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its stock price has shrunk by 90% from its issue price, and although it has finally received approval for its first product, the market landscape has already changed.

Kang Le Guardian (i.e., *ST Kang Le)(BJ920575, stock price 4.71 yuan, market value 1.323 billion yuan) has finally ushered in its long-awaited first commercial product. Delivery letter of drug approval certificate published by the National Medical Products Administration on July 30Information shows that the trivalent human papillomavirus vaccine from Health Guard (Kunming) Biotechnology Co., Ltd.(Escherichia coli) has been approved, with approval number S20260057, and approval date July 28. This product covers HPV types 16, 18, and 58. KangLeGuardian had been waiting for this moment for far too long. In March 2023, KangLeGuardian went public on the Beijing Stock Exchange with an issue price of 42 yuan per share, becoming the first HPV stock on the Beijing Stock Exchange. That was also a high point for HPV vaccines —more than 58 million doses were administered in China throughout the year, and HPV vaccines became the vaccine category with the largest increase ...
- Source: drugdu
- 76
- August 4, 2026
China’s first generic tiotropium bromide inhalation spray approved.

China Securities Intelligent Finance News: BrightGene Pharmaceutical(688166) announced on the evening of July 31 that its holding subsidiary, Aitemei (Suzhou) Pharmaceutical Technology Co., Ltd., recently received a Drug Registration Certificate for Tiotropium Bromide Inhalation Spray issued by the National Medical Products Administration. The specification is 60 sprays per bottle, the registration category is chemical drug category 4, and the drug approval number is valid until July 27, 2031. The announcement indicates that this drug is suitable for maintenance treatment of chronic obstructive pulmonary disease (COPD) and related dyspnea, and can reduce acute exacerbations of COPD. The original manufacturer is Boehringer Ingelheim, and currently only the original imported version is available on the market. The National Medical Products Administration (NMPA) website shows that there are currently no generic versions of this drug available in China, making Boehringer Ingelheim the first company to receive approval for its market launch in the country. ...
- Source: drugdu
- 66
- August 4, 2026
Ibrutinib tablets receiving drug registration certificate is considered equivalent to passing the consistency evaluation

China Securities Intelligent Finance Huabang Health(002004) announced on the evening of July 31 that its wholly-owned subsidiary, Chongqing Huabang Pharmaceutical Co., Ltd., recently received the Drug Registration Certificate for Ibrutinib tablets issued by the National Medical Products Administration. The specifications are 0.14g and 420mg, and the registration category is Class 3 chemical drug, which is regarded as passing the consistency evaluation of generic drug quality and efficacy. The announcement indicates that this drug is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy; patients with chronic lymphocytic leukemia/small lymphocytic lymphoma; patients with Waldenström macroglobulinemia who have received at least one prior therapy, or those who are unsuitable for chemoimmunotherapy .This product is a first-line treatment for patients with Waldenström macroglobulinemia; when used in combination with rituximab, it is suitable for the treatment of patients with Waldenström macroglobulinemia. The company stated that ...
- Source: drugdu
- 63
- August 4, 2026
Isaconazole Sulfate for Injection and Enzalutamide Tablets are expected to be selected in the 12th batch of national centralized procurement

　　China Securities Intelligent Finance News: XuanTai Pharmaceutical(688247) announced on August 4 that its products, Isaconazole Sulfate for Injection and Enzalutamide Tablets, which were jointly developed, are expected to be selected in the 12th batch of national centralized drug procurement. 　　According to the announcement, isaconazole sulfate for injection is indicated for the treatment of invasive aspergillosis and invasive mucormycosis in adults; enzalutamide tablets are indicated for the treatment of adult patients with metastatic hormone-sensitive prostate cancer, adult patients with non-metastatic castration-resistant prostate cancer at high risk of metastasis, and adult patients with metastatic castration-resistant prostate cancer who are asymptomatic or have mild symptoms and have not received chemotherapy after failure of androgen deprivation therapy. The proposed winning specifications for isaconazole sulfate for injection are 1 vial/box, and the proposed winning specifications for enzalutamide tablets are 40mg (56 tablets/box) and 80mg (28 tablets/box). The procurement period is from the date of implementation ...
- Source: drugdu
- 65
- August 4, 2026
EXPO MED

Organiser： Mexican Medical Association, Informa Time：August 18-20, 2026 Address：Conscripto 311, Colonia Lomas de Sotelo, Delegación Miguel Hidalgo, 11200 Mexico City Exhibition hall：Centro Banamex Product range: Medical Devices: Medical equipment, laboratory equipment and supplies, testing, analytical and diagnostic instruments and accessories, radiology, imaging, ultrasonography, electronic medical instruments, physical therapy, rehabilitation products, surgical and orthopedic technologies, monitoring instruments, ophthalmic equipment, dental equipment, medical furniture, medical consumables, hospital equipment Related Medical Categories: Medical safety service equipment, medical gases, information technology, software, adult products, pharmaceuticals, etc. About EXPO MED： Expo Med Mexico is the most professional and comprehensive industry event for medical supplies and pharmaceutical equipment in Mexico. It gathers global medical industry participants including hospitals, clinics and pharmacies, providing exhibitors with a professional sales platform. As a key local B2B healthcare exhibition, Expo Med not only boasts high attendance and fruitful outcomes, but also delivers new breakthroughs in innovation, academic exchanges and ...
- Source: drugdu
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- August 4, 2026
Leads Biolabs receives IND approval from the National Medical Products Administration for the treatment of metastatic colorectal cancer.

　　On August 3, Leads Biolabs announced on the Hong Kong Stock Exchange that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application for its independently developed candidate drug, Verizon (opatidisulfimab, a PD-L1/4-1BB bispecific antibody, LBL-024), for the treatment of metastatic colorectal cancer (mCRC). The approved clinical trial is an open-label, multicenter Phase Ib/II study designed to evaluate the safety and efficacy of Verizon in combination with other drugs for the treatment of mCRC. https://finance.eastmoney.com/a/202608033829221843.html
- Source: drugdu
- 74
- August 3, 2026
Submission of supplementary materials for serum-free iterative rabies vaccine completed.

Nanfang Finance News, August 3 – Aim Vaccine (06660.HK) issued a voluntary announcement stating that its wholly-owned subsidiary, Aim Honor (Ningbo) Biopharmaceutical Co., Ltd., has independently developed a serum-free iterative rabies vaccine .(Acceptance No.: CXSS2500044) The company has completed the submission of supplementary materials required by the Center for Drug Evaluation of the National Medical Products Administration, marking significant progress in the registration application process. The vaccine has previously passed the marketing registration application and on-site inspection, and has completed the unblinding of the Phase III clinical trial. The results show that its safety, immunogenicity, and duration of immunity all fully meet the preset evaluation standards; the company has obtained the corresponding product production license. In terms of background, current mainstream rabies vaccines use a serum-containing culture system, and residual animal serum can easily cause allergies and local adverse reactions. This vaccine, however, achieves an innovative cell culture process without ...
- Source: drugdu
- 65
- August 3, 2026
Hengrui Medicine’s HER3 ADC “Ruikang Luzettotatumab” has been submitted for marketing approval.

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 ...
- Source: drugdu
- 74
- August 3, 2026
Boston Scientific is investing $5 billion to begin “slimming down”.

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 ...
- Source: drugdu
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- August 3, 2026
【EXPERT Q&A】What is the domestic medical device registration (NMPA) process like?

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 ...
- Source: drugdu
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- August 3, 2026

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