanghai Henlius Biotech Inc., (HKG:…
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted the market filing for its antibody drug conjugate (ADC) Elahere (mirvetuximab soravtansine), targeting folate receptor α (FRα). This marks a significant step towards making the treatment available for patients in China. Acquisition…
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The European Commission (EC) has granted registration approval for the HER2-directed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) to AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568). This approval is for the treatment of advanced HER2-positive non-small cell lung cancer (NSCLC) in adults who require systemic therapy following chemotherapy. The…
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) and its innovative drug development subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) have announced that their US partner Merck, Sharp & Dohme (MSD; NYSE: MRK) has decided to cancel the development of one pre-clinical antibody drug conjugate (ADC) and will not…
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China-based Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd (HKG: 1349; SHA: 688505) has announced that the National Medical Products Administration (NMPA) has accepted a Phase I clinical trial filing for its investigational drug FZ-AD005 in advanced solid tumors. This marks a significant step forward in the development of novel cancer therapies in…
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has entered into a licensing agreement with UK pharmaceutical giant GSK (NYSE: GSK), granting GSK development, manufacturing, and commercialization rights to its pipeline antibody drug conjugate (ADC) HS-20089 for all global territories outside Greater China. HS-20089: Targeting B7-H4 in OncologyHS-20089 is an…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a strategic collaboration agreement with Japan-based Daiichi Sankyo (TYO: 4568) focused on the development and commercialization of three potential first-in-class deruxtecan-based antibody-drug conjugate (ADC) candidates. This partnership aims to advance innovative treatments for various types of cancer. ADC Candidates and Development…
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WuXi XDC, a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259), has entered into a strategic cooperation framework agreement with Hong Kong Science and Technology Parks Corp. The partnership aims to promote the establishment of a Contract Research, Development,…
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US pharmaceutical company Eli Lilly (NYSE: LLY) has signed an agreement to acquire France-based Mablink Bioscience, a biotechnology firm specializing in next-generation antibody-drug conjugates (ADCs). This strategic move is set to enhance Eli Lilly’s capabilities in developing innovative oncology treatments through Mablink’s advanced ADC technology. Mablink’s Proprietary ADC TechnologyMablink Bioscience’s…
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German pharmaceutical giant Merck KGaA (ETR: MRK) has entered into a strategic partnership with China-based Contract Development and Manufacturing Organization (CDMO) Porton Pharma Solutions’ Shanghai unit. The collaboration aims to develop a next-generation integrated antibody drug conjugate (ADC) platform technology, marking a significant step in the advancement of oncology treatments.…
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China-based Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has announced that it will present the latest clinical data for its investigational drugs 9MW2821 and 8MW0511 at the upcoming 2023 European Society for Medical Oncology (ESMO) Congress. This presentation underscores the company’s commitment to advancing innovative therapies in oncology. 9MW2821: Promising…
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China-based pharmaceutical innovator Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) and its subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) are preparing to present the results of a Phase I/II basket study for their drug SKB264 (MK-2870) at the 2023 European Society for Medical Oncology (ESMO) Congress. The study focuses…
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China-based biopharma RemeGen Ltd (HKG: 9995) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), in patients with breast cancer. First Home-Grown ADC with Conditional Approvals Disitamab vedotin stands…
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Suzhou-based Medilink Therapeutics has announced a strategic cooperation and global licensing agreement with Germany-headquartered BioNTech SE (NASDAQ: BNTX). Under this partnership, the two companies will collaborate to develop next-generation antibody drug conjugates (ADCs) targeting the human epidermal growth factor receptor 3 (HER3). Leveraging TMALIN Technology for Enhanced Efficacy The ADC…
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Eli Lilly (NYSE: LLY) has announced the initiation of three innovative oncology programs focusing on KRAS and Nectin-4, all of which are currently in the pre-clinical stage. This strategic move highlights Lilly’s commitment to advancing cancer therapies that target specific oncogenic pathways. Details of the New Oncology Programs The new…
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China-based Contract Development and Manufacturing Organization (CDMO) ZhenGe Biotech has announced a strategic partnership with domestic firm Glyco-Therapy. This collaboration aims to create a comprehensive resource cooperation and service platform for the development of next-generation antibody drug conjugates (ADCs). Innovative Approach to ADC Development The partnership will focus on the…
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Hangzhou HealSun Biopharm Co., Ltd., a Chinese contract research organization (CRO) and contract development and manufacturing organization (CDMO) specializing in antibodies and recombinant proteins, has successfully raised nearly RMB 200 million (approximately USD 27.8 million) in a Series B+ financing round. The funding was led by China Medical System Holdings…
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China-based RemeGen Ltd (HKG: 9995) is poised to conduct a Phase II clinical study in collaboration with fellow Chinese firm Akeso Biopharma (HKG: 9926). The study will assess the combination of RemeGen’s antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), with Akeso’s bispecific antibody, cadonilimab (AK104), for the treatment of gastric…