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Abbisko Therapeutics Receives FDA Approval for Phase I Study of FGFR4 Inhibitor ABSK012
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Shanghai-based biotech company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received clearance from the US Food and Drug Administration (FDA) to commence a Phase I clinical study of its next-generation FGFR4 mutant inhibitor, ABSK012, for the treatment of advanced solid tumors. Objectives of the Phase I…
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FibroGen Inc. Reports 155% YOY Sales Increase in Q3 2023 Financial Results
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US-based biotechnology company FibroGen Inc., (NASDAQ: FGEN) has reported its financial results for the third quarter of 2023, showcasing a significant year-on-year (YOY) increase in global sales. The company’s revenues rose by 155% to USD 40.1 million, reflecting the success of its anti-anemia drug for chronic kidney disease (CKD), Evrenzo…
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Gilead Sciences and Arcus Biosciences Announce Positive Phase II Data for Domvanalimab Combination Therapy
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Gilead Sciences (NASDAQ: GILD) and Arcus Biosciences (NYSE: RCUS) have this week released preliminary data from a Phase II study combining Gilead’s anti-TIGIT biologic domvanalimab with Arcus’ anti-PD-1 drug zimberelimab plus chemotherapy for the treatment of locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. The study marks…
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SciClone Pharmaceuticals Secures Exclusive Rights to Menarini Group’s Orserdu in China
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China’s SciClone Pharmaceuticals Inc., (HKG: 6600) has entered into a licensing and cooperation agreement with the Italy-headquartered Menarini Group. This agreement grants SciClone exclusive development and commercialization rights to Menarini’s Orserdu (elacestrant) in China. SciClone will be responsible for conducting clinical trials, regulatory filings, and marketing and distribution of Orserdu…
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RinuaGene Receives US FDA IND Approval for HPV-Associated Tumor mRNA Vaccine RG002
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RinuaGene, a leading mRNA specialist headquartered in Suzhou, has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its human papillomavirus (HPV) associated tumor therapeutic mRNA vaccine, RG002. This marks a significant step forward in the development of the vaccine,…
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Enhertu Receives Priority Review Status for HER2-Positive Gastric Cancer Treatment in China
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The Center for Drug Evaluation (CDE) website has indicated that Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), is set for priority review status in China. This priority review is specifically for the ADC’s potential use as a…
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BioNTech Secures Exclusive Rights to Biotheus Inc.’s BsAb PM8002 in Landmark Deal
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Germany’s BioNTech (NASDAQ: BNTX) has entered into an exclusive license and collaboration agreement with China-based Biotheus Inc., focusing on the development and commercialization of the bispecific antibody (BsAb) PM8002. The deal grants BioNTech development, manufacturing, and commercial rights to PM8002 in all markets outside of Greater China, marking a significant…
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Seagen’s Adcetris Combo with Keytruda Shows Promising Results in Phase II Study
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Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), has released the results of a Phase II study combining its antibody drug conjugate (ADC) Adcetris (brentuximab vedotin) with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 therapy Keytruda (pembrolizumab). The study focused on patients with…
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Zhejiang Huahai Pharmaceutical’s HB0052 Receives US FDA IND Approval for Solid Tumors
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IntroductionZhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its injectable drug candidate, HB0052. The drug will initially be assessed in general advanced solid tumors, marking a significant…
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BeiGene’s ZW25 on Track for Priority Review for Cholangiocarcinoma Treatment by CDE
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The Center for Drug Evaluation (CDE) website has indicated that BeiGene’s (NASDAQ: BGNE) ZW25 (zanidatamab) is set to receive priority review status for the treatment of unresectable locally advanced or metastatic cholangiocarcinoma in patients with high HER2 expression who have previously received systemic treatment. This priority review status is a…
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CSPC Pharmaceutical Group Gets NMPA Approval for SYS6011 Biologic Drug Clinical Study
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a China-based pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 biologic drug candidate, SYS6011. The study will be focused on general solid tumors, marking a significant step…
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Bayer Extends Collaboration with Broad Institute to 2028 for Oncology Drug Targets and Therapies
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Germany’s Bayer (NYSE: ETR) has announced the extension of its 2013 collaboration agreement with the US-based research center, the Broad Institute, until 2028. The partnership focuses on identifying new drug targets in oncology and developing innovative cancer therapies. The financial details of the extended agreement have not been disclosed. Combining…
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Gaush Meditech Ltd Receives NMPA Approval for Rigid Corneal Contact Lens
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Gaush Meditech Ltd (HKG: 2407), a company based in Suzhou, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its rigid corneal contact lens. This development marks a significant step forward for the company, as it now offers a highly rigid gas permeable…
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Amoy Diagnostics Receives NMPA Approval for MSI Detection Kit as Companion Diagnostic for Immunotherapy
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Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a prominent player in the Chinese diagnostics industry, has announced that it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its human microsatellite instability (MSI) detection kit. This kit, which utilizes fluorescent PCR capillary electrophoresis,…
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Wuhan Hiteck Biological Pharma Receives NMPA Approval for Aponermin in Multiple Myeloma Treatment
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Wuhan Hiteck Biological Pharma Co., Ltd (SHE: 300683), a Chinese biopharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Aponermin. This approval is for the treatment of adult patients with recurrent or refractory multiple myeloma who have previously undergone…
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Abbisko Therapeutics to Present CSF-1R Inhibitor ABSK021 Data at CTOS Annual Meeting
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it will present data from two clinical studies on its next-generation CSF-1R inhibitor, ABSK021 (pimicotinib), at the Connective Tissue Oncology Society (CTOS) annual meeting. The presentations will highlight significant findings from the Phase Ib clinical study and the ongoing…
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Ascentage Pharma’s Olverembatinib Showcases Promising Results at ASH Annual Meeting
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Suzhou-based Ascentage Pharma (HKG: 6855) has presented the latest results of multiple studies regarding its innovative drug candidate olverembatinib at the 65th American Society of Hematology (ASH) annual meeting. The data highlights the potential of olverembatinib in treating various hematological malignancies, including chronic myeloid leukemia (CML) and Philadelphia-positive acute lymphoblastic…
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I-Mab and HI-Bio’s Felzartamab Earns Breakthrough Therapy Designation from US FDA
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China-based I-Mab (NASDAQ: IMAB) and its US partner HI-Bio have announced that they have received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for their CD38 monoclonal antibody (mAb), felzartamab. This designation highlights the drug’s potential as a treatment for primary membranous nephropathy (PMN), a rare…
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Eli Lilly & Co. Reports 36% YOY Sales Growth in Q3 2023 with Key Drug Performances
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Eli Lilly & Co., (NYSE: LLY) has announced its financial results for the third quarter of 2023, showing a 36% year-on-year (YOY) increase in sales to USD 9.5 billion in constant currency terms. This figure includes a USD 1.42 billion one-off payment from the sale of the Zyprexa (olanzapine) portfolio…
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Pfizer Inc. Reports Q3 2023 Revenue Contraction and Launches Cost Realignment Program
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US pharmaceutical giant Pfizer Inc., (NYSE: PFE) has released its financial results for the third quarter of 2023, reporting a contraction of -41% year-on-year (YOY) in operational terms to USD 13.2 billion, excluding foreign currency fluctuations. The quarter was marked by a net loss of USD 2.38 billion, the company’s…
