China's NMPA Proposes Up to ¥1M Whistleblower Rewards; Bi Jingquan Warns Against 'One-Time' Generic Drug Evaluations
Juventas
Innovative Cell Therapy Drug Developer
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Author | Huang Kai
New Developments in Pharmaceutical Regulation.
On October 10, the National Medical Products Administration released the "Announcement on Rewarding Internal Whistleblowers for Reporting Drug and Medical Device Quality and Safety Violations (Draft for Public Comment)" to further enhance internal oversight within the drug and medical device supply chains and promptly identify and control safety risks related to drugs and medical devices.
The key points of this draft for public comment that have attracted widespread attention in the industry are: first, the reward of one million yuan; second, the mention of internal whistleblowers in the announcement, including internal employees and other relevant informants.
Bi Jingquan's Latest Speech.
On October 11, Bi Jingquan published an article on the official account, stating that to promote the high-quality development of the generic drug industry and strengthen confidence in domestically produced generics, it is essential to prevent the consistency evaluation from becoming a "one-time evaluation." This requires enhancing public awareness of scientific knowledge, strengthening supervision of the production process, ensuring reasonable profits for products selected through centralized procurement, and effectively addressing regional conflicts of interest.
In the past day, what hot topics in the pharmaceutical market at home and abroad are worth paying attention to? Let Amino take you to explore.
/ 01 /
Market Express
1) "Compliance Guidelines for Pharmaceutical Enterprises to Prevent Commercial Bribery Risks" Open for Public Comment
On October 11, the State Administration for Market Regulation drafted the "Compliance Guidelines for Pharmaceutical Enterprises to Prevent Commercial Bribery Risks (Draft for Public Comment)" and is now soliciting public opinions.
2) Bi Jingquan: Prevent the Consistency Evaluation from Becoming a "One-time Evaluation"
On October 11, Bi Jingquan published an article on the official account stating that to promote the high-quality development of the generic drug industry and strengthen confidence in domestically produced generics, it is essential to prevent the consistency evaluation from becoming a "one-time evaluation." This requires enhancing public awareness of scientific knowledge, strengthening supervision of the production process, ensuring reasonable profits for products selected through centralized procurement, and effectively preventing conflicts of local interests.
3) NMPA Offers Up to a Million Yuan Reward for Internal Whistleblowers
On October 10, the National Medical Products Administration released the "Announcement on Implementing Rewards for Internal Whistleblowers Reporting Drug and Medical Device Quality and Safety (Draft for Comments)" to further leverage internal supervision within the drug and medical device supply chains and promptly identify and control safety risks related to drugs and medical devices. The key points of this draft that have drawn widespread attention in the industry are: firstly, the reward of up to a million yuan; secondly, the mention of internal whistleblowers in the announcement, including employees and other relevant informants.
/ 02 /
Capital Information
1) Beijing Tiantan Biological Products Corporation Limited Reports 18.52% Year-on-Year Increase in Net Profit for the First Three Quarters
On October 11, Beijing Tiantan Biological Products Corporation Limited announced its Q1-Q3 2024 earnings report. The company's total operating revenue reached 4.073 billion yuan, representing a year-on-year increase of 1.28%. Net profit attributable to shareholders of the listed company was 1.052 billion yuan, marking an 18.52% year-on-year growth.
/ 03 /
Pharmaceutical News
1) Juventas' Natrium Allogeneic CAR-T Injection Receives Clinical Approval
On October 11, according to the CDE official website, Juventas' Nageo Cell Injection received clinical approval and is planned to be used for treating refractory systemic lupus erythematosus-associated immune thrombocytopenia.
2) Ruifeng Bio's RM-101 Injection Receives Clinical Approval
On October 11, according to the CDE official website, Ruifeng Bio's RM-101 injection received clinical approval for the treatment of Usher syndrome type 2-associated RP or non-syndromic RP caused by mutations in exon 13 of the USH2A gene.
3) Ruihongdi Medical RGL-193 Injection Receives Clinical Approval
On October 11, according to the CDE official website, Ruihongdi Medical's RGL-193 injection received clinical approval and is planned to be studied for the treatment of Parkinson's disease.
4) Yimiao Medical's IM96 CAR-T Cell Injection Receives Clinical Approval
On October 11, according to the CDE website, Yimiao Medical's IM96 CAR-T Cell Injection received clinical approval and is planned to conduct research for the treatment of colorectal cancer.
5) Eukary Biopharmaceuticals GQ1005 Injection Receives Clinical Approval
On October 11, according to the CDE official website, QED Biotech's GQ1005 injection received clinical approval. It is proposed to be used in combination with carboplatin for the treatment of patients with advanced or metastatic non-small cell lung cancer harboring HER2 exon 19 or 20 mutations.
6) Hengrui Medicine's SHR2554 Tablet Granted Priority Review
On October 11, according to the CDE official website, Hengrui Medicine's SHR2554 tablet is proposed for priority review, intended for use in relapsed or refractory peripheral T-cell lymphoma patients who have previously received at least one line of systemic treatment.
/ 04 /
Instrument Tracking
1) New Industry Legionella pneumophila IgM Antibody Detection Kit Obtains Medical Device Registration Certificate
On October 11, New Industry announced that the Legionella pneumophila IgM Antibody Detection Kit (Chemiluminescence Immunoassay) obtained medical device registration.
2) SugarJi Medical Silicone-Coated Esophageal Stent System Obtains Medical Device Registration Certificate
On October 11, according to the NMPA website, Tangji Medical's silicone-coated esophageal stent system obtained a medical device registration certificate.
3) Synapse Medical's Implantable Rechargeable Deep Brain Stimulator Obtains Medical Device Registration Certificate
On October 11, according to the NMPA website, SceneRay's implantable rechargeable deep brain neurostimulator obtained a medical device registration certificate.
/ 05 /
Digital Healthcare Daily
1) JD Health's Guoyi Hall "Zhiye Tang" Beijing First Store Officially Opens
On October 11, the first "Zhiye Tang" JD Health Traditional Chinese Medicine Clinic in Beijing, located at Guorui Plaza in Yizhuang, Beijing, and covering an area of more than 500 square meters, officially opened.
/ 06 /
Overseas Pharmaceutical News
1) Sanofi in Talks to Sell Controlling Stake in Consumer Health Business
On October 11, Sanofi announced that it had entered into negotiations with U.S. private equity firm Clayton, Dubilier & Rice to sell a 50% controlling stake in its consumer health business, Opella. Sanofi did not disclose any financial details of the potential deal and stated that further updates would be provided at the appropriate time.
2) Roche's PI3Kα Inhibitor Approved for Marketing
On October 10, the FDA's official website showed that it had approved Roche's PI3Kα inhibitor inavolisib for marketing. The indication is in combination with palbociclib and fulvestrant for the treatment of adult patients with locally advanced or metastatic breast cancer who are hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, have PIK3CA mutations, and have developed resistance to endocrine therapy during or after adjuvant endocrine therapy.
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