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UK MHRA Approves Eisai and Biogen’s Alzheimer’s Drug Leqembi, Despite NICE Reimbursement Rejection
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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for Leqembi (lecanemab), a co-developed Alzheimer’s disease drug by Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB). This development, however, was met with a refusal from the National Institute for Health and Clinical Excellence (NICE), the…
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Everest Medicines Launches Trial for Personalized mRNA Cancer Vaccine EVM16 in Solid Tumors
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Everest Medicines, a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 1952), has announced the commencement of an investigator-initiated trial (ITT) for its cutting-edge personalized mRNA cancer vaccine, EVM16. The trial, spearheaded by Beijing Cancer Hospital and Fudan University Shanghai Cancer Center, is a…
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Regeneron’s Linvoseltamab Faces FDA Complete Response Letter, Awaiting Reinspection of Manufacturer
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Regeneron Pharmaceuticals Inc., a leading biopharmaceutical company based in the US and listed on the Nasdaq (NASDAQ: REGN), has encountered a setback in its pursuit of market approval for the bispecific antibody (BsAb) linvoseltamab. The US FDA has issued a Complete Response Letter (CRL) regarding the company’s filing for this…
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CK Life Sciences’ Halneuron Receives FDA Fast-Track Designation for Chemotherapy-Induced Neuropathic Pain
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CK Life Sciences (HKG: 0775), a biopharmaceutical company headquartered in China, has received fast-track designation from the US Food and Drug Administration (FDA) for its drug candidate Halneuron, which contains tetrodotoxin, for the treatment of chemotherapy-induced neuropathic pain (CINP). Halneuron is an innovative injectable form of tetrodotoxin, a naturally occurring…
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Innovent Biologics’ Fulzerasib Receives NMPA Approval for Advanced NSCLC Treatment in China
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Innovent Biologics Inc., a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 1801), has announced that it has obtained marketing approval from China’s National Medical Products Administration (NMPA) for its drug fulzerasib. This approval grants the company the green light to market fulzerasib, under…
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Qilu Pharmaceutical’s Biosimilar Ranibizumab Receives NMPA Approval, Marking a First in China
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Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its biosimilar version of Novartis’s blockbuster drug Lucentis (ranibizumab) has received market approval from the National Medical Products Administration (NMPA). This regulatory nod positions the product as the first biosimilar of its kind to be approved in China. Ranibizumab, a vascular…
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BrightGene Bio Receives FDA Clearance for Generic Eribulin APIs, Advancing in Breast Cancer Treatment
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BrightGene Bio-Medical Technology Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange (SHA: 688166), has announced the receipt of a First Adequate Letter from the US FDA for the active pharmaceutical ingredients (APIs) of its generic version of Eisai’s Halaven (eribulin), signifying that the drug has successfully…
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Daiichi Sankyo Launches Tarlige for Diabetes Peripheral Neuropathic Pain in China
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Daiichi Sankyo (TYO: 4568), a leading Japanese pharmaceutical company, has announced the official market launch of its medication Tarlige (mirogabalin) in China, targeting the treatment of diabetes peripheral neuropathic pain (DPNP). This third-generation calcium channel regulator received marketing approval in China in July of this year and holds the potential…
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Akeso Biopharma’s Ivonescimab Earns Category 1 Recommendation in China’s 2024 Lung Cancer Clinical Guideline
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Akeso Biopharma, a China-based pharmaceutical company listed on the Hong Kong Stock Exchange (HKG: 9926), has achieved a significant milestone with its bispecific antibody ivonescimab (AK112). This innovative drug, which targets both programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), has been included in the “Clinical Practice Guideline for…
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Hangzhou Biosunpharma’s OB756 New Drug Application Accepted for Myelofibrosis Treatment by China’s NMPA
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Hangzhou Biosunpharma Co., Ltd. has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its investigational compound OB756. The company is seeking regulatory approval for the treatment of patients with medium to high-risk myelofibrosis (MF). OB756 is a novel JAK2 inhibitor…
