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Jiangsu Simcere Pharmaceutical Gets NMPA Green Light for SIM0508 Clinical Trial in Advanced Solid Tumors
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Jiangsu Simcere Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed in Hong Kong (HKG: 2096), has announced that it has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for its pipeline candidate SIM0508. This molecule is a DNA polymerase theta (Pol theta) small molecule inhibitor, which is…
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Mabwell Bioscience Receives Approval for Phase III Trial of 9MW2821 in Cervical Cancer from China’s CDE
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Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has received approval from the Center for Drug Evaluation (CDE) in China to proceed with a Phase III clinical trial for its pipeline candidate, 9MW2821. The study is designed as a randomized, open, controlled, multi-center trial, comparing…
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Gene Cradle Initiates First Regulatory Gene Therapy Study in China for Late-Onset Pompe Disease
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Gene Cradle, a Beijing-based gene therapy specialist, has achieved a milestone by administering its GC301 to the first patient with late-onset Pompe disease (LOPD) in a regulatory study in China. This marks the nation’s first patient dosing of an adeno-associated virus (AAV) gene therapy for LOPD. GC301 is an innovative…
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Phase I Success for Shandong Xinhua’s OAB-14, Advancing to Phase IIa in Alzheimer’s Therapy
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Shandong Xinhua Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed in Shenzhen (SHE: 000756), has declared the successful completion of a Phase I clinical trial for its OAB-14 drug candidate in a dry suspension formulation. Following the positive outcome, the company is now gearing up to initiate a Phase IIa…
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Hunan Warrant Pharmaceutical’s ZG-002 Receives NMPA Approval for Clinical Trials in Plaque Psoriasis
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Hunan Warrant Pharmaceutical Co., Ltd, a pharmaceutical company based in China and listed on the Shanghai Stock Exchange’s Science and Technology Innovation Board (SHA: 688799), has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug candidate, ZG-002. This new molecule is intended for…
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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…
