On July 29, according to the CDE website, the marketing application for injectable Ruzetatoprolol (RHR-A2009) submitted by Suzhou Shengdiya Biopharmaceutical Co., Ltd., a subsidiary of Hengrui Medicine, was accepted. Based on its clinical progress, the indication for this application is speculated to be: EGFR-mutant advanced non-small cell lung cancer. Lung cancer is the leading cause of cancer-related deaths worldwide, with non-small cell lung cancer (NSCLC) accounting for as much as 85%. According to data from Yaozhi, the market for NSCLC treatment drugs in my country continues to expand, with total sales exceeding RMB 84.5 billion in 2025 and reaching RMB 21.445 billion in Q1 2026, representing a year-on-year increase of 8.55%, indicating huge potential in the market. SHR-A2009, a HER3 ADC drug independently developed by Hengrui Medicine, is composed of a fully human HER3 monoclonal antibody and a DNA topoisomerase I inhibitor, precisely targeting tumor cells. In May of this ...
Boston Scientific recently announced that it will launch a global restructuring plan this year. 01 $800 million: Saving money with one hand and spending money with the other. According to documents filed by Boston Scientific with the SEC, this global restructuring plan is expected to officially launch in 2026, with an execution period spanning nearly four years and a target of being largely completed by the end of 2029. The restructuring covers four main areas: global supply chain optimization, capacity reallocation among production bases, systemic transformation of specific functions, and organizational restructuring to ensure suitability. Financially, Boston Scientific anticipates that the restructuring will generate $700 million to $800 million in pre-tax costs, of which approximately $600 million to $700 million will be actual cash costs to be incurred in the future. Breaking down the costs, severance pay is estimated at $275 million to $300 million, production line relocation-related expenses are ...
Drugdu.com expert’s response: The domestic NMPA registration process for medical devices adopts three differentiated procedures based on the product risk level, as detailed below: I. Pre-procedure for Classification Definition First, clarify the risk category of the product: Class I medical devices are subject to filing management, while Class II and Class III medical devices are subject to registration management. If the product attributes are ambiguous, you may first apply to the drug regulatory authority for classification definition, and initiate subsequent registration procedures only after obtaining a clear category determination result. II. Core Procedures for Classification-based Registration Class I Medical Device Filing: Prepare documents including product technical requirements, safety risk analysis, and production system-related materials, and submit the filing application to the municipal drug regulatory authority. A filing certificate can be obtained quickly if the documents are compliant, with no clinical trials required. Class II Medical Device Registration: Complete R&D and ...
For over two decades, the Da Vinci system has monopolized the global market for laparoscopic surgical robots, commanding prices as high as 20–30 million RMB per unit. This massive supply gap has created a historic opportunity for domestic alternatives. The globalization strategy of Cornerstone Robotics offers a valuable case study for the industry. In the first half of 2026, overseas shipments of Chinese laparoscopic surgical robots exceeded 154 units, accounting for 81% of the total volume for that period. Specifically, Cornerstone Robotics’ shipment breakdown—comprising four new domestic installations and five new installations across Hong Kong and international markets—clearly demonstrates that the overseas expansion of domestic surgical robots has moved beyond the proof-of-concept stage into a phase of tangible realization involving orders, installations, and clinical application. 01 The Hong Kong Pivot: A “Clinical Touchstone” of High Standards To understand Cornerstone Robotics’ overseas expansion strategy, one must first grasp the strategic importance ...
ST Renfu(600079.SH) announced that its subsidiary, Yichang Renfu, recently received a Drug Registration Certificate for Carbamazepine Extended-Release Tablets (II) issued by the National Medical Products Administration. This drug is primarily used to treat epilepsy and trigeminal neuralgia. https://finance.eastmoney.com/a/202607273822088834.html
Nanfang Finance News, July 28th – Progen PharmaceuticalsThe company announced that its controlling subsidiary, Zhejiang Procon Pharmaceutical Co., Ltd., received a Drug Registration Certificate for Levocarnitine Oral Solution issued by the National Medical Products Administration. This product is used to treat primary systemic carnitine deficiency, and also for the short-term and long-term treatment of secondary carnitine deficiency caused by congenital metabolic abnormalities. https://finance.eastmoney.com/a/202607283823563474.html
People’s Finance News, July 27 – Saisheng PharmaceuticalOn July 27, (300485) announced that its subsidiary, Saier Biotech, recently received an “Acceptance Notice” from the National Medical Products Administration (NMPA) for its application for registration and marketing authorization of dapagliflozin tablets for domestic production. This drug lowers blood sugar by inhibiting renal tubular glucose reabsorption and promoting urinary glucose excretion. Monotherapy carries a low risk of hypoglycemia, does not cause weight gain, has mild gastrointestinal reactions, and may protect pancreatic β-cell function by reducing glucotoxicity. https://finance.eastmoney.com/a/202607273822093693.html
On July 27, China Biopharmaceutical (01177) announced that it had signed a joint venture agreement with Indonesian listed company PT Tempo Scan Pacific Tbk (Tempo Scan) to jointly establish a joint venture company PT TEMPO CTTQ BIOPHARMACEUTICAL INDONESIA (TCBI). Sino Biopharmaceutical holds a 51% stake in TCBI, while Tempo Scan holds a 49% stake. The joint venture will combine Sino Biopharmaceutical’s strengths in innovative R&D and product pipeline with Tempo Scan’s localized capabilities in Indonesia, including manufacturing, regulatory registration, market access, sales and marketing, and distribution networks. The announcement stated that both parties are currently advancing multiple specialty drugs and innovative drugs.The registration and listing process has been completed, with some products already approved and several others under review. In addition to commercial cooperation, both parties will continue to explore further cooperation opportunities, including academic exchanges, local clinical development, production technology transfer, and future localized production. The establishment of the ...
People’s Finance News, July 30th – Changchun High & New Technology Industries Group Co., Ltd.(000661) announced on July 30 that its subsidiary, Jinsai Pharmaceutical, recently received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration, and the application for registration of the domestic production of GenSci144 tablets by Jinsai Pharmaceutical has been approved. GenSci144 tablets are an oral small molecule inhibitor targeting the neutral amino acid transporter SLC6A19, independently developed by Jinsai Pharmaceutical. It is registered as a Class 1 chemical drug and is intended for the treatment of chronic kidney disease (CKD). https://finance.eastmoney.com/a/202607303826738322.html
On July 30, Dongyangguang Pharmaceutical (06887) announced that its independently developed insulin degludec injection has received marketing approval from the National Medical Products Administration (NMPA). The drug is available in both cartridge and pre-filled injection pen versions. Insulin degludec injection is a fourth-generation long-acting basal insulin analog with a half-life of approximately 25 hours and a duration of action exceeding 42 hours, allowing for once-daily dosing to meet the entire day’s basal insulin requirements. Furthermore, this drug is superior to insulin glargine in terms of glucose-lowering curve stability and the incidence of hypoglycemia. With the launch of insulin degludec injection, the company now offers six insulin products in the Chinese market, covering three major clinical application scenarios: basal, prandial, and premixed insulin. The company is also pursuing international registration for other insulin products to expand its international market share. https://finance.eastmoney.com/a/202607303826929962.html
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