April 29, 2025
Source: drugdu
72
NO.1 clarifies for the first time to crack down on online "medical trusts"
The National Center for Disease Control and Prevention and three other departments recently jointly released the "2025 National Random Supervision and Sampling Plan" for the medical and health field. Compared with the 2024 plan, the 2025 plan will make adjustments in the scope of supervision, add new areas of supervision such as Internet diagnosis and treatment, mental health, and for the first time explicitly crack down on new illegal behaviors such as online "medical care", further strengthen the governance of public health and medical order.
Comment: The clear crackdown on online "medical trusts" in regulation is a powerful upgrade to medical supervision. The concealment of online "medical care" is strong, seriously disrupting medical order and damaging patient rights. It is expected to purify the medical network space with the supervision of new fields such as Internet diagnosis and treatment.
NO.2 Xinda Biotechnology announces the approval of the first-line indication for the third-generation EGFR TKI lung cancer targeted drug, which is in cooperation with Oseikon
Xinda Biotechnology announces the third representative skin growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) targeted drug Aoyi Xin ® The New Drug Administration (NMPA) has approved the New Drug Application (NDA) for Lirotinib tablets for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients with epidermal growth factor receptor (EGFR) exon 19 deletion (19DEL) or exon 21 replacement mutation (L858R).
Comment: Aoyi Xin ® Lirotinib tablets are currently the only third-generation EGFR-TKI drug approved for market, based on the naphthylamine structure. The approval of first-line indications not only brings new choices for the treatment of EGFR mutation positive NSCLC patients, but also marks the successful expansion of the indications for liraglutide from the posterior line to first-line patients, and the clinical applicable patient population continues to expand.
NO.3 Xianju Pharmaceutical is expected to be fined 195 million yuan for suspected monopoly. Tianjin Market Supervision Commission: The case is still in the processing stage
Xianju Pharmaceutical disclosed in its 2024 annual report that it received an administrative penalty notice in April 2025, alleging that the company had reached a monopoly and implemented a monopoly agreement to fix and change the price of dexamethasone sodium phosphate raw materials. The company is expected to be fined approximately 200 million yuan.
A reporter from the Daily Economic News called the Tianjin Market Supervision Commission, and the staff said that the case is still in the processing stage and no formal decision has been made yet. A notification letter has been delivered to the enterprise.
Comment: From a market perspective, monopolistic prices of active pharmaceutical ingredients can disrupt the normal order of the pharmaceutical market and affect the production and operation of other pharmaceutical companies. From the perspective of industry development, this incident highlights the regulatory authorities' high attention to anti-monopoly in the pharmaceutical industry. However, the case is still in the processing stage, and the specific situation is still pending disclosure of the final outcome.
NO.4 Pfizer Innovent and Junshi Biologics PD-1 monoclonal antibody approved as first-line target immunotherapy combination therapy
On April 25th, Pfizer announced its oral targeted drug, Infliximab ® (generic name: Axitinib tablets) was approved by the National Medical Products Administration (NMPA) on April 22, 2025, for first-line treatment of medium to high risk unresectable or metastatic renal cell carcinoma (RCC) patients in combination with trastuzumab.
Comment: Previously in China, targeted drugs were the main treatment strategy, and patients' survival still faced severe challenges. The combination of Axitinib and Terriptylimab has been approved for first-line treatment of advanced renal cell carcinoma, which is the first and only approved first-line target free combination therapy in the field of renal cancer treatment in China, marking the entry of China's advanced renal cancer treatment into the era of target free combination therapy.
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