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AbbVie’s Elahere Receives EC Approval for FRα-Positive Ovarian Cancer Treatment
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US-based AbbVie (NYSE: ABBV) has announced the European Commission (EC) approval for its antibody drug conjugate (ADC) Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. This approval marks Elahere as the first and…
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Huadong Medicine’s DR10624 Receives NMPA Approval for MAFLD and MASH Clinical Trials
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with clinical trials for its protein drug DR10624 in metabolic related fatty liver disease (MAFLD) and metabolic associated steatohepatitis (MASH). DR10624’s Mechanism and Pre-Clinical PerformanceDR10624 is a…
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Huadong Medicine’s HDM1005 Receives FDA Approval for MASH Clinical Study
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Huadong Medicine Co., Ltd (SHE: 000963), 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 Category 1 chemical drug, HDM1005, in metabolic associated steatohepatitis (MASH). This development marks a significant step forward for…
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Huadong Medicine’s Biosimilar SaiLeXin Receives First National Prescription in China
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China-based pharmaceutical company Huadong Medicine Co., Ltd (SHE: 000963) has announced a significant milestone with the issuance of the first national prescription for its biosimilar drug, SaiLeXin, at the Peking University People’s Hospital. This marks a new chapter in the treatment of autoimmune diseases in China, offering patients an alternative…
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Huadong Medicine Co., Ltd Receives NMPA Approval for Stelara Biosimilar SaiLeXin
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Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) auto-immune disease drug Stelara (ustekinumab), named SaiLeXin. This development marks a significant step forward…
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Huadong Medicine Gets Green Light for HPK1 PROTAC Drug HDM2006 in Advanced Solid Tumors
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a study for its Category 1 chemical drug HDM2006, which targets advanced solid tumors. This development marks a significant step for Huadong as it…
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Huadong Medicine Secures NMPA Approval for Semaglutide Biosimilar, Aims to Capture Weight Loss Market
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Nanjing-based Huadong Medicine Co., Ltd (SHE: 000963) has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its biosimilar version of Novo Nordisk’s (NYSE: NVO) weight loss drug semaglutide, which is marketed under the names Ozempic and Wegovy. Huadong Medicine’s biosimilar will be evaluated for weight management…
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Huadong Medicine Gets NMPA Green Light for Clinical Trials of Roflumilast Cream
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced that it has received clinical trial approvals from the National Medical Products Administration (NMPA) for its Zoryve cream (roflumilast) in concentrations of 0.15% and 0.3%. These formulations are indicated for the treatment of mild to moderate atopic dermatitis…
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Huadong Medicine’s V20 Device Receives NMPA Approval for Market Launch
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category III medical device, V20. The V20 is an intense pulsed light radiofrequency therapy device designed for various dermatological treatments. The V20 therapeutic…
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Huadong Medicine Secures Exclusive Rights to Janagliflozin for Type 2 Diabetes Treatment in China
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has entered into a licensing agreement with fellow Chinese firm Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460), securing exclusive commercialization rights for Sihuan’s Category 1 drug, janagliflozin, in mainland China. Under the terms of the agreement, Huadong will handle the…
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Huadong Medicine Secures Licensing Deal with IMBiologics for Autoimmune Drug Candidates
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Huadong Medicine Co., Ltd. (SHE: 000963), a Chinese pharmaceutical company, has entered into a licensing agreement with South Korea’s IMBiologics, securing development, regulatory filing, manufacturing, and commercialization rights for the autoimmune drug candidates IMB-101 and IMB-102. This agreement spans China and 36 additional Asian countries, excluding Japan, South Korea, and…
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Huadong Medicine Expands Global Footprint with Launch of Aesthetic Injection MaiLi in Singapore
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced the international expansion of its medical aesthetics portfolio with the launch of its high-end aesthetic injection product, MaiLi, in Singapore. This marks another milestone in the company’s global foray into the medical aesthetics sector. MaiLi is a premium…
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Huadong Medicine Secures Exclusive Rights to Immunochina’s CAR-T Therapy in China
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China-based pharmaceutical company Huadong Medicine Co., Ltd (SHE: 000963) has entered into a licensing agreement with Beijing-based gene therapy specialist Immunochina Pharmaceuticals. The agreement grants Huadong exclusive commercialization rights to Immunochina’s IM19, a promising CD19-targeted autologous chimeric antigen receptor (CAR) T cell therapy, within mainland China. Huadong will make an…
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Jiangsu QYuns Therapeutics and Huadong Medicine Partner on QX005N Injection Development and Promotion
