PharmaFocus Today – Page 17 – media

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
- 167
- 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
- 183
- 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
- 175
- 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
- 162
- 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
- 246
- 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
- 152
- August 3, 2026
While Da Vinci Remains in “Remote Control” Mode, Cornerstone Robotics Has Evolved to “Autonomous Operation”—A Technological Leap for Domestic Surgical Robots

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 ...
- Source: drugdu
- 203
- July 31, 2026
Carbamazepine Extended-Release Tablets (II) Receive Drug Registration Certificate

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
- Source: drugdu
- 169
- July 31, 2026
Levocarnitine Oral Solution Receives Drug Registration Certificate

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
- Source: drugdu
- 148
- July 31, 2026
Application for drug registration and marketing authorization of dapagliflozin tablets accepted

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
- Source: drugdu
- 140
- July 31, 2026

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