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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…
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AstraZeneca Partners with Cellectis for Next-Generation Cell and Gene Therapies
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UK pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has announced a strategic partnership with Cellectis (EPA: ALCLS; NASDAQ: CLLS) to develop next-generation therapeutics, focusing on areas of high unmet need such as oncology, immunology, and rare diseases. This collaboration aims to leverage Cellectis’s gene editing technologies and manufacturing capabilities to advance…
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Daiichi Sankyo Reports 19.5% YOY Revenue Growth in First Half of Fiscal 2023
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Japan’s Daiichi Sankyo (TYO: 4568) reported a robust 19.5% year-on-year (YOY) increase in revenue for the six months ended September 30, 2023, reaching JPY 726.3 billion (USD 4.8 billion), according to the company’s financial report published this week. This growth was driven by a combination of factors, including the depreciation…
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Chongqing Precision Biotechnology’s PCAR-19B Receives CDE Nod for Breakthrough Therapy Designation
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The China’s Center for Drug Evaluation (CDE) website has indicated that Chongqing Precision Biotechnology Co., Ltd’s PCAR-19B cell autologous reinfusion preparation is on track to receive breakthrough therapy designation (BTD). This designation recognizes the potential of PCAR-19B as a treatment for patients aged 3 to 21 years old with CD19-positive…
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Sichuan Kelun-Biotech’s SKB264 Receives Priority Review Status for TNBC Treatment in China
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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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Hinova Pharmaceuticals’ HP518 Receives NMPA Approval for mCRPC Clinical Trial
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China-based biopharmaceutical company Hinova Pharmaceuticals (SHA: 688302) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) in China for its drug candidate HP518, which is being developed to treat metastatic castration-resistant prostate cancer (mCRPC). The androgen receptor (AR)-targeted PROteolysis TArgeting Chimera (PROTAC) drug…
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3SBio Inc. and CStone Pharmaceuticals Enter Strategic Partnership for Nofazinlimab
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China-based 3SBio Inc., (HKG: 1530) has announced a strategic partnership and exclusive licensing agreement with compatriot firm CStone Pharmaceuticals (HKG: 2616), focusing on CStone’s anti-programmed death-1 (PD-1) antibody, nofazinlimab. This partnership signifies a significant expansion in the immuno-oncology space for both companies. Financial Terms and Agreement DetailsUnder the terms of…
