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China’s Hainan Free Trade Port Implements ‘Zero Tax’ on Medical Imports for Designated Entities
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In a joint effort to bolster healthcare services, China’s Ministry of Finance, National Health Commission (NHC), General Administration of Customs, State Taxation Administration, and National Medical Products Administration (NMPA) have announced a “zero tax” policy on drugs and medical devices imported through the Hainan Free Trade Port. The initiative targets…
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Former Hainan Medical University President Li Jingquan Expelled for Serious Disciplinary Violations
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Hainan’s disciplinary inspection committee has announced the expulsion of Li Jingquan, the former president of the First Affiliated Hospital of Hainan Medical University, from the Communist Party and public office due to serious violations of discipline and law. Li was found to have committed multiple infractions, including accepting gifts and…
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Israeli Hair Transplant Innovator Hairstetics Launches First Procedure in Asia at Hainan Hospital
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Hairstetics, an Israeli innovator in the non-absorbable polyamide hair transplant sector, has achieved a milestone with the implementation of its system at Hainan Boao LuYi Hospital, marking the first use case in Asia. The company’s cutting-edge technology addresses the complex and often slow-progressing condition of female androgenetic alopecia, a disease…
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Roche’s Alzheimer’s Disease Diagnostic Kits Gain Approval in Hainan, Set for Use in Shanghai Ruijin Hospital
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Swiss pharmaceutical and diagnostics giant Roche (SWX: ROG) has received approval from the Hainan Medical Products Administration for its suite of Alzheimer’s disease (AD) cerebrospinal fluid diagnostic kits. The approved products include Elecsys β-Amyloid (1-42) CSF II, Elecsys Phospho Tau (181P) CSF, Elecsys Total Tau CSF detection reagents, along with…
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Beijing Launches Bio-Park: A New Hub for International Pharmaceutical Innovation
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Beijing has unveiled an ambitious plan to construct Bio-Park, a state-of-the-art international pharmaceutical innovation park located in Beijing E-Town, during the Boao Forum for Asia. The initiative aims to establish a hub for high-energy innovation resources, support the development of high-value innovative products, and foster an efficient innovation ecosystem. Bio…
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Shanghai Ruijin Hospital’s Hainan Subsidiary Adopts ANI Pharmaceuticals’ Veregen for HPV Treatment
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ANI Pharmaceuticals’ Veregen, a topical ointment derived from green tea extract (catechins), has been implemented by Shanghai Ruijin Hospital’s Hainan subsidiary. Marking a significant step for the botanical drug in China, Veregen is the first such drug approved by the US FDA since 1962 and is already in use across…
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Eisai’s Next-Gen SERD, Orserdu, Begins Real-World Study in Shanghai Ruijin Hospital’s Hainan Subsidiary
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Shanghai Ruijin Hospital’s Hainan subsidiary has initiated a real-world study for Orserdu (elacestrant), a next-generation selective estrogen receptor degrader (SERD) originally developed by Eisai (TYO: 4523). The drug was transferred to Radius Health for global development back in 2006. In a strategic move in July 2020, the Menarini Group, based…
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HOB Biotech Receives NMPA Approval for Clinical Trials of MM09 Sublingual Spray
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Jiangsu-based HOB Biotech Group Corp., Ltd (SHA: 688656) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its MM09 sublingual spray. The product is intended to target indications such as mild to moderate asthma and allergic rhinitis/nasal conjunctivitis, with a focus on…
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Eslicarbazepine Makes First Appearance in China at Sichuan University’s West China Lecheng Hospital
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Eslicarbazepine, a voltage-gated sodium channel blocker, co-developed by Bial-Portela, Eisai, and Sumitomo Pharma, was first prescribed at the West China Lecheng Hospital of Sichuan University late last month. This epilepsy therapy marks the first special novel drug program implemented through the “first pilot, first trial” policy of the Boao Lecheng…
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Boao Lecheng Approves Use of Sanofi’s Tzield as First-Line Therapy for Type 1 Diabetes Delay
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Tzield (teplizumab), recognized as the world’s first and only targeted therapy for delaying the onset of type 1 diabetes, has received approval for use in the Boao Lecheng medical tourism pilot zone as a clinically urgently needed import drug. Developed by French pharmaceutical giant Sanofi, Tzield is indicated for use…
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Gloria Bio’s Motixafortide Approved as Urgently Needed Import Drug by Hainan Medical Products Administration
