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Huadong Medicine’s Arcalyst Receives NMPA Approval for Recurrent Pericarditis Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Arcalyst (rilonacept), a treatment for recurrent pericarditis (RP). This marks an expansion of the drug’s application in addressing autoimmune diseases. Rilonacept’s Mechanism and Global ApprovalsRilonacept is a recombinant…
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IMEIK Technology Receives NMPA Approval for Recombinant Human Hyaluronidase Clinical Study
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China-based IMEIK Technology Development Co., Ltd (SHE: 300896) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its recombinant human hyaluronidase for injection. The study aims to explore the use of the drug to promote the diffusion of subcutaneous infusion as an…
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Patronus Biotech’s RSV Vaccine LYB005 Receives NMPA Approval for Clinical Study
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Guangzhou Patronus Biotech Co., Ltd., a vaccine start-up specializing in respiratory and infectious diseases, has received approval from China’s National Medical Products Administration (NMPA) to initiate a clinical study for its recombinant respiratory syncytial virus (RSV) vaccine (CHO cells), LYB005. LYB005’s U-VLP Technology and Clinical ProgressLYB005 is an RSV vaccine…
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Shanghai Pharmaceuticals’ SRD4610 Receives FDA Orphan Drug Designation for ALS Treatment
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China’s Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607) has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its SRD4610, an in-house developed compound Chinese medicine, for the treatment of amyotrophic lateral sclerosis (ALS). This designation highlights the potential impact of SRD4610 in…
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Sperogenix Therapeutics’ Agamree Receives NMPA Approval for Duchenne Muscular Dystrophy Treatment
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China-based rare disease specialist Sperogenix Therapeutics Limited has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its drug Agamree (vamorolone), which is used to treat patients with Duchenne muscular dystrophy (DMD). This marks a significant milestone as Agamree becomes the first DMD drug approved in China,…
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Jiangsu Hengrui Pharmaceuticals Secures NMPA Approvals for SHR-4394 and HRS-3802 Clinical Trials
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving separate clinical trial approvals from China’s National Medical Products Administration (NMPA) for its two drug candidates, SHR-4394 and HRS-3802. SHR-4394: A Novel Therapeutic Biologic for Prostate CancerSHR-4394 is an in-house developed therapeutic biologic product, with its target undisclosed, currently under…
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Merck’s PD-1 Inhibitor Keytruda Approved by NMPA for Cervical Cancer Treatment in China
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US-based Merck, Sharp & Dohme Inc., (MSD, NYSE: MRK) has announced receiving marketing approval from China’s National Medical Products Administration (NMPA) for its PD-1 inhibitor Keytruda (pembrolizumab). The approval allows the use of Keytruda in combination with chemotherapy for International Federation of Obstetrics and Gynecology (FIGO) 2014 stage III-IVA cervical…
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MSD’s Noxafil Receives NMPA Approval for Pediatric Use in Antifungal Treatment
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US-based Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced that China’s National Medical Products Administration (NMPA) has approved an extended indication for its antifungal agent Noxafil (posaconazole) to include pediatric patients in the prevention and treatment of fungal infections. This approval covers two dosage forms: enteric-coated tablets and…
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NMPA Approves Zynlonta for Relapsed or Refractory Large B-Cell Lymphoma Treatment
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The website of China’s National Medical Products Administration (NMPA) has indicated that the marketing filing for Zynlonta (loncastuximab tesirine), a collaboration between China’s Overland Pharmaceuticals and Swiss firm ADC Therapeutics SA (NYSE: ADCT), has been approved. This approval allows the CD19-targeted antibody-drug conjugate (ADC) to be used for treating adult…
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Wuhan YZY Biopharma’s M701 Shows Promise in Phase II Study for Malignant Pleural Effusion at ESMO ASIA 2024
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China-based Wuhan YZY Biopharma Co., Ltd (HKG: 2496) has announced the presentation of results from a Phase II clinical study for its M701, a recombinant anti-EpCAM and CD3 human murine chimeric bispecific antibody (BsAb) injection, at the ESMO ASIA Congress 2024. The study focused on patients with malignant pleural effusion…
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Porton Pharma Solutions and OD Kingsley Life Sciences Form Partnership for Bio Conjugated Drug Development
