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China-based biopharmaceutical company BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced a licensing agreement with Ensem Therapeutics Inc., a biopharma company incubated by CBC Group and operating in Massachusetts, US, and Shanghai, China. According to the agreement, BeiGene will obtain an exclusive global license to Ensem’s oral cyclin-dependent…
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Shanghai-based Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196; SHA: 600196) has announced that the National Medical Products Administration (NMPA) has accepted for review its market approval filing for FCN-437c. The small molecule drug candidate is under development for the treatment of hormone receptor (HR) positive and human epidermal growth factor…
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Glumetinib, a MET targeted tyrosine kinase inhibitor (TKI) co-developed by CSPC Pharmaceutical Group Ltd (HKG: 1093) and Shanghai Haihe Pharmaceutical Co., Ltd, has been granted breakthrough therapy designation (BTD) by the Center for Drug Evaluation (CDE) in China. The drug is indicated for locally advanced or metastatic non-small cell lung…
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Suzhou-based Medilink Therapeutics has announced that it has obtained orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its antibody-drug conjugate (ADC) YL201, which is being developed to treat esophageal cancer (EC). YL201, a B7H3-targeted ADC product, is based on Medilink’s Tumor Microenviroment Activable LINker (TMALIN)…
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has achieved its latest global approval for the Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The European Commission has approved Brukinsa in combination with obinutuzumab (Roche’s CD20-targeted Gazyva) as a third-line treatment for relapsed or refractory (R/R) follicular lymphoma (FL). This marks…
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Shanghai-based Usynova Pharmaceuticals Ltd has announced a licensing agreement with UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) concerning its pipeline candidate, UA022. UA022 is a small-molecule drug targeting the KRASG12D mutation, currently in the pre-clinical stages of development. Terms of the Agreement and FinancialsUnder the agreement, AstraZeneca (AZ) will secure…
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China-based Ascentage Pharma (HKG: 6855) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Category 1 drug, olverembatinib. This second market-approved indication is for the treatment of adult patients with chronic myeloid leukemia (CML) in the chronic phase (CP) who are resistant and/or intolerant…
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US-based biotech Apollomics Inc., (NASDAQ: APLM) has announced that its Chinese partner, Avistone Biotechnology Co., Ltd, has received conditional market approval for the c-Met inhibitor vebreltinib from the National Medical Products Administration (NMPA). The approval is for the treatment of patients with MET exon 14 skipping non-small cell lung cancer…
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has announced receiving clinical trial approvals for its VT-101 from both the National Medical Products Administration (NMPA) in China and the US Food and Drug Administration (FDA). VT-101 is a next-generation recombinant oncolytic adenovirus product that features a triple-targeted tumor regulation mechanism,…
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China-based health services and distribution giant Baheal Pharmaceutical Group has struck a commercialization partnership with Guangdong Ruidio Technology Co., Ltd. Under the terms of the agreement, Baheal acquires commercialization rights to Ruidio’s series of radioactive drugs, including 99mTc-3PRGD2, 99mTc-HP-Ark2, and 99mTc-POFAP, as well as imaging equipment products such as SPECT.…
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Partners Pfizer (NYSE: PFE) and Astellas Pharma (TSE: 4503) last week received indication extension approval from the US Food and Drug Administration (FDA) for their androgen receptor signaling inhibitor Xtandi (enzalutamide). The drug is now approved as a treatment for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high…
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UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received regulatory approval from the US Food and Drug Administration (FDA) for its first-in-class AKT inhibitor, Truqap (capivasertib), in combination with fulvestrant. This treatment is indicated for HR-positive, HER2-negative locally advanced or metastatic recurrent or refractory breast…
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Alphamab Oncology (HKG: 9966) has released preliminary data from a Phase I clinical study on its JSKN003-KN026 antibody drug conjugate (ADC) in Australia, focusing on advanced solid tumors. This open-label, multi-center, dosage escalation study is designed to evaluate the safety, tolerability, and preliminary efficacy of the molecule in treating these…
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS, NYSE: BMY) registration approval for its next-generation tyrosine kinase inhibitor (TKI) Augtyro (repotrectinib) for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults. This decision follows a priority review of Phase…
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Japan’s Astellas Pharma (TYO: 4503) has announced the negotiation of a purchase agreement for US biopharmaceutical company Propella Therapeutics this week, with a transaction value of USD 175 million. The deal is anticipated to be finalized by March 2024, subject to the fulfillment of customary conditions. With this acquisition, Astellas…
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The Nuclear Regulatory Commission (NRC) of the US has given its approval for the transfer of a radioactive materials license from Point Biopharma (NASDAQ: PNT) to Eli Lilly (NYSE: LLY). This decision marks the final regulatory clearance necessary for Eli Lilly’s acquisition of Point Biopharma, which was announced last month.…
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Germany’s Merck KGaA (ETR: MRK), a leading player in the global pharmaceutical industry, has this week unveiled its strategic plans for the US healthcare market. The company, which currently commercializes two cancer treatments in the US, is gearing up to launch two additional drugs by 2025. Furthermore, Merck anticipates continuing…
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The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has issued a positive opinion regarding the approval of Tecentriq SC (atezolizumab), the subcutaneous version of Roche’s (SWX: ROG) PD-L1 inhibitor Tecentriq. This development is a significant step forward for patients with various types of…
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China-based Legend Biotech Corp., (NASDAQ: LEGN) has secured a second multinational partnership for its chimeric antigen receptor (CAR) T cell therapies with Novartis Pharma AG (NYSE: NVS) in a landmark USD 1.1 billion deal. The Swiss pharmaceutical giant has acquired exclusive global development, manufacturing, and commercialization rights to certain assets…
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Bristol Myers Squibb (BMS; NYSE: BMY) has made a significant move in the field of oncology by purchasing ORM-6151, a potential first-in-class antibody-drug conjugate (ADC) from US-based Orum Therapeutics. The acquisition includes approval from the local regulator for ORM-6151 to enter a Phase I study for acute myeloid leukemia (AML)…