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Guangzhou Gloria Biosciences Co., Ltd, a biopharmaceutical company based in China, has received approval from the Hainan Medical Products Administration for its CXCR4 antagonist motixafortide (BL-8040) as a special drug for import due to clinical urgency. The drug will be implemented and administered by Hainan Boao Lu Medical Hospital, a…
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Grand Pharmaceutical Group Ltd’s SIR-Spheres Set to Reach Wider Patient Base Through MediTrust Health Deal
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Grand Pharmaceutical Group Ltd (HKG: 0512), a leading pharmaceutical company based in China, has announced a strategic partnership with MediTrust Health, an insurance, financing, and direct-to-patient pharmacy subsidiary of Shanghai Pharmaceuticals Holding Co., Ltd. This collaboration will focus on integrating Grand Pharma’s 90Y product into various commercial insurance schemes, aiming…
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Sperogenix Launches Early Access Program for DMD Therapy Agamgree in Hainan
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Switzerland-based Santhera Pharmaceuticals (SWX: SANN) has announced that its Chinese partner Sperogenix Therapeutics has initiated an early access program (EAP) for the rare disease therapy Agamgree (vamorolone) in Hainan’s Bo’ao Lecheng Pilot Zone, with the first patients now receiving treatment for Duchenne muscular dystrophy (DMD). Sperogenix secured the rights to…
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Novartis’s Tabrecta Earns NMPA Nod for MET-Positive Advanced NSCLC in China
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Swiss pharmaceutical titan Novartis has secured marketing approval from China’s National Medical Products Administration (NMPA) for its drug Tabrecta (capmatinib), intended for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a mesenchymal–epithelial transition (MET) exon 14 skipping mutation, who have not received…
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InnoCare’s Tafasitamab-Lenalidomide Combo on Track for Priority Review in China for DLBCL Treatment
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The Center for Drug Evaluation (CDE) website has indicated that InnoCare (HKG: 9969; SHA: 688428), a biopharmaceutical company based in China, is on track to receive priority review status for its drug candidate Minjuvi (tafasitamab) in combination with lenalidomide. This treatment is intended for adult patients with recurrent or refractory…
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Parexel Partners with Ruijin Hospital Hainan Subsidiary to Enhance Real-World Evidence in Drug Development
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Parexel, a U.S.-based contract research organization (CRO), has entered into a partnership with Shanghai Ruijin Hospital’s Hainan subsidiary. This collaboration aims to explore the use of real-world data (RWD) and real-world evidence (RWE) to facilitate the accelerated approval of drugs, thereby increasing Chinese patients’ access to innovative medications and therapies.…
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Medtronic’s RDN System Symplicity Spyral Earns First-Ever NMPA Approval
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Medtronic (NYSE: MDT), the US-Irish medical device giant, has announced that its Symplicity Spyral renal denervation (RDN) system has become the first of its kind to receive market approval from China’s National Medical Products Administration (NMPA). The company celebrates this milestone, which positions it at the forefront of the RDN…
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Bristol-Myers Squibb’s Camzyos Approved by China’s NMPA for Hypertrophic Cardiomyopathy Treatment
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Bristol-Myers Squibb (BMS; NYSE: BMY) has received marketing approval from China’s National Medical Products Administration (NMPA) for its innovative drug Camzyos (mavacamten) for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) graded as II to III under the New York Heart Association (NYHA) functional classification. The drug is indicated…
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China Medical System’s Opzelura Approved in Macau for Vitiligo Treatment
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China Medical System Holdings (CMS; HKG: 0867) has announced that it has received market approval in Macau for Opzelura (ruxolitinib) cream, a topical treatment indicated for patients aged 12 and above with non-segmental vitiligo involving the face. Opzelura, a topical Janus kinase (JAK) inhibitor, was initially approved in the U.S.…
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Hainan Medical Zone Launches ‘Lecheng Global Special Medical Insurance’ for Wider Drug Access
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The Hainan Boao Lecheng International Medical Tourism Pilot Zone has launched the “Lecheng Global Special Medical Insurance,” a new initiative that allows immediate patient enrollment. In conjunction with this launch, the Hainan Boao Lecheng Medical and Commercial Integration Research and Development Center, H2 Global Assistance Sdn Bhd, and Yuan Xin…
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Beijing Unveils Comprehensive Measures to Boost Innovative Medicine Development
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The Beijing Municipal Medical Insurance Bureau, in conjunction with eight other bureaus, has announced a set of Measures designed to “Support the High-Quality Development of Innovative Medicine in Beijing.” Released on April 7, 2024, these Measures are open for public feedback until April 9 and encompass a wide range of…