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Jiangsu Hansoh and GSK Receive FDA Breakthrough Designation for B7-H3 Targeted ADC in Small-Cell Lung Cancer
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Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), a prominent Chinese pharmaceutical company, and its UK counterpart GSK plc (NYSE: GSK) have jointly announced that they have received the prestigious Breakthrough Therapy Designation (BTD) from the US FDA for their candidate HS-20093, also known as GSK5764227. This B7-H3-targeted antibody-drug conjugate (ADC)…
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J&J’s Rybrevant-Lazclude Combo Approved by FDA, Challenging AstraZeneca’s Tagrisso in NSCLC Treatment
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Johnson & Johnson (J&J; NYSE: JNJ) has secured a new market approval in the United States for the combined use of its bispecific antibody Rybrevant (amivantamab) and the tyrosine kinase inhibitor (TKI) Lazclude (lazertinib). Following a priority review, the US FDA approved this dual therapy for the first-line treatment of…
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AstraZeneca’s Strensiq Approved for Rare Disease Therapy under Greater Bay Area’s Drug Access Policy
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AstraZeneca (NASDAQ: AZN, LON: AZN) , a leading UK pharmaceutical company, has received approval for its rare disease therapy Strensiq (asfotase alfa) from the Guangdong Medical Products Administration (MPA) bureau. This clearance allows Strensiq to be introduced to medical institutions under the “Hong Kong-Macau Drug and Device Access” policy, a…
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Jiangsu Hansoh Pharmaceutical and GSK Win FDA Breakthrough Therapy Designation for B7-H3 Targeted ADC in Small-Cell Lung Cancer
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LONDON/HONG KONG—Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), in collaboration with UK-based GSK plc (NYSE: GSK), has been awarded the Breakthrough Therapy Designation (BTD) by the US FDA for their jointly developed antibody-drug conjugate (ADC) HS-20093, also known as GSK5764227. The therapy is intended for the treatment of patients with…
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Johnson & Johnson’s Rybrevant-Lazclude Combo Approved by FDA for First-Line NSCLC Treatment
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NEW YORK—Healthcare conglomerate Johnson & Johnson (J&J; NYSE: JNJ) has secured a significant regulatory milestone with the US FDA’s approval of its bispecific antibody Rybrevant (amivantamab) in combination with the tyrosine kinase inhibitor (TKI) Lazclude (lazertinib). The priority review has led to a green light for the combined use of…
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AstraZeneca’s Strensiq Gains Approval for Rare Disease Therapy in Guangdong Under “Hong Kong-Macau Drug and Device Access”
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LONDON—AstraZeneca (NASDAQ: AZN, LON: AZN) , a leading UK-based pharmaceutical company, has announced that its rare disease therapy Strensiq (asfotase alfa) has been granted market access by the Guangdong Medical Products Administration (MPA) bureau. This approval is a significant step under the “Hong Kong-Macau Drug and Device Access” policy, which…
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Hasten Biopharmaceutical Gains NMPA Nod for Somatostatin Marketing Rights in China
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BEIJING—Hasten Biopharmaceutical Co., Ltd, a biopharmaceutical company supported by the CBC Group, has received approval from the National Medical Products Administration (NMPA) to transfer the Marketing Authorization Holder (MAH) for its product Stilamin (somatostatin) in mainland China. The natural peptide hormone, somatostatin, is utilized in the treatment of acute bleeding…
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Yipinhong Pharmacy’s AR882 Earns FDA Fast-Track Status for Gout Treatment
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BEIJING—China-based Yipinhong Pharmacy Co., Ltd (SHE: 300723) has announced that its novel drug AR882 has received fast-track designation from the US Food and Drug Administration (FDA) for the treatment of visible tophi in patients with gout. This Category 1 drug, co-developed with US firm Arthrosi Therapeutics Inc., is a next-generation…
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Astellas Pharma’s Padcev Receives NMPA Approval for Urothelial Cancer Treatment
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TOKYO—Astellas Pharma Inc. (TYO: 4503) has announced that its anti-HER3 antibody-drug conjugate (ADC), Padcev (enfortumab vedotin), in partnership with Pfizer, has been granted approval by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) who have received prior platinum-containing…
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BioNTech’s BNT326/YL202 Clears FDA Hurdle, Advancing in Clinical Trials for Solid Tumor Treatment
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FRANKFURT—BioNTech SE (NASDAQ: BNTX), a leading German biotechnology company, has announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold on its Phase I clinical trial for BNT326/YL202, an anti-HER3 targeted antibody drug conjugate (ADC). This development paves the way for the resumption of trials…
