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MSD’s Belzutifan and Sperogenix’s Vamorolone Targeted for Priority Review by China’s CDE
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The Center for Drug Evaluation (CDE) website has indicated that Merck, Sharp & Dohme’s (MSD; NYSE: MRK) belzutifan and Sperogenix Therapeutics Ltd’s vamorolone are on track to receive priority review statuses in China. Belzutifan, which targets von Hippel Lindau (VHL) disease-associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastoma,…
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AstraZeneca Secures Shareholder Approval for $1 Billion Acquisition of Gracell Biotechnologies
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The proposed acquisition of China-based Gracell Biotechnologies Inc. (Nasdaq: GRCL) by UK pharmaceuticals giant AstraZeneca (AZ, NASDAQ: AZN) has received approval from Gracell’s shareholders during an extraordinary general meeting held on February 19, 2024. An overwhelming 99.9% of shareholders voted in favor of AstraZeneca’s $1 billion acquisition, with potential total…
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BMS Seeks FDA Priority Review for Krazati in Advanced Colorectal Cancer
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Bristol Myers Squibb (BMS; NYSE: BMY) has submitted a priority review application to the U.S. Food and Drug Administration (FDA) for an additional indication of its KRASG12C inhibitor, Krazati (adagrasib), in combination with cetuximab (Merck’s Erbitux) for pre-treated patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC). The FDA…
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WuXi ATU’s Philadelphia Facility Approved for Amtagvi Production Following FDA Nod
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WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec (SHA: 603259, HKG: 2359) based in China, has announced the U.S. FDA’s approval of its Philadelphia facility to commence analytical testing and manufacturing of Amtagvi (lifileucel) for Iovance. This novel therapy received accelerated approval for its Biologics License…
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HitGen’s Vernalis Partners with Hox Therapeutics to Develop Novel Cancer Inhibitors
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HitGen Inc. (SHA: 688222), based in China, announced that its wholly owned subsidiary Vernalis (R&D) Ltd will collaborate with Hox Therapeutics Ltd, a private biotech firm dedicated to developing highly targeted cancer therapies, to create inhibitors aimed at undisclosed targets. Vernalis will leverage its advanced protein science capabilities and Hit…
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Merck’s Keytruda Under Priority Review for New Indication in Endometrial Carcinoma
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This week, the U.S. FDA granted priority review status to an indication extension filing from Merck, Sharp & Dohme (MSD; NYSE: MRK) for its blockbuster drug Keytruda (pembrolizumab), seeking approval as a treatment for primary advanced or recurrent endometrial carcinoma, the most prevalent gynecological cancer. The FDA anticipates reaching a…
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Immune-Onc Therapeutics Partners with Roche for Phase Ib/II Study of IO-108 in Liver Cancer
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Immune-Onc Therapeutics Inc., based in the U.S., is entering into a collaboration with Roche (SWX: ROG) to conduct a Phase Ib/II clinical study evaluating its LILRB2 (ILT4) monoclonal antibody (mAb) IO-108 in combination with Roche’s PD-L1 mAb atezolizumab and VEGF mAb bevacizumab. This study aims to target first-line localized advanced,…
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Innovent Biologics Partners with ImmVirX to Launch Clinical Study Combining Tyvyt and IVX037
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Innovent Biologics Inc. (HKG: 1801), based in China, has announced the signing of a clinical study and supply cooperation agreement with ImmVirX Pty Ltd. This strategic partnership will facilitate a clinical study that combines Innovent’s Tyvyt (sintilimab), a programmed death-1 (PD-1) inhibitor already approved in China for seven different indications,…
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Mabwell Bioscience Receives FDA Green Light for B7-H3 Targeting ADC 7MW3711
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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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BMS and Sichuan Biokin Commence Joint Development of EGFR/HER3-Targeted ADC
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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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Jacobio Pharma Gets CDE Green Light for Phase III Study Combining Gleevec Inhibitors in NSCLC
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Jacobio Pharma (HKG: 1167), a China-based pharmaceutical company, has announced that it has received approval from the Center for Drug Evaluation (CDE) in China to initiate a regulatory Phase III clinical study. The study will assess the combination of its KRAS G12C inhibitor glecirasib with pipeline SHP2 inhibitor JAB-3312 for…
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Phanes Therapeutics’ PT886 Receives CDE Approval for Clinical Trials in Advanced Solid Tumors
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Sino-US biotechnology company Phanes Therapeutics Inc. has announced that it has received clinical trial approval from China’s Center for Drug Evaluation (CDE) for its first-in-class claudin 18.2/CD47 bispecific antibody (BsAb) PT886, intended for the treatment of advanced solid tumors including gastric cancer, gastroesophageal junction cancer, and pancreatic cancer. PT886, a…
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ImmunoTech Biopharm Gets NMPA Green Light for Clinical Study of aT19 Injection for B-ALL
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ImmunoTech Biopharm Ltd (HKG: 6978), a specialist in chimeric antigen receptor T-cell (CAR-T) therapies based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its aT19 injection. The treatment is designed as a sequential therapy for patients…
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GSK’s Avodart Receives NMPA Approval to Resume Sales in China from September
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The National Medical Products Administration (NMPA) has released a notification announcing that GlaxoSmithKline’s (GSK) Avodart (dutasteride) has been given the green light to resume import, sales, and use in China, effective from September 1, 2023. This follows a previous suspension due to an unsuccessful overseas site inspection by the NMPA…
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AstraZeneca Reports 6% Revenue Growth in 2023, Driven by Oncology and Diabetes Drug Sales
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AstraZeneca (AZ; NASDAQ: AZN), the UK-based multinational, reported its financial results for 2023 this week, revealing a 6% year-on-year increase in annual global revenues, reaching USD 45.8 billion at constant exchange rates. Oncology revenue surged by 21%, while cardiovascular, renal, and metabolism (CVRM) sales rose 18%. Respiratory and immunology (R&I)…
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AbbVie Expands Licensing Agreement for Innovative sCAR-T Platform with Scripps Research
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AbbVie (NYSE: ABBV) has expanded its collaboration with Scripps Research’s Calibr-Skaggs Institute, securing licensing rights to the institute’s investigational switchable CAR-T (sCAR-T) platform, which has shown promising early-stage results. The agreement entails an upfront payment, along with potential milestone payments and royalties, allowing AbbVie to access the program for up…
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CMS Secures NMPA Approval for Clinical Trials of TYK2 Inhibitor CMS-D001 and GnRH Antagonist CMS-D002
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China Medical System Holdings Ltd (CMS, HKG: 0867) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for two of its drug candidates: CMS-D001 and CMS-D002. CMS-D001 is a highly selective TYK2 (tyrosine kinase 2) inhibitor aimed at treating immune inflammatory diseases, including…
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Yantai Dongcheng Acquires Full Rights to Alfatide II, Targeting Diagnostic and Therapeutic Applications
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Yantai Dongcheng Pharmaceutical Group Co., Ltd. (SHE: 002675) has announced its acquisition of all rights to alfatide II across all diagnostic and therapeutic fields and indications. Alfatide II, initially developed by Dr. Chen Xiaoyuan and previously licensed to Jiangsu Xinrui Pharmaceutical Co., Ltd. for further development, is currently in the…
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Gilead’s 2023 Flat Sales Reflect Stagnation and COVID-19 Demand Decline
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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%…