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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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China’s National Joint Procurement Office Unveils Renewed Insulin Procurement Contracts
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The National Joint Procurement Office in China announced the upcoming renewal of drug procurement contracts for insulin products previously involved in the volume-based procurement (VBP) program. The renewal process is set to commence on April 23, 2024, with the procurement cycle valued at RMB 11.5 billion (USD 1.59 billion). The…
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InnoCare Pharma Reports 2023 Revenue Growth and Pipeline Expansion
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InnoCare Pharma (HKG: 9969; SHA: 688428), a Beijing-based biotech company, has released its financial report for 2023, recording RMB 739 million (USD 102.2 million) in revenues and RMB 672 million (USD 92.9 million) in product sales, marking increases of 18.09% and 18.5% year-on-year (YOY), respectively. The company’s research and development…
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China’s National Joint Procurement Office Announces Renewal of Insulin Procurement Contracts Valued at $1.59 Billion
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The National Joint Procurement Office in China has announced the renewal of drug procurement contracts for insulin products under the volume-based procurement (VBP) program, with the renewal process scheduled for April 23, 2024. The procurement cycle is valued at RMB 11.5 billion (approximately USD 1.59 billion), and the winning bids…
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AstraZeneca’s Soriot Discusses US BioSecure Act’s Impact Amid China Expansion Plans
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Pascal Soriot, CEO of AstraZeneca (NASDAQ: AZN), addressed the potential implications of the US BioSecure Act in an interview with Bloomberg during the Boao Forum for Asia in China this week. Soriot expressed that, should the act pass, “It will not necessarily affect us,” citing the “very segmented” nature of…
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China Medical System Gets Green Light for Phase III Clinical Trial of Opzelura in Atopic Dermatitis
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China Medical System Holdings (CMS; HKG: 0867) has received approval from the National Medical Products Administration (NMPA) to commence a Phase III clinical study for its Opzelura (ruxolitinib) cream, which is indicated for the treatment of atopic dermatitis (AD). This development marks a significant step forward for CMS in expanding…
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ARSMO Plastic Aesthetic Hospital Introduces Liquid PCL Implant GOURI in Hainan
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ARSMO Plastic Aesthetic Hospital Holding Co., Ltd. has announced the inaugural application of GOURI, a fully liquid polycaprolactone (PCL) based dermal filler, in its Hainan-based unit. GOURI is a renewable material that utilizes CESABP technology, allowing it to be fully liquid and to decompose gradually, thereby promoting the natural regeneration…
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Boao Yiling Life Care Center Launches Innovative Dental Technologies Under Pilot Medical Policy
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Boao Yiling Life Care Center has successfully completed the inaugural use of a dental comprehensive treatment table and a dental healing cap (MED) licensed from Germany’s Sirona Dental Systems GmbH and Israel’s Magdent Ltd. This milestone was achieved under the “first pilot, first trial” special medical policy in the Boao…
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InnoCare Makes Minjuvi Combo Treatment Available to Patients in China’s GBA
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InnoCare (HKG: 9969; SHA: 688428), a China-based biopharmaceutical company, has announced that the combination treatment of Minjuvi (tafasitamab) plus lenalidomide is now accessible to patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT) in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA).…
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Hainan Province Unveils Measures to Support Innovative Drugs and Medical Devices Development
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Hainan provincial bureaus, including the Healthcare Security Administration (HSA), Healthcare Commission, and Medical Products Administration, along with five other bureaus, have jointly issued a set of Measures to “Support the Development of Innovative Drugs and Medical Devices in Hainan Province.” The initiative aims to ensure seamless integration between the market…
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BMS’s Mavacamten Used to Treat First Patient with Hypertrophic Cardiomyopathy in Hainan
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced that the first patient with obstructive hypertrophic cardiomyopathy (oHCM) has been treated using its drug mavacamten at Ruijin Hospital’s Hainan branch. Mavacamten, the world’s first cardiac myosin inhibitor, received approval from the Hainan Medical Products Administration for special entry into the Hainan Bo’ao…
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China Grand Pharmaceuticals Secures Distribution of Sirtex’s SIR-Spheres for Liver Cancer
