According to the CDE website, Dongyangguang Pharmaceutical’s application for generic version of Xinuo amino acid tablets has been accepted as a Class 4 generic drug. So far this year, Dongyangguang Pharmaceutical has six products under review for approval. Sinuosine tablets are used to treat focal seizures (partial seizures) in adults, especially for patients who do not respond to or cannot tolerate conventional antiepileptic drugs (ASM). In recent years, the sales volume of antiepileptic drugs in China’s three major terminals and six major markets (see the end of this article for the statistical scope) has exceeded 7 billion yuan, with a slight year-on-year decline in the first half of 2026. In terms of administration routes, the market share of oral medications continues to expand, accounting for more than 90% in the first half of 2026. Levetiracetam tablets, sodium valproate extended-release tablets (I), and lamotrigine tablets are the top three products. According ...
Recently, MicroPort Medical Sciences Co., Ltd. (hereinafter referred to as “MicroPort Medical”) officially announced a series of senior personnel changes. According to the announcement, the company’s founder has stepped down from his position as director and related positions, remaining as Chief Scientific Officer. At the same time, the board of directors has appointed a senior veteran within the company as Executive Director and CEO. Currently, the above-mentioned personnel adjustments have fully taken effect. Trading suspension turmoil New coach takes office The underlying reason for this series of high-level personnel turmoil stems from the suspension of trading of MicroPort Medical Systems Co., Ltd. On September 1st, trading in four Hong Kong-listed companies—MicroPort Medical, MicroPort Robotics, MicroPort CardioFlow, and MicroPort Brain Science—was simultaneously suspended. While the immediate trigger was the failure to disclose their 2026 interim results on schedule, the root cause of the delay pointed to audit and accounting matters related ...
In 2026, China’s innovative drug industry continued to enter a new phase of commercializing innovative achievements. Data from the National Medical Products Administration shows that 76 innovative drugs were approved for marketing in China in 2025, a record high; in the first half of 2026, another 38 innovative drugs were approved. As more innovative products enter the market, the focus of industry competition is gradually shifting from the accumulation of R&D pipelines to product commercialization, profitability, and sustainable growth capabilities. For Hengrui Medicine, what’s more noteworthy than its current performance is who will take over the next round of growth. On one hand, some of its earlier-marketed innovative drugs face increasingly fierce market competition; on the other hand, new products, new indications, and global collaborations are making continuous progress. Amidst the transition between old and new growth drivers, can Hengrui unlock new growth opportunities? Significant quarter-on-quarter growth, What new signals ...
Nanfang Daily News, October 29th – Hutchison MediPharma (00013.HK) issued a voluntary announcement stating that its sorbipinib has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of primary immune thrombocytopenic purpura (PETP). Solepinib is a novel, highly selective oral spleen tyrosine kinase inhibitor. If approved, the drug will be eligible for seven years of market exclusivity in the U.S. from the date of approval, and will be eligible for various development incentives, including tax credits. In addition, two new drug applications for sorbipinib in China, for the treatment of PETP and warm antibody-type autoimmune hemolytic anemia, are currently under review. Source: https://finance.eastmoney.com/a/202610293913017516.html
Ascletis Pharma announced on the 29th that it has achieved positive top-line results in its Phase II US study evaluating the oral small-molecule GLP-1 receptor (GLP-1R) agonist ASC30 for the treatment of type 2 diabetes. This Phase II study was a 13-week US study designed to evaluate the efficacy, safety, and tolerability of once-daily oral ASC30 tablets in 100 diabetic subjects. Regarding the primary endpoint, ASC30 achieved a statistically significant and clinically meaningful reduction in glycated hemoglobin (HbA1c) in diabetic subjects compared to placebo (p < 0.0001). Based on the efficacy estimand, at week 12, the placebo-adjusted reduction in HbA1c from baseline (least squares mean) was 1.7%, 1.6%, and 1.7% in the 40 mg (n=20), 60 mg (n=29), and 80 mg (n=28) dose groups, respectively. The baseline mean HbA1c was 8.3%. Source: https://finance.eastmoney.com/a/202610293912992532.html
Organiser:Informa Time:October 28th – 29th, 2026 Address:1301 2nd Avenue South Minneapolis, MN 55403 USA Exhibition hall:Minneapolis Convention Center Product range: Medical Supplies: Anesthesiology and pulmonary medications, home care, cardiovascular department, orthopedic surgical instruments, radiology and medical imaging, emergency care, surgical instruments, sports medicine and rehabilitation therapy, in vitro diagnostic equipment, general hospital supplies and equipment Medical Materials & Accessories: New materials, 3D printing, robotics and automation, silicone, mobile power solutions, essential considerations to avoid medical device battery failures, innovative metal 3D printing for medical devices, intelligent layering, integrated product design and development services Medical Devices: Medical technical equipment, laboratory instruments and equipment, medical electronic devices, medical diagnostic equipment, ophthalmic equipment and protective products, surgical instruments, first aid and emergency equipment, hospital and dental medical equipment, dental service equipment, disposable medical products, disposable medical products for hospital and home use, data processing systems for hospital and dental medical use, dental ...