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China-based Contract Development and Manufacturing Organization (CDMO) Porton Pharma Solutions (SHE: 300363) has announced a strategic partnership with OD Kingsley Life Sciences (Yixing) Co., Ltd, a joint venture between Kingsley Pharmaceutical and Hong Kong-headquartered OD Therapeutics Limited. The partnership aims to leverage Porton’s expertise in Chemistry, Manufacturing, and Controls (CMC)…
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Stereotaxis and MicroPort EP Receive NMPA Approval for Magbot Magnetic Navigation Ablation Catheter
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US-based Stereotaxis, Inc. (NYSEAMERICAN: STXS) and its Chinese partner Shanghai MicroPort EP Medtech Co., Ltd. (SHA: 688351, MicroPort EP) have jointly announced the receipt of marketing approval from the National Medical Products Administration (NMPA) of China for their co-developed Magbot magnetic navigation ablation catheter. This approval marks a significant milestone…
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Immunofoco’s IMC002 Earns FDA Fast-Track Designation for CLDN 18.2-Positive Gastric Cancer
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Immunofoco, a leading developer in tumor immunotherapy based in Suzhou, has announced that it has received Fast-Track Designation (FTD) from the US Food and Drug Administration (FDA) for its IMC002. This chimeric antigen receptor (CAR)-T therapy targets CLDN 18.2 and is intended for the treatment of patients with unresectable locally…
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InnoVec Biotherapeutics’ IVB102 Receives FDA IND Approval for X-Linked Retinoschisis Treatment
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Beijing-based gene therapy specialist InnoVec Biotherapeutics Inc. has announced receiving Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its IVB102. This development follows the completion of enrollment in the investigator-initiated trial (ITT) at Peking Union Medical College Hospital. The FDA clearance was granted based…
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Nona Biosciences Partners with Kodiak Sciences to Discover Multi-Target Ophthalmic Antibodies
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Nona Biosciences, a wholly-owned subsidiary of HBM Holdings Ltd (HKG: 2142), has joined forces with US-based Kodiak Sciences lnc. (NASDAQ: KOD) in a strategic partnership aimed at advancing the discovery of novel multi-target antibodies to treat ophthalmic diseases. The collaboration will leverage Nona Bio’s proprietary Harbour Mice fully human antibody…
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Eisai’s Urece (Dotinurad) Approved by China’s NMPA for Gout Treatment with Hyperuricemia
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Eisai’s (TYO: 4523) China unit has announced that it has received marketing approval from the National Medical Products Administration (NMPA) of China for its Urece (dotinurad), a uric acid excretion promoting drug. This approval allows the use of Urece to treat gout patients with hyperuricemia in China. Phase III Study…
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Daiichi Sankyo and AstraZeneca’s Datopotamab Deruxtecan Earns FDA Breakthrough Therapy Designation
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Partners Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) have jointly announced that their co-developed TROP-2-targeted antibody drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd), has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA). The designation is based on the positive results from the Phase II…
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Shanghai Pharmaceuticals and Sichuan Kelun-Biotech Partner to Expand Sacituzumab Tirumotecan Market Access
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Shanghai Pharmaceuticals (SHA: 601607; SPH) has entered into a strategic partnership with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990). The collaboration aims to leverage the advantageous resources of both companies to deepen market access, explore innovative financial payments, and other services for sacituzumab tirumotecan, a TROP2-targeted antibody drug conjugate (ADC)…
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China Medical System’s Methylthioninium Tablets Receive First Prescriptions for Colonoscopy Use
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China Medical System Holdings (CMS; HKG: 0867) has announced that the first prescriptions have been issued in China for its methylthioninium enteric coated sustained-release tablets. These tablets are designed to enhance the visualization of colorectal lesions in adult patients undergoing colonoscopy screening or monitoring. Methylthioninium’s Multi-Matrix Technology and MechanismMethylthioninium utilizes…
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Dizal Pharmaceutical Unveils Promising Data on DZD8586 for B-NHL at ASH Annual Meeting
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has presented new data from a pooled safety and efficacy analysis of DZD8586, a non-covalent blood-brain barrier (BBB) penetrant dual inhibitor targeting LYN and BTK, in patients with B-cell non-Hodgkin lymphoma (B-NHL) at the 66th American Society of Hematology (ASH) Annual Meeting. Clinical…