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Jiangsu QYuns Therapeutics Co., Ltd (HKG: 2509), a biopharmaceutical company based in China, has entered into a co-development and market promotion service agreement with Huadong Medicine Co., Ltd (SHE: 000963) for the development and commercialization of QX005N injection. Under the terms of the agreement, Huadong will participate in the clinical…
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Huadong Medicine to Expand TCM Footprint with Acquisition of Hengba Pharmaceutical
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced its intention to acquire a 100% stake in Guizhou Hengba Pharmaceutical Co., Ltd, a traditional Chinese medicine (TCM) firm, for a total consideration of RMB 528.47 million (USD 72.66 million). Established in 1995, Hengba Pharmaceutical has a robust…
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Huadong Medicine’s Partner Arcutis Gets FDA Nod for Roflumilast Cream
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, announced that its co-development partner Arcutis Biotherapeutics Inc., (NASDAQ: ARQT), has received approval from the U.S. Food and Drug Administration (FDA) for a supplementary New Drug Application (sNDA) for Zoryve cream (roflumilast). This clearance is for treating mild to moderate…
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Huadong Medicine Secures Exclusive Rights to Oral Edaravone Candidate TTYP01 in Major Licensing Deal
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Huadong Medicine Co., Ltd (SHE: 000963), a prominent pharmaceutical company in China, has entered into an exclusive licensing agreement with Suzhou Auzone Biological Technology Co., Ltd, focusing on Auzone’s product candidate TTYP01, an oral formulation of edaravone. This strategic partnership positions Huadong to exclusively develop, regulate, manufacture, and commercialize the…
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Huadong Medicine’s ROR1-Targeting ADC HDM2005 Receives FDA Clinical Trial Approval
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Huadong Medicine Co., Ltd (SHE: 000963), a pharmaceutical company based in China, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC), HDM2005. This molecule targets recombinant receptor tyrosine kinase-like orphan receptor 1 (ROR1) and is intended…
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Huadong Medicine’s ROR1-Targeting ADC HDM2005 Cleared for Clinical Trials by China’s NMPA
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Huadong Medicine Co., Ltd (SHE: 000963), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with clinical trials for HDM2005, an antibody-drug conjugate (ADC) that targets the recombinant receptor tyrosine kinase-like orphan receptor 1 (ROR1). The molecule…
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3SBio Secures License for Semaglutide Biosimilar from Hybio Pharmaceutical
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3SBio Inc. (HKG: 1530), a biopharmaceutical company based in China, has announced a licensing agreement with fellow Chinese firm Hybio Pharmaceutical Co., Ltd (SHE: 300199) for the development of a semaglutide biosimilar. Under this agreement, 3SBio will gain access to Hybio’s preclinical technical results for the drug and will be…
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Huadong Medicine’s EGFR Inhibitor Mefatinib for NSCLC Accepted by NMPA for Review
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Huadong Medicine Co., Ltd (SHE: 000963), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its filing for market approval of mefatinib. The drug is proposed as a first-line treatment for locally advanced or metastatic non-small cell lung cancer…
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Huadong Medicine’s Lidocaine-Containing Hyaluronic Acid Gel Accepted for NMPA Review
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted for review the market approval filing for its Category III medical device, MaiLi Extreme, a lidocaine-containing crosslinked sodium hyaluronate gel. This high-end hyaluronic acid product, which received the CE mark in June…
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Huadong Medicine’s HDM1005 Receives US FDA Clinical Trial Approval for Weight Management
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its investigational drug HDM1005. This long-acting agonist targets the GLP-1 receptor and GIP receptor and is under development for weight management in overweight or obese…
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Huadong Medicine Gets NMPA Approval for Clinical Trial of FRα-Targeting ADC Elahere
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for Elahere (mirvetuximab soravtansine), the company’s antibody drug conjugate (ADC) that targets folate receptor α (FRα). The study will evaluate Elahere as a…
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CNIPA Invalidates Novo Nordisk’s Victoza Patent, Opening Door for Chinese Biosimilars
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The China National Intellectual Property Administration (CNIPA) has declared invalid the patent No. 201510572124.1 held by Denmark-based Novo Nordisk (NYSE: NVO) related to Victoza (liraglutide) and its stable preparation of proinsulin peptide. This patent was challenged by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a subsidiary of China’s Huadong Medicine Co.,…
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Huadong Medicine Secures NMPA Approval for HDM1005, Targeting Type 2 Diabetes and Obesity
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Huadong Medicine Co., Ltd (SHE: 000963), based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HDM1005. This long-acting agonist targets both the GLP-1 and GIP receptors and is being developed for the treatment of type 2…
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Huadong Medicine’s Arcalyst Filing for Recurrent Pericarditis Accepted by China’s NMPA
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Huadong Medicine Co., Ltd, (SHE: 000963) a Chinese pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted for review its market approval filing for the injectable Arcalyst (rionacept). The drug is indicated for the treatment of recurrent pericarditis (RP) in adults and adolescents aged…