Drugdu.com expert’s response: When conducting foreign trade in pharmaceuticals and medical devices, some enterprises often encounter such a situation: after their products are launched on B2B platforms, they receive inquiries from overseas buyers one after another. Some ask for prices, some request COAs and product specifications, and others further inquire about packaging, purchase quantities and delivery lead times. Suppliers provide the required documents and complete quotations as requested, yet one or two months pass without any actual orders being formed. At this point, enterprises will inevitably begin to doubt the effectiveness of their promotion efforts. Clearly, there are already consultations, but why have no transactions been closed? Are the buyers insincere about procurement, or are the products uncompetitive? Is it still necessary to continue promoting this product? For pharmaceutical B2B businesses, there is often a procurement evaluation process between an inquiry and a confirmed order. Especially for products like APIs, ...
Organiser:Korea E&EX Exhibition Company Time:October 23rd – 25th, 2026 Address:55 Apec-ro, Haeundae-gu, Busan, 612-704, South Korea Exhibition hall:Busan Exhibition & Convention Center Product range: Medical Equipment: Medical technical equipment, consumables, medical electronic devices, ophthalmic equipment, protective products, surgical instruments, first aid and emergency equipment, hospital and dental medical equipment, dental service equipment, disposable medical products, disposable medical products for hospital and home use, data processing systems for hospital and dental medical use, dental and orthopedic rehabilitation equipment In Vitro Diagnosis & Clinical Laboratory Equipment: Endoscope systems, B-ultrasound examination equipment, ENT therapeutic instruments, dynamic analysis instruments, integrated laboratory solutions, clinical diagnostic equipment, diagnostic reagents, precision medicine, POCT, home diagnostic equipment, clinical laboratory equipment Rehabilitation & Nursing Supplies: Orthotic devices, walkers, hearing aids, warning guide devices, manual wheelchairs, electric wheelchairs, crutches, walking aids, massagers, health-care clothing, fitness equipment, training machines, wrist guards and protective gear, smart wearables, neck fixation straps, traction ...
Drugdu.com expert’s response: When enterprises apply for domestic registration of Class II active medical devices, they need to focus on demonstrating the product’s safety, effectiveness and quality controllability. Compared with some passive medical devices, active products usually involve functions such as power supply, circuits, software, control systems and energy output. Therefore, in the registration review process, electrical safety, electromagnetic compatibility (EMC), software verification and product performance are the key areas of concern. In accordance with the Regulations on Administration of Medical Device Registration and Filing of the National Medical Products Administration (NMPA) and Announcement No. 121 of 2021, domestic Class II medical devices are subject to registration review and approval by the provincial drug regulatory department where the enterprise is located, while imported Class II medical devices are reviewed and approved by the NMPA. The registration application materials shall be prepared in accordance with the specified catalogue and format, and the technical ...
On October 26, Fuyuan Pharmaceutical (601089) announced that it had received a Drug Registration Certificate from the National Medical Products Administration (NMPA) for its rotigotine transdermal patch (strengths: 2 mg/24 hours and 4.5 mg/patch), approving the manufacture of the product. The rotigotine transdermal patch is indicated for monotherapy of the signs and symptoms of early-stage idiopathic Parkinson’s disease, or in combination with levodopa at all stages of the disease. Rotigotine is a non-ergot dopamine receptor agonist. The transdermal patch delivers the drug continuously and steadily through the skin, helping to maintain stable plasma concentrations, reducing the peak-trough fluctuations common with oral dosing and improving morning motor symptoms. It is particularly suitable for patients with dysphagia or those requiring continuous overnight dosing. According to the announcement, the company’s cumulative R&D investment in this product amounted to RMB 15.7779 million. The approval will further enrich the company’s product pipeline and help enhance ...
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