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Roche’s Alecensa Secures NMPA Approval as Adjuvant Therapy for Early-Stage NSCLC
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Roche (SWX: RO), the Swiss pharmaceutical giant, has announced that it has received an additional indication approval from the National Medical Products Administration (NMPA) for its drug Alecensa (alectinib). This new indication is for use as a post-surgery adjuvant therapy in patients with stage 1B to stage IIIA non-small cell…
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Hinova Pharmaceuticals’ HP537 Receives FDA Approval for Phase I/II Clinical Trial in Hematologic Malignancies
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Hinova Pharmaceuticals Inc. (SHA: 688302), a biotech company based in Chengdu, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I/II clinical study for its drug candidate HP537 in the treatment of hematologic malignancies. The Category 1 chemical had previously…
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Roche’s Tiragolumab Misses Primary Endpoints in NSCLC Trial, Study Halted
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Roche (SWX: ROG; SWX: RO; OTCMKTS: RHHBY), the Swiss pharmaceutical giant, has announced that a Phase II/III clinical trial for its TIGIT-targeted antibody tiragolumab, designed for non-small cell lung cancer (NSCLC), did not outperform Keytruda (pembrolizumab), a PD-1 inhibitor. The trial, known as SKYSCRAPER-06, was evaluating the efficacy of tiragolumab…
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Medigene AG Secures Chinese Patent for TCR-T Therapy Targeting NY-ESO-1 and LAGE 1a
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Medigene AG (ETR: MDG1), a biopharmaceutical company based in Germany, has announced that it has been granted patent protection in China for its T cell receptor (TCR) technology targeting NY-ESO-1 and LAGE 1a. This development pertains to the company’s lead pipeline candidate, MDG1015, which is a first-in-class, third-generation TCR-T therapy.…
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J&J’s Rybrevant Earns First-Line NSCLC Approval in Canada, a Milestone for EGFR Exon 20 Patients
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Johnson & Johnson (J&J; NYSE: JNJ) has announced that Rybrevant (amivantamab) has received its first market approval in Canada. The drug is approved as a first-line treatment in combination with chemotherapy for advanced or metastatic non-small cell lung cancer (NSCLC) in patients with activating epidermal growth factor receptor (EGFR) Exon…
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Ascentage Pharma Receives USD 100 Million Option Rights Payment from Takeda
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has announced that it has received a USD 100 million option rights payment from its Japanese partner Takeda (TYO: 4502), in accordance with an exclusive option agreement signed earlier last month. In June 2024, Takeda and Ascentage entered into an…
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HutchMed’s Tazverik for Follicular Lymphoma Accepted for Review by China’s NMPA
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HutchMed (NASDAQ: HCM), a China-based biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for Tazverik (tazemetostat) for review. The company is seeking initial approval for Tazverik as a treatment for recurrent or refractory follicular lymphoma (FL), and the filing has been…
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CStone Pharmaceuticals Partners with Hengrui for Promotion of Ayvakit in China
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CStone Pharmaceuticals (HKG: 2616), a biopharmaceutical company based in China, has announced a licensing agreement with Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), another Chinese pharmaceutical firm. The agreement grants Hengrui exclusive promotion rights to Ayvakit (avapritinib), CStone’s precision therapy, in mainland China. CStone maintains all rights to Ayvakit in…
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Astellas Pharma’s Xtandi Secures Third Market Approval in China for Prostate Cancer Treatment
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Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced that it has secured market approval in China for a new indication of its drug Xtandi (enzalutamide), marking its third such approval in the country. The drug is now approved for the treatment of metastatic hormone-sensitive prostate cancer…
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Jiangsu Vcare Pharma Partners with Geneseeq Technology to Develop Companion Diagnostic for NTRK Inhibitor
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Jiangsu Vcare PharmaTech Co., Ltd, a biopharmaceutical company based in China, has entered into a partnership with Sino-Canadian firm Geneseeq Technology Inc. The collaboration aims to jointly develop and commercialize a companion diagnostic (CDx) reagent for Vcare’s NTRK inhibitor VC004. Financial details of the agreement were not disclosed. Preliminary clinical…
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Bristol-Myers Squibb Ends Collaboration with Eisai on Farletuzumab Eteribulin
