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Xeltis AG Enrolls First Patient in US Pivotal Trial for aXess with FDA BTD Status
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Holland-based Xeltis AG has announced the enrollment of the first patient in a US-staged pivotal trial for its flagship product, aXess, which has been granted Breakthrough Device Designation (BTD) status by the US FDA. This marks a significant milestone in the development and potential approval of aXess, a novel medical…
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Grand Pharmaceutical Group Expands Distribution Partnership with Sirtex Medical in China
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Grand Pharmaceutical Group Ltd (HKG: 0512), a leading pharmaceutical company based in China, has announced an additional distribution agreement with Australian firm Sirtex Medical Ltd. The agreement involves Grand Pharmaceutical’s subsidiaries, Beijing Purevalley Biotechnology Co., Ltd, and Chengdu Purevalley Biotechnology Co., Ltd, which will exclusively distribute Sirtex’s SIR-Spheres (Y-90 microsphere)…
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China Grand Pharmaceutical Completes Phase III Clinical Study for Post-Cataract Surgery Treatment
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced the successful completion of a Phase III clinical study for its investigational drug, GPN00833, used for inflammation and pain management following cataract surgery in China, meeting all clinical endpoints. GPN00833: A Nanosuspension Eye Drop for Inflammation and PainGPN00833…
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China Grand Pharmaceutical Receives NMPA Approval for Innovative Adjustable Thrombectomy Stent
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China Grand Pharmaceutical and Healthcare Holdings Ltd (CGP; HKG: 0512) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its adjustable intracranial thrombectomy stent, marking a significant milestone as the first domestically produced device of its kind in China for the treatment of…
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CGP’s 2024 Interim Report Shows Robust Growth in Revenues and Profits, Highlighting R&D Focus
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HONG KONG—China Grand Pharmaceutical and Healthcare Holdings Ltd (CGP; HKG: 0512) has released its interim financial report for 2024, revealing a 5.4% year-on-year increase in revenues to HKD 6.05 billion (USD 776.7 million) in constant exchange rate terms. The profit attributable to the company’s owners surged 51.4% year-on-year to approximately…
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China’s SAMR Proposes Antitrust Guidelines to Regulate Pharmaceutical Industry
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The State Administration for Market Regulation (SAMR) in China has unveiled a draft proposal for “Antitrust Guidelines for the Pharmaceutical Industry” and is currently soliciting public feedback until August 23, 2024. This comprehensive document, encompassing 55 articles across seven sections, is designed to clarify the foundational principles of anti-monopoly law…
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China Grand Pharmaceutical Expands with Mitsubishi Tanabe Pharma and Baiji Pharma Acquisitions
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced the completion of a 100% stake change registration for Mitsubishi Tanabe Pharma Corporation’s Tianjin subsidiary, as well as for compatriot firms Nanchang Baiji Medicine Technology Co., Ltd. and Jiangxi Bai’an Baiyu Pharmaceutical Technology Co., Ltd, collectively referred to…
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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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CGP’s GPN00884 Myopia Drug Enters Phase I Clinical Trial with First Patient Dosed
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced the commencement of a Phase I clinical study for GPN00884, an innovative ophthalmic drug aimed at arresting the progression of childhood myopia, with the first patient now dosed. This randomized, double-blind, placebo-controlled, dose-escalation study is designed to evaluate…
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Grand Pharma Receives NMPA Approval for Global Phase III Study of RDC ITM-11 in GEP-NETs
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Grand Pharmaceutical Group Ltd (HKG: 0512), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct the COMPOSE study. This is a prospective, randomized, controlled, open-label, global multi-center Phase III study designed to assess the efficacy, safety,…
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China Grand Pharmaceutical Reports Robust 2023 Revenues and Pipeline Advancements
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has reported its financial results for 2023, with revenues reaching HKD 10.53 billion (USD 1.35 billion), marking a 15.8% year-on-year increase. The net profit stood at HKD 2.04 billion (USD 260.8 million), up by a modest 0.2% year-on-year. The company…
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China Grand Pharmaceutical Receives FDA Approval for Post-Surgical Ophthalmic Drug GPN00833
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its hormone nanosuspension eye drops GPN00833 (APP13007), designed for anti-inflammatory and analgesic effects following ophthalmic surgery. Additionally, the company has gained clinical trial…
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China Grand Pharmaceutical Gets NMPA Green Light for mRNA Cancer Vaccine ARC01 Phase I Study
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct an open-label, dosage escalation Phase I study for its therapeutic cancer vaccine ARC01 (A002). The study will assess the safety, tolerability, immunogenicity, pharmacokinetics, and…
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China Grand Pharma to Acquire 63% Stake in Duoputai for RMB 442 Million
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced its intention to acquire a 63% stake in Chongqing Duoputai Pharmaceutical Co., Ltd for RMB 442 million (approximately USD 62 million). This acquisition will elevate CGP Pharma’s ownership in Duoputai to 90%, granting the company full control over…
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China Grand Pharmaceutical to Acquire Majority Stake in Mitsubishi Tanabe’s Tianjin Subsidiary
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced its intention to acquire a 75.35% controlling stake in the Tianjin subsidiary of Japan-based Mitsubishi Tanabe Pharma Corporation for a consideration of HKD 400 million (USD 51 million). This strategic move signifies CGP’s expansion into a broader range…
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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 Grand Pharma’s Lava Liquid Embolic Agent Officially Commercialized in the US
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced the official commercialization of its subsidiary BlackSwan Vascular, Inc.’s innovative liquid embolic agent, Lava, in the United States. This marks a significant milestone for the company as it expands its presence in the US medical market. US Market…
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China Grand Pharma Initiates Phase III Trial for GPN00833 in Cataract Surgery Recovery
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced a significant milestone in the clinical development of GPN00833, with the first patient enrolled and dosed in a Phase III study. This multi-center, randomized, double-blinded, placebo-controlled, parallel group study is designed to assess the efficacy and safety of…
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China Grand Pharmaceutical Reports H1 2023 Revenues and Pipeline Progress
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has released its financial report for the first half of 2023, highlighting strong revenue growth and significant advancements in its clinical pipeline. The company recorded revenues of HKD 5.989 billion (USD 766 million) and net profits of HKD 1.124 billion…
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Grand Pharmaceutical’s GSP301 NS Meets Primary Endpoint in Phase III SAR Study
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that its Phase III study (GSP 301-308) for the Ryaltris compound nasal spray (GSP301 NS) in seasonal allergic rhinitis (SAR) has successfully reached its primary endpoint in China. Study Design and Patient EnrollmentThe randomized, double-blind, double-simulation, three-arm, multi-center, parallel-controlled Phase III…
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Grand Pharmaceutical Receives NMPA Approval for Generic Carbaglu for Hyperammonemia Treatment
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Italy’s Recordati’s Carbaglu (carglumic acid). This marks the first approval of such a generic drug in China, offering a treatment for hyperammoniaemia caused…
