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Sorapinib Receives Orphan Drug Designation from the U.S. FDA

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
- Source: drugdu
- 91
- October 29, 2026
Positive topline results from the US Phase II study of ASC30 for the treatment of type 2 diabetes

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
- Source: drugdu
- 85
- October 29, 2026
MD&M Minnesota

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 ...
- Source: drugdu
- 58
- October 29, 2026
【EXPERT Q&A】The product has received inquiries, but there are no orders for a long time. Is it still worth promoting?

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, ...
- Source: drugdu
- 73
- October 28, 2026
KIMES BUSAN

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 ...
- Source: drugdu
- 49
- October 27, 2026
【EXPERT Q&A】‌‌What are the mandatory core requirements for NMPA registration materials of Class II active medical devices?

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 ...
- Source: drugdu
- 97
- October 26, 2026
Rotigotine Transdermal Patch Receives Drug Registration Certificate, Expanding Its Parkinson’s Treatment Portfolio

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 ...
- Source: drugdu
- 121
- October 26, 2026
Qilu Pharmaceutical’s Changqiping® inhaled spray approved for market launch, adding a new option for maintenance treatment of COPD

Recently, Qilu Pharmaceutical’s tiotropium bromide inhalation spray (Changqiping® ) was approved for marketing by the National Medical Products Administration. It is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD, including chronic bronchitis and emphysema) and related dyspnea, improving the quality of life of COPD patients and reducing acute exacerbations. This approval represents another breakthrough for the company in the high-barrier drug-device combination field, further enriching its respiratory system product pipeline and providing new treatment options for clinical practice. COPD is a heterogeneous lung disease characterized by persistent airflow limitation and corresponding respiratory symptoms. Its core pathological changes include small airway lesions and lung parenchymal destruction. The main symptoms include chronic cough, sputum production, shortness of breath, or dyspnea. In my country, the prevalence of COPD is severe, becoming one of the major chronic diseases seriously endangering national health, alongside hypertension and diabetes. The prevalence of COPD in ...
- Source: drugdu
- 116
- October 26, 2026
First generic version of a novel pulmonary arterial hypertension treatment drug approved for marketing.

On October 22, 2026, according to the latest information on the official website of the National Medical Products Administration (NMPA) of China, the beraprost sodium sustained-release tablets submitted by Beijing Tide Pharmaceutical Co., Ltd. were approved for marketing. It is mainly used to treat pulmonary hypertension and improve symptoms such as ulcers, intermittent claudication, pain and coldness caused by chronic arterial occlusive disease.Pulmonary hypertension is a cardiovascular disease with high rates of disability and mortality. Patients experience progressively increasing pulmonary vascular load, eventually leading to heart failure. Idiopathic pulmonary arterial hypertension (IPAH), which has been included in my country’s first batch of rare disease catalogs, is an important type of PAH. Research data shows that without targeted treatment, the median survival of IPAH patients after the onset of symptoms is only 2.8 years.According to publicly available information, beraprost sodium is the world’s first oral prostacyclin (PGI2) derivative . It has ...
- Source: drugdu
- 89
- October 26, 2026
Another global medical device giant has officially announced its spin-off!

According to recent foreign media reports, Abbott announced the spin-off of its businesses and a downward revision of its full-year guidance after releasing its Q3 results. Abbott announced plans to spin off its nutrition business into an independent company by the end of 2027. The new independent company will have annual sales of $8.5 billion, 16,000 employees, and 14 manufacturing sites. Its product portfolio will include well-known brands such as Ensure (a nutritional supplement drink), PediaSure (a pediatric nutritional supplement), Glucerna (a diabetes management nutrition brand), and Similac (an infant formula brand). Daniel Salvadori, the current Executive Vice President and Group President of Mature Pharmaceuticals and Nutrition Products, will become the CEO of this independent company. The spin-off plan includes Abbott distributing shares of the independent nutrition company to Abbott shareholders. Upon completion of the spin-off, Abbott shareholders will hold shares in both Abbott and the independent nutrition company. It ...
- Source: drugdu
- 108
- October 26, 2026

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