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Bristol-Myers Squibb (BMS; NYSE: BMY), a prominent US pharmaceutical company, has decided to terminate its collaboration with Japanese pharmaceutical firm Eisai Co., Ltd, which was focused on the co-development of Eisai’s antibody drug conjugate (ADC) farletuzumab ecteribulin (FZEC; MORAb-202). According to a press release from Eisai, BMS’s decision is part…
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Tracon Pharmaceuticals Halts Development of Envafolimab After Clinical Trial Failure
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Tracon Pharmaceuticals (OTCMKTS: TCON), a US-based biopharmaceutical company, has decided to cease development of its programmed death-ligand 1 (PD-L1) inhibitor, envafolimab, following disappointing results from a clinical trial. The company had obtained the rights to develop this molecule for soft-tissue sarcomas in North America through a 2019 agreement with China’s…
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SCG Cell Therapy Receives FDA Approval for HPV-Targeted SCG142 Clinical Trial
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SCG Cell Therapy Pte. Ltd, a Singapore-headquartered biotechnology company with a presence in Shanghai, has announced that it has received clearance from the US Food and Drug Administration (FDA) to proceed with a Phase I/II clinical study for its investigational therapy, SCG142. This therapy is a human papillomavirus (HPV) specific…
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Moon Biotech Secures Exclusive State-Owned Fund Investment in Series C+ Round
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Moon (Guangzhou) Biotech Co., Ltd, a leading microbiome platform company based in China, has reportedly secured RMB 300 million (USD 41.3 million) in a Series C+ financing round. The funding was exclusively provided by SDIC JULI Investment, a state-owned investment fund. Established in 2015, Moon is recognized for possessing the…
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China’s Henlius Biotech Partners with Sermonix for Japan Development of Breast Cancer Drug
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Shanghai Henlius Biotech Inc. (HKG: 2696), a prominent biopharmaceutical company based in China, has announced an expansion of its licensing agreement with Sermonix Pharmaceuticals Inc., to include additional territories in Asia for the development and commercialization of HLX78 (oral lasofoxifene). This supplementary agreement facilitates a co-development partnership between Henlius and…
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Healthcare Firms Line Up for HKEX IPOs as Biotech Market Recovery Gains Momentum
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A number of healthcare companies are seeking to capitalize on the recovering market conditions by filing for initial public offerings (IPOs) on the Hong Kong Stock Exchange (HKEX), a venue that has been gaining traction among life sciences companies for their public listings. According to the HKEX website, recent IPO…
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Hinova Pharmaceuticals’ HP518 Earns FDA Fast-Track Designation for AR+ Triple Negative Breast Cancer
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Hinova Pharmaceuticals (SHA: 688302), a biopharmaceutical company based in China, has announced that it has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its drug candidate HP518 for the treatment of androgen receptor (AR)-positive triple negative breast cancer (TNBC). The Category 1 innovative drug candidate, HP518,…
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Gloria Bio’s Motixafortide Approved as Urgently Needed Import Drug by Hainan Medical Products Administration
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Guangzhou Gloria Biosciences Co., Ltd, a biopharmaceutical company based in China, has received approval from the Hainan Medical Products Administration for its CXCR4 antagonist motixafortide (BL-8040) as a special drug for import due to clinical urgency. The drug will be implemented and administered by Hainan Boao Lu Medical Hospital, a…
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BeiGene’s Tislelizumab Approved by China’s NMPA for First-Line Extensive Stage Small Cell Lung Cancer
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a biopharmaceutical company, has announced that its programmed-death (PD)-1 monoclonal antibody (mAb), tislelizumab, has received approval from the National Medical Products Administration (NMPA) in China. The drug is now approved to be used in combination with chemotherapy for the treatment of patients with…
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Grand Pharmaceutical Group Ltd’s SIR-Spheres Set to Reach Wider Patient Base Through MediTrust Health Deal
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Grand Pharmaceutical Group Ltd (HKG: 0512), a leading pharmaceutical company based in China, has announced a strategic partnership with MediTrust Health, an insurance, financing, and direct-to-patient pharmacy subsidiary of Shanghai Pharmaceuticals Holding Co., Ltd. This collaboration will focus on integrating Grand Pharma’s 90Y product into various commercial insurance schemes, aiming…
