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Eli Lilly Launches Three New Oncology Programs Targeting KRAS and Nectin-4
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Eli Lilly (NYSE: LLY) has announced the initiation of three innovative oncology programs focusing on KRAS and Nectin-4, all of which are currently in the pre-clinical stage. This strategic move highlights Lilly’s commitment to advancing cancer therapies that target specific oncogenic pathways. Details of the New Oncology Programs The new…
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FDA Rejects Eli Lilly’s Application for Lebrikizumab in Atopic Dermatitis Treatment
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The U.S. Food and Drug Administration (FDA) has rejected Eli Lilly’s (NYSE: LLY) application for lebrikizumab, an anti-IL-13 biologic intended for the treatment of moderate-to-severe atopic dermatitis. The company announced the setback this week, highlighting the challenges faced in the regulatory approval process. Background on Lebrikizumab’s Acquisition Eli Lilly acquired…
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Innovent Biologics Doses First Patient in Phase 3 Study of IBI302 for Neovascular AMD
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced that the first patient with neovascular age-related macular degeneration (nAMD) has been successfully dosed in the Phase 3 clinical study (STAR) of efdamrofusp alfa (IBI302). This recombinant fully human anti-VEGF and anti-complement bispecific fusion protein aims to address unmet needs in nAMD…
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HutchMed and Takeda Submit Fruquintinib NDA for Metastatic CRC in Japan
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China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced that its partner Takeda (TYO: 4502) has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for the approval of fruquintinib as a treatment for adult patients with previously treated metastatic colorectal cancer (CRC).…
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Bio-Thera Solutions’ BAT1806 Receives US FDA Approval as Biosimilar to Actemra/RoActemra
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Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, announced that its biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab), known as BAT1806, has passed review by the US FDA. This milestone marks the approval of BAT1806 for use in the US market to treat a range of…
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Sichuan Biokin’s IZalontamab Gets US FDA Greenlight for NSCLC Clinical Study
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its innovative biologic drug, izalontamab (SI-B001). The trial will focus on assessing the efficacy of izalontamab in combination…
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Innovent Biologics Withdraws Parsaclisib Filing in China, Halts Development
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Innovent Biologics Inc., a leading China-based biotech company (HKG: 1801), has announced the voluntary withdrawal of its market approval filing for the drug candidate parsaclisib in China. Furthermore, the company has decided to halt all further development of the molecule, as stated in their press release. Background on Parsaclisib and…
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Jiangsu Hengrui Licenses Pyrotinib to Dr. Reddy’s for Indian Market
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has entered into a licensing agreement with India-headquartered Dr. Reddy’s Laboratories, granting the latter exclusive development and commercialization rights for its HER1/HER2/HER4 inhibitor, pyrotinib, in India. Financial Terms of the Agreement Under the terms of the agreement, Hengrui will receive an upfront…
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AstraZeneca Reports Positive Phase III Results for Forxiga in Children with Type 2 Diabetes
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UK-based AstraZeneca (AZ, NASDAQ: AZN) has announced promising results from the Phase III T2NOW study (NCT03199053) for its diabetes medication, Forxiga (dapagliflozin), in adolescents and children aged 10 to 17 with type 2 diabetes (T2D). Enrolling 256 patients, this study stands as one of the largest investigations into type 2…
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Sanofi’s Nexviazyme Approved in China as Enzyme Replacement Therapy for Pompe Disease
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Sanofi’s (NASDAQ: SNY) next-generation enzyme replacement therapy (ERT), Nexviazyme (avalglucosidase alfa), has received marketing approval from the National Medical Products Administration (NMPA) as a long-term treatment for Pompe disease. This marks Sanofi’s second drug approved for Pompe disease in China, following the approval of Myozyme (alglucosidase alfa) in October 2015.…
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Takeda Initiates Global Withdrawal of Exkivity Following Phase III Trial Results
