PharmaFocus Today – Page 20 – media

CAR-T therapy, a “sky-high priced cancer treatment,” may see a breakthrough in commercial insurance pricing negotiations this year.

At approximately 3 PM today, during the on-site negotiations for the 2025 National Reimbursement Drug List and the discussion on innovative drugs covered by commercial insurance…At the price negotiation meeting, representatives from HeYuan Biotech, unable to hide their joy after concluding price negotiations, told reporters from Cailian Press, “We’ve reached an agreement,” but the final result will still be subject to the final announcement by the National Healthcare Security Administration. This means that CAR-T drugs, including HeYuan Biotech’s Nakiorenzai injection, are expected to achieve a breakthrough in this year’s price negotiations for innovative drugs covered by commercial insurance. HeYuan Biotech’s Nakiorenzai injection was approved for marketing in 2023, and five CAR-T drugs, represented by Nakiorenzai, have all passed the preliminary review for the innovative drug list covered by commercial insurance this year. Due to its high price, CAR-T therapy has failed to enter the “threshold” of national medical insurance negotiations for the past four years. ...
- Source: drugdu
- 96
- November 3, 2025
Hanyu Pharmaceuticals returned to profitability in the first three quarters, with overseas markets becoming the engine of growth.

Recently, Shenzhen Hanyu Pharmaceutical Co., Ltd.According to the third-quarter report of 2025 disclosed by Hanyu Pharmaceutical Co., Ltd. (hereinafter referred to as ” Hanyu Pharmaceutical “, 300199.SZ), the company suffered a net loss of 74.1171 million yuan in the quarter, a year-on-year decrease of 203.18%. However, the net profit for the first three quarters showed a significant increase, turning a profit compared to the same period last year. At the same time, the company’s cash flow continued to improve. According to the Economic Information Daily, Hanyu Pharmaceutical has suffered losses for three consecutive years, but its performance has continued to grow this year. It is currently accelerating its layout of peptide drugs, and overseas markets have become its growth engine. Net profit turned around year-on-year in the first three quarters Founded in April 2003, Hanyu Pharmaceutical is a national high-tech enterprise specializing in the research, development, production, and sales of ...
- Source: drugdu
- 109
- November 3, 2025
Strategic Cooperation Agreement Reached with Shengsi Biotechnology; Subsidiary Granted Exclusive Distribution Rights for FRSW117 Product in Greater China

China Securities Intelligent Finance: Betta Pharmaceuticals(300558) announced on the evening of November 2 that, in order to further expand its new drug innovation technology platform and enrich its product pipeline layout, the company has reached a strategic cooperation with Jiangsu Shengsi Biopharmaceutical Co., Ltd. and Hangzhou Shengsi Biopharmaceutical Co., Ltd. (the latter two are collectively referred to as “Shengsi Biopharmaceutical”). Betta Pharmaceuticals will support Shengsi Biopharmaceutical in R&D, clinical trials, production, registration and sales promotion, and promote the R&D and commercialization of related products. On the same day, the company’s wholly-owned subsidiary, Zhejiang Beta Pharmaceutical Sales Co., Ltd., signed a “Commercial Cooperation Agreement” with Hangzhou Shengsi Biotechnology, and was granted the exclusive distribution rights for FRSW117 products in the Greater China region. According to the announcement, the target product FRSW117 is a therapeutic biological product.Class 1, intended for routine prophylaxis, on-demand treatment, and perioperative bleeding management in patients with hemophilia A, with prophylactic treatment ...
- Source: drugdu
- 87
- November 3, 2025
Reached a project cooperation agreement with Neurocrine

On November 3, Yaojie Ankang announced on the Hong Kong Stock Exchange that Neurocrine Biosciences, Inc. ( NASDAQ: 00000)NBIX (“Neurocrine”) has entered into a patent transfer and research collaboration agreement with the Company for the payment of royalties in order to develop NLRP3 inhibitors for the treatment of a variety of diseases. Under the agreement, Neurocrine is granted exclusive rights outside Greater China to develop, manufacture, and commercialize its NLRP3 inhibitors from the Genecast NLRP3 drug platform, while the Company retains the rights to develop, manufacture, and commercialize NLRP3 inhibitors within Greater China. The Company will be entitled to an upfront payment under the agreement, and may receive further milestone payments related to R&D and sales milestones as Neurocrine’s development and commercialization progress. The total potential value of the agreement is US$881.5 million. The agreement further covers research collaboration between the parties to further develop NLRP3-related technologies. Source: https://finance.eastmoney.com/a/202511033552850633.html
- Source: drugdu
- 80
- November 3, 2025
【EXPERT Q&A】What key matters should be focused on when upgrading the quality system of in vitro diagnostic (IVDR) in the European Union?

Drugdu.com expert’s response: When upgrading the quality system under the EU In Vitro Diagnostic Medical Device Regulation (IVDR), the following key aspects require particular attention: I. Regulatory Understanding and Compliance In-depth Understanding of IVDR Regulations: The IVDR imposes stricter and more specific requirements on the quality management system for in vitro diagnostic devices, covering aspects such as product classification, technical documentation, performance evaluation, and post-market surveillance. Manufacturers must thoroughly comprehend the regulatory content to ensure their quality systems align with these requirements. Ensuring Compliance Strategies: Manufacturers should develop compliance assessment procedures to clarify the compliance of significant changes to devices covered by the system, determine applicable General Safety and Performance Requirements (GSPR), and explore processes that meet these requirements. II. Establishment and Optimization of the Quality Management System Building a Quality Management System Based on ISO 13485: Although IVDR does not directly mandate ISO 13485 certification, its quality management system ...
- Source: drugdu
- 80
- November 3, 2025
Novartis transferred the exclusive import, commercial promotion, and distribution rights in China for two ophthalmic drugs to Kangzhe Pharmaceutical.