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) announced that its subsidiaries, Beijing Purevalley Biotechnology Co., Ltd and Chengdu Purevalley Biotechnology Co., Ltd, have entered into a distribution agreement with Australian firm Sirtex Medical Ltd. This agreement centers on the distribution of Sirtex’s SIR-Spheres (Y-90 microsphere) injection, a…
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China Medical System Gets NMPA Green Light for Phase III Vitiligo Study with Ruxolitinib Cream
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China Medical System Holdings (CMS; HKG: 0867) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical study for its Opzelura (ruxolitinib) cream for the treatment of non-segmental vitiligo. Opzelura, a topical Janus kinase (JAK) inhibitor, was approved in the…
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China’s CDE Expands Market Approval Services with Two New Regional Windows
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The China Center for Drug Evaluation (CDE) has announced the establishment of two additional external acceptance service windows at the National Medical Products Administration (NMPA) subcenters in the Yangtze River Delta and the Greater Bay Area. These service windows will commence operations from December 1, 2023, and will be responsible…
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China’s NMPA Accepts EOC Pharma Group’s Filing for Vascepa (Icosapent Ethyl) for Review
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The China-based EOC Pharma Group has achieved a significant milestone with the National Medical Products Administration (NMPA) accepting its market filing for Vascepa (icosapent ethyl) for review. The drug is targeted for the prevention and reduction of cardiovascular event risks in adult patients with hypertriglyceridemia who are diagnosed with cardiovascular…
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Ji Xing Pharmaceuticals Partners with WuXi STA for Sterile Nasal Spray Production
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Shanghai-based Ji Xing Pharmaceuticals, backed by RTW Investments, has formed a strategic partnership with WuXi STA, a subsidiary of WuXi AppTec (HKG: 2359, SHA: 603259), to establish a sterile nasal spray production line. This collaboration aims to leverage the strengths of both companies, with the new production facility set to…
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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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CANbridge’s Maralixibat Receives Priority Review for PFIC Treatment in China
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China-based rare disease specialist CANbridge Pharmaceuticals Inc. (HKG: 1228) has announced that a New Drug Application (NDA) for its maralixibat (CAN108) has been accepted for review by the National Medical Products Administration (NMPA) in China, with the added benefit of priority review status. This marks a significant step forward in…
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Cochlear’s Artificial Cochlear Sound Processor Gains NMPA Approval for Marketing in China
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Australia-based Cochlear has received marketing approval from the National Medical Products Administration (NMPA) for its artificial cochlear sound processor, as announced by the Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration. This innovative product is designed to convert received sounds and transmit electrical stimulation to the auditory nerve through…
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Hainan Implements New Regulations for Import Drugs and Medical Devices in Medical Tourism Zone
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The Hainan Medical Products Administration, in conjunction with Hainan’s Health Commission Bureau, has unveiled a comprehensive set of measures to regulate the import of urgently needed drugs and medical devices for use outside of hospitals within the Hainan Boao Lecheng International Medical Tourism Pilot Zone. This initiative aims to streamline…
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China’s NHC Expands Rare Disease List, Includes 21 Cancer Types
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The National Health Commission (NHC) of China has released an updated national list of rare diseases, doubling the number of conditions to 86, including 21 cancer types. This marks the first update to China’s orphan disease schedule since the initial list of 121 conditions was introduced in 2018. Market Access…
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HutchMed Advances Tazverik Phase II Trial for Follicular Lymphoma in China
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China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced the completion of patient enrollment in a bridging study for Tazverik (tazemetostat) in China. Tazverik, originated by US firm Epizyme Inc., was licensed to HutchMed for development in Greater China in an agreement reached in August 2021. Tazverik’s Background and Previous ApprovalsThe…
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Merck & Co. Becomes First Multinational to Register Unit in Hainan’s Lecheng Pilot Zone
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US pharmaceutical major Merck, Sharp & Dohme Inc., (MSD, NYSE: MRK) has officially registered a unit in the Lecheng pilot zone of Boao, Hainan province, marking a significant milestone as the first multinational company to obtain a business license in the city. Hainan Boao Lecheng International Medical Tourism Pilot Zone’s…