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Japan-based Takeda (TYO: 4502) has announced the voluntary global withdrawal of its tyrosine kinase inhibitor (TKI) Exkivity (mobocertinib) from the U.S. market. This decision comes after a Phase III confirmatory trial failed to meet its primary efficacy endpoint. Exkivity, a first-in-class therapy, had previously received conditional approvals worldwide as a…
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Everest Medicines and Calliditas Present New Data on Nefecon for IgA Nephropathy
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Everest Medicines (HKG: 1952), in partnership with Calliditas Therapeutics AB (Nasdaq: CALT), recently presented new biomarker and subgroup analyses for Nefecon, a targeted oral formulation of budesonide currently under clinical development for the treatment of IgA nephropathy (IgAN). The data was showcased during both poster and oral presentations at the…
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Zhaoke Ophthalmology Completes Patient Enrollment for Phase III Trials of TAB014 and Epinastine
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Zhaoke Ophthalmology Ltd (HKG: 6622), a former subsidiary of Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), has announced the successful completion of patient enrollment for two separate Phase III clinical studies: one for TAB014 and another for epinastine, a generic version of Allergan’s Elestat. This milestone underscores Zhaoke’s commitment to advancing…
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Amicus Therapeutics Secures FDA Approval for Pombiliti and Opfolda Combination Therapy
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Amicus Therapeutics (NASDAQ: FOLD), headquartered in the United States, has announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for its combination therapy of Pombiliti (cipaglucosidase alfa-atga) and Opfolda (miglustat) 65 mg capsules. This innovative two-component therapy is specifically indicated for adults diagnosed with…
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Transcenta Secures FDA Approval for Phase III Trial of Osemitamab
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China-based Transcenta Holding Ltd (HKG: 6628) has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate the global Phase III pivotal TranStar study for its pipeline candidate, osemitamab (TST001). This clinical trial will evaluate the efficacy of osemitamab in combination with nivolumab and…
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Takeda Receives FDA Approval for Subcutaneous Entyvio as UC Maintenance Therapy
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The US Food and Drug Administration (FDA) has granted Japan’s Takeda Pharmaceuticals (TYO: 4502) regulatory approval for the subcutaneous version of its alpha4beta7 integrin inhibitor, Entyvio (vedolizumab), as a maintenance therapy for adults with moderately to severely active ulcerative colitis (UC) following induction therapy with intravenous Entyvio. This decision comes…
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Eli Lilly’s Insulin Biosimilar YouBiAn Approved for Diabetes Treatment in China
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US pharmaceutical major Eli Lilly (NYSE: LLY) has announced that it has received market approval from the National Medical Products Administration in China for its insulin glargine product, YouBiAn. This treatment is indicated for adults with type 1 or type 2 diabetes requiring insulin therapy, as well as for children…
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Everest Medicines’ Xerava Receives Marketing Approval from TFDA for cIAI Treatment
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Everest Medicines (HKG: 1952) has announced that it has received marketing approval for its antibiotic Xerava (eravacycline) from the Taiwan Food and Drug Administration (TFDA). This approval grants the drug permission to be used in the treatment of complicated intra-abdominal infections (cIAI) in Taiwan, expanding the drug’s reach in the…
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Konruns Pharmaceutical’s KC1036 Pediatric Indication Accepted for NMPA Review
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for its Category 1 chemical drug, KC1036, for a pediatric indication. This development signifies a significant step forward in the exploration of new treatment options for pediatric cancer…
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Elpiscience Biopharmaceuticals Initiates Phase I Trial for Anti-LILRB2 Antibody ES009
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Elpiscience Biopharmaceuticals, a China-based biopharmaceutical company, has announced that the first patient has been dosed in a Phase I clinical trial in Australia for its pipeline candidate, ES009. This investigational drug is an anti-LILRB2 (ILT4) monoclonal antibody developed to target cancers, marking a significant step in the company’s oncology research…