　　On October 27, Jiemian News learned from Novartis that Novartis and Kangzhe Pharmaceutical’s wholly-owned subsidiary, Kangzhe Weisheng, officially signed a strategic cooperation agreement. Effective November 1, 2025, Novartis will transfer the exclusive import, commercial promotion, and distribution rights in China for two of its ophthalmic products, NoxD (ranibizumab injection) and Beyotime (buxizumab injection), to Kangzhe Weisheng for a period of five years. 　　Novartis stated that this strategic agreement signifies a further step in implementing its global “focus” strategy, concentrating on four core therapeutic areas—cardiovascular, renal and metabolic, oncology, and immunology and neuroscience—to more efficiently integrate resources and provide patients with innovative medicines with high clinical value.thing. https://finance.eastmoney.com/a/202510273545245535.html
- Source: drugdu
- 110
- November 2, 2025
Breakthrough in Innovative Drug Development – Hepatitis B siRNA Therapy HECN30227 Approved for Clinical Trials

　China Securities Journal (Wang Luo) – Recently, information released by the National Medical Products Administration (NMPA) shows that Dongyangguang Pharmaceutical ‘s independently developed Class 1 new drug, small interfering RNA (siRNA) HECN30227 injection, has been approved for clinical research in the treatment of chronic hepatitis B. This is another significant advancement in nucleic acid drug development in China’s biopharmaceutical field, marking a significant step forward for domestic companies in innovative drug development.The development of the track continues to accelerate. 　　In recent years, guided by policies and driven by the market, China’s biopharmaceutical industry has gradually built a complete ecosystem covering basic research, clinical translation, and industrialization. HECN30227, which has now been approved, is a product of Dongyangguang Pharmaceutical based on its independent intellectual property rights.The development of the innovative small interfering RNA (siRNA) drug demonstrates China’s research strength and technological accumulation in the field of nucleic acid drugs. This drug participates in the regulation of the ...
- Source: drugdu
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- November 2, 2025
ALK-N001/QHL-1618 for injection received the drug clinical trial approval notice in April 2025.

　　SecuritiesDaily News Network – AnglikangOn October 30, the company issued an announcement stating that, in response to inquiries from researchers, it received approval for clinical trials of its injectable ALK-N001/QHL-1618 in April 2025. As of now, it is in the dose escalation phase of Phase I clinical trials, and the research and development process is progressing according to the original plan. Regarding the ALK-N002/IMD-1005 project, Yafei Bio and Affinity are still carrying out internal approval procedures. Once the approval is completed, the company will fulfill its information disclosure obligations in a timely manner. https://finance.eastmoney.com/a/202510303550388416.html
- Source: drugdu
- 101
- November 1, 2025
The world’s first EGFR ADC drug, MRG003, developed by Lepu Biopharma, has been approved for marketing.

Shanghai Securities News China Securities(Reporter Zhang Xue) According to the official website of the National Medical Products Administration (NMPA), on October 30, Lepu Biopharma’s MRG003 (verbicotutomab) received conditional approval for marketing, for the treatment of patients with recurrent/metastatic nasopharyngeal carcinoma who have failed at least two lines of systemic chemotherapy and PD-1/PD-L1 inhibitor therapy. The brand name is Meiyouheng. This indication had previously been included in the priority review list by the NMPA’s Center for Drug Evaluation. 　　Data shows that MRG003 is the world’s first approved EGFR (epidermal growth factor receptor) ADC (antibody-drug conjugate) drug, marking another newmonument. 　　This drug is composed of a humanized EGFR monoclonal antibody and a potent microtubule-inhibiting payload—methylaurestatin E (MMAE)—conjugated via a valine-citrulline linker. It binds specifically and with high affinity to EGFR on the surface of tumor cells, releasing the potent payload through endocytosis and lysosomal protease cleavage, thereby leading to tumor cell death. EGFR is ...
- Source: drugdu
- 162
- November 1, 2025
Zhifei Biological Products delivers its worst third-quarter report in ten years

Zhifei BiologicalIt delivered its worst third-quarter report in the past decade. 　　According to its third-quarter report, in the first three quarters of 2025, Zhifei Biological Products achieved revenue of 7.627 billion yuan, a year-on-year decrease of 66.53%, and net profit of -1.206 billion yuan, a year-on-year decrease of 156.86%. 　　The reason for the poor performance is straightforward—market sales fell short of expectations. On October 30th, Jiemian News sent an interview request to Zhifei Biological Products Co., Ltd. , but had not received a response by the time of publication. 　　In the first three quarters of 2025, Zhifei Biological’s accounts receivable and inventory remained high. During the period, these two figures were RMB 12.814 billion and RMB 20.246 billion, respectively, accounting for 27.62% and 43.64% of total assets. 　　High accounts receivable indicate that Zhifei Biological Products Co., Ltd. has not been able to receive payments from ...
- Source: drugdu
- 137
- October 31, 2025

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