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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received approval from the National Medical Products Administration to conduct a Phase Ib/II study for its antibody drug conjugate (ADC) BAT8008 in combination with BAT1308 for the treatment of advanced solid tumors. BAT8008 is an innovative ADC that consists of…
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Lepu Biotechnology Co., Ltd. (HKG: 2157), based in China, has announced that its in-house developed antibody-drug conjugate (ADC) MRG004A has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. This indication previously secured the ADC an orphan drug designation (ODD)…
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Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) has officially activated its licensing and cooperation agreement with U.S. pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY) for the development of Biokin’s BL-B01D1 antibody-drug conjugate (ADC) candidate, effective February 8, 2024. As of March 7, the company confirmed receipt of the USD 800…
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The Center for Drug Evaluation (CDE) website has indicated that DB-1303, a HER2 targeted antibody drug conjugate (ADC) developed by Duality Biologics, a biotech company with operations in both the United States and China, is poised to receive breakthrough therapy designation (BTD). The proposed use for the treatment is for…
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China-based Apeloa Pharmaceutical Co., Ltd (SHE: 000739) has entered into a strategic partnership with domestic Contract Development and Manufacturing Organization (CDMO) ZhenGe Biotech. The collaboration aims to establish an antibody drug conjugate (ADC) platform that offers a range of diversified antibodies, highly active small molecule payloads, and linker technology. The…
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The European Medicines Agency (EMA) has accepted for review two oncology filings for the antibody-drug conjugate (ADC) datopotamab deruxtecan, developed jointly by UK-based AstraZeneca (AZ; NASDAQ: AZN) and Japan’s Daiichi Sankyo (TYO: 4568). The indications submitted for review are for the treatment of locally advanced or metastatic nonsquamous non-small cell…
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Jiangsu Hengrui Pharmaceutical Co., Ltd (SHA: 600276) has secured clinical trial approval from the National Medical Products Administration (NMPA) for its investigational therapy HRS-1167, which will be evaluated in combination with SHR-A1921, bevacizumab, or abiraterone plus prednisone/prednisolone for the treatment of advanced solid tumors. HRS-1167 is a second-generation PARP inhibitor…
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The Center for Drug Evaluation (CDE) has announced that Jiu An Pharmaceutical’s adrenaline and AnHeart Therapeutics’ taletrectinib are set for priority review, while Biotheus Inc.’s PM8002 and Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422)’s SKB264 have been designated as breakthrough therapies (BTDs). Adrenaline is gaining priority status due to new…
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Harbour BioMed (HKG: 2142), a biotechnology company with operations in Suzhou, China, Cambridge in the US, and the Netherlands, has announced an antibody drug conjugate (ADC) discovery cooperation agreement with South Korea-based ADC specialist Boostimmune, Inc. The financial details of the agreement have not been disclosed. As per the terms…
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) has announced the initiation of clinical trials for SKB264 (MK-2870), an antibody-drug conjugate (ADC) co-developed with Merck, Sharp & Dohme (MSD, NYSE: MRK) for the treatment of non-small cell lung cancer (NSCLC) and endometrial carcinoma (EC). This development triggers a clinical milestone payment…
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received fast-track designation from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) 9MW2821. This candidate targets Nectin-4 and is under investigation for the treatment of advanced, recurrent,…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received Fast-Track Designation (FTD) from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) SHR-A1912, targeting CD79b, in the treatment of recurrent/refractory diffuse large B-cell lymphoma (R/R DLBCL) in…
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its antibody drug conjugate (ADC) 7MW3711, which targets B7-H3. The molecule is intended to be assessed…
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese pharmaceutical company, has announced that a licensing and cooperation agreement with US pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY) has officially come into effect as of February 8, 2024, following the expiration of the waiting period for the deal. The agreement…
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China’s Center for Drug Evaluation (CDE) has issued a notification outlining the “Guiding Principles for Pharmaceutical Research and Evaluation of Antibody Drug Conjugates (ADCs).” The document aims to standardize and guide the research, development, and regulatory submissions pertaining to ADCs. The guidelines are applicable to ADC products that are created…
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Gilead Sciences Inc. (NASDAQ: GILD) has reported a stagnant performance for the year 2023, with total product sales remaining unchanged at USD 26.9 billion. Amid a broad decline in demand for COVID-19 treatments, the company’s antiviral Veklury (remdesivir) sales could not offset the downturn, although HIV sales increased by 6%…
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Gilead Sciences (NASDAQ: GILD) has reported a stagnant performance for 2023, with product sales remaining flat at USD 26.9 billion. The company’s financials were affected by a widespread downturn in demand for COVID-19 treatments, as its antiviral Veklury (remdesivir) sales offset growth in other areas. HIV sales reached USD 18.2…
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Shanghai’s Sunshine Medical Procurement All-in-One (SMPA) platform has announced a significant policy shift regarding non-winning bids in the 9th round of volume-based procurement (VBP). The notification suggests that drugs which did not secure a winning bid and are eligible for online procurement in Shanghai may be exempted from the “high-priced…
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German biotechnology company BioNTech SE (NASDAQ: BNTC) and its partner Duality Biologics (Suzhou) Co., Ltd have received fast-track designation from the U.S. Food and Drug Administration for their jointly developed drug candidate DB-1305/BNT325. This designation is in recognition of the drug’s potential to treat platinum-resistant epithelial ovarian cancer, fallopian tube…
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The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J, NYSE: JNJ)’s Talvey (talquetamab) and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) are on track to receive priority review statuses. Talquetamab, a bispecific GPRC5D-directed CD3 T-cell engager, is in development for the treatment of adult patients with recurrent/refractory…