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Huadong Medicine’s MaiLi Extreme Achieves Clinical Study Milestone for Chin Retraction Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that a Chinese clinical study for MaiLi Extreme, an injectable lidocaine-containing sodium hyaluronate by its UK subsidiary Sinclair, has successfully met its primary endpoint, demonstrating good safety data. The study aimed to evaluate the efficacy and safety of MaiLi Extreme injections…
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CARsgen Therapeutics’ BCMA-targeted CAR-T Cell Therapy Approved by China’s NMPA
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CARsgen Therapeutics Holdings Ltd (HKG: 2171), a specialist in chimeric antigen receptor (CAR)-T cell therapies based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its product CT053 (zevorcabtagene autoleucel; zevor-cel). This B-cell maturation antigen (BCMA)-targeted CAR-T cell therapy is now…
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Huadong Medicine’s Relmapirazin Approval Filing Accepted by NMPA for GFR Measurement
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Huadong Medicine Co., Ltd (SHE: 000963), based in China, has announced that its market approval filing for relmapirazin, a Category 1 chemical drug and fluorescent tracer for measuring glomerular filtration rate (GFR), has been accepted for review by the National Medical Products Administration (NMPA). This tracer is designed for use…
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Huadong Medicine Ends Collaboration on vTv’s TTP273 for Diabetes Treatment
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US-based vTv Therapeutics LLC has received a cancellation notice from China’s Huadong Medicine Co., Ltd., (SHE: 000963) regarding their joint development of the type 2 diabetes drug TTP273. Huadong, confirming the cancellation, stated that TTP273 was found to be inferior to its own drug candidate, HDM1002. TTP273, a first-in-class, non-peptide,…
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Huadong Medicine Cancels Collaboration with vTv Therapeutics on TTP273 for Type 2 Diabetes Drug
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vTv Therapeutics LLC, a US-based pharmaceutical company, has announced receiving a cancellation notification from China-based Huadong Medicine Co., Ltd (SHE: 000963) regarding their collaboration on the type 2 diabetes drug TTP273. Huadong confirmed the news, stating that TTP273 was considered inferior to its in-house developed drug HDM1002. TTP273, a first-in-class…
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Huadong Medicine Strikes Exclusive Promotion Deal with Impact Therapeutics for Senaparib in China
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has entered into an exclusive market promotion service agreement with domestic firm Impact Therapeutics, securing exclusive market promotion rights for Impact’s senaparib in mainland China. Under the agreement, Huadong will pay an initial fee of RMB 100 million (USD 14 million) and is…
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Huadong Medicine Gets NMPA Green Light for Clinical Study of Ryzodeg Biosimilar
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its biosimilar version of Novo Nordisk’s (NYSE: NVO) Ryzodeg (insulin degludec, insulin aspart), intended for the treatment of adults with type 2 diabetes.…
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Huadong Medicine Gets NMPA Green Light for Sirolimus Real-World Study in Pediatric Epilepsy
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, parallel external control, retrospective real-world study. The study will assess the efficacy and safety of its Category 2.4 product, sirolimus, in epilepsy related to nodular sclerosis…
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Huadong Medicine’s Arcalyst (Rilonacept) Filing for CAPSs Accepted by China’s NMPA
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Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted its market filing for Arcalyst (rilonacept) for the treatment of cryo-pyrin-associated periodic syndromes (CAPSs). The drug is specifically filed for approval in treating familial cold autoimmune syndrome…
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SanegeneBio Partners with Huadong Medicine to Develop RNAi Therapeutics for Metabolic Diseases
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Suzhou-based RNA interference (RNAi) therapeutics developer SanegeneBio has entered into a partnership with compatriot firm Huadong Medicine Co., Ltd (SHE: 000963). The collaboration will utilize SanegeneBio’s Ligand and Enhancer Assisted Delivery (LEAD) technology platform to develop small interfering RNA (siRNA) drugs targeting chronic metabolic diseases, with the potential to expand…
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Huadong Medicine’s Elahere Accepted for NMPA Review in China for Ovarian Cancer Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted the market filing for its antibody drug conjugate (ADC) Elahere (mirvetuximab soravtansine), targeting folate receptor α (FRα). This marks a significant step towards making the treatment available for patients in China. Acquisition…
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Huadong Medicine Secures Global Licensing Agreement for ATGC-110 Botulinum Toxin A Injection
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China-based Huadong Medicine Co., Ltd. (SHE: 000963) has announced a strategic licensing agreement with South Korea’s ATGC, granting Huadong exclusive global rights (excluding India) to ATGC’s botulinum toxin A injection, ATGC-110. The agreement also provides a non-exclusive license for South Korea, encompassing clinical development, regulatory filing, and commercialization rights across…
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Huadong Medicine’s Subsidiary Viora Ltd’s V20 Accepted for NMPA Review
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted a Category III market filing for its wholly owned subsidiary Viora Ltd’s V20 optical radiofrequency therapy instrument. This development marks a significant step forward for the company’s entry into the Chinese medical…
