On March 3, the Drug Clinical Trial Registration and Information Publication Platform showed that Henson Pharmaceuticals initiated the first Phase III clinical trial of HS-20089 (GSK5733584). This is the first B7-H4 ADC drug to enter Phase III clinical stage. The study is a multicenter, randomized, open, positive drug-controlled clinical trial (n=468) designed to evaluate HS-20089 against investigator-selected chemotherapy (topotec...

Today, Genentech, a Roche company, announced that a detailed analysis of REGENCY, a Phase 3 clinical trial of the anti-CD20 antibody therapy Gazyva (obinutuzumab) for the treatment of patients with active lupus nephritis, has been published in the New England Journal of Medicine. The data showed that Gazyva, in combination with standard therapy, met the trial's primary endpoint, significantly improving patients' complete renal remission...

On February 6, Bristol-Myers Squibb (BMS) revealed its decision to terminate the development of Cendakimab, an IL-13 monoclonal antibody that has entered Phase III, during the release of its 2024 results.Cendakimab is no longer visible in the PPT of BMS's 2024 annual report. In response, Adam Lenkowsky, Chief Commercial Officer of BMS, explained, "Given the available data, we have decided to abandon the development of Cendakim...

On February 7, 2025, Novo Nordisk announced updated data from FRONTIER3, a Phase III clinical trial of the FIX/FX dual antibody Min8 for the treatment of childhood hemophilia A. The study was divided into two parts, with the first part receiving 26 weeks of weekly treatment and the second part, the remaining 26 weeks being switched to once-monthly or maintenance weekly treatment. For the first part, the mean annualized bleeding rate (ABR) was 0.53, with a median ABR of 0. 45...

On February 6, 2025, Merck Sharp & Dohme announced the initiation of a pivotal Phase III clinical trial of the new ROR1 ADC drug Zilovertamab Vedotin in combination with R-CHP against R-CHOP for the first-line treatment of diffuse large B-cell lymphoma (DLBCL). WaveLINE-010 is planned to enroll 1,046 patients with DLBCL, with the primary endpoint being PFS and secondary endpoints including CR rate, OS, EFS, C...

SpringWorks Therapeutics, Inc. announced yesterday that the U.S. FDA has approved the marketing of the MEK inhibitor Gomekli (mirdametinib) for the treatment of adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) who are no less than 2 years of age. Their tumors cannot be completely removed. The press release noted that mirdametinib is the first drug approved to...

On February 10, 2025, Boehringer Ingelheim announced that FIBRONEER-ILD, the second Phase III clinical FIBRONEER-ILD for the treatment of idiopathic pulmonary fibrosis with the PDE4B inhibitor Nerandomilast, has met its primary endpoint and will be submitted for marketing. Last September, Nerandomilast's first Phase III clinical FIBRONEER-IPF was successful. Idiopathic pulmonary fibrosis (IPF) is the most common class of progressive...

Index No. JGXX-2025-118 Subject Classification Regulatory Information / Ordered Recall Information Title Beckman Coulter (U.S.A.) Inc Beckman Coulter, Inc. is voluntarily recalling its fully automated chemiluminescent immunoassay analyzer Issue Date 2025-02-25 Beckman Coulter Trading (China) Co. Ltd. is reporting that due to the product's Z-axis pallet clamping motor A forced stop resulted in a c...

Index No. JGXX-2025-114 Subject Classification Regulatory Information / Ordered Recall Information Title Medtronic, Inc. initiated a voluntary recall of single-use intracardiac diagnostic electrode catheters Release Date 2025-02-25 Medtronic (Shanghai) Management Co. Ltd. has reported that due to the presence of an incorrect model number and batch number on the product's outer box labeling, the manufacturer, Medtronic, Inc. Medtronic, I...

[2/21/2025] FDA has determined the shortage of semaglutide injection products, a glucagon-like peptide 1 (GLP-1) medication, ...

[10/30/2024] FDA is warning consumers to not purchase or use Skin-Cap aerosol spray products because they may contain undisclosed steroids. this ...

[11/1/2024] FDA is warning patients and health care professionals not to use drugs compounded and distributed by Fullerton Wellness LLC, Ontario, ... ...

[1/16/2025] FDA is warning health care professionals not to use unapproved epinephrine nasal solutions manufactured by BPI Labs LL...

[9/18/2024] FDA is warning consumers and health care professionals not to use SnoreStop Nasal Spray, distributed by Green Pharmaceuticals Inc. ...

Index No. JGXX-2025-117 Subject Classification Regulatory Information / Ordered Recall Information Title Oridion Medical 1987 Ltd. is voluntarily recalling micro-bypass end-expiratory carbon dioxide monitoring sampling tubes Release Date 2025-02-25 Kewe Medical Devices International Trading (Shanghai) Co. Ltd. is reporting that, due to the sampling tubes being removed from the patient's tracheal intubation...

Regulations on the Supervision and Administration of Medical Devices (January 4, 2000, the State Council of the People's Republic of China Decree No. 276 published February 12, 2014, the State Council 39th executive meeting revised and adopted according to the May 4, 2017 "the State Council on the revision of the" Regulations on the Supervision and Administration of Medical Devices "decision" the first revised December 21, 2020, the State Council No. 1 ...

Description: The State Drug Administration (SDA) released a document on January 15, 2025 on its official website to publicly solicit comments and suggestions on the Draft Revised Code of Practice for the Quality Management of Medical Device Manufacturing (Draft Revision for Comment). In order to facilitate the regulatory authorities and enterprises to understand the main points of the draft revision and the 2014 version of the "Code for Quality Management of Medical Device Manufacturing", the State Drug Administration (SDA) published a document on its official website on January 15, 2025 to solicit comments and suggestions from the public.

Index No. FGWJ-2025-121 Subject Classification Regulatory Documents / Normative Documents Title Notification of the Comprehensive Department of the State Drug Administration on the Project of Medical Device Industry Standard for "Medical Devices Adopting Brain-Computer Interfaces Quality Requirements and Evaluation Methods of Electroencephalography Datasets Used for Artificial Intelligence Algorithms" Date of Issue: 2025-02-25 CIRC: In order to satisfy the urgent need for supervision and to help promote In order to meet the urgent regulatory needs and to help promote the ...

Index No. FGWJ-2025-117 Subject Classification Regulatory Documents / Normative Documents Title Report on Medical Device Registration Work in FY 2024 Issue Date 2025-02-13 In FY 2024, the State Drug Administration, guided by Xi Jinping's Thought on Socialism with Chinese Characteristics in the New Era, comprehensively carried out the spirit of the 20th National Congress of the Party, and the Second and Third Plenary Sessions of the 20th CPC Central Committee, and followed the principle of "political, strong supervision, safety, development and development". "Speaking Politics, Strengthening Supervision, Ensuring Safety, Promoting Development and Benefiting the People's Life"...

Index No. FGWJ-2024-138 Subject Classification Title Interpretation of the Notice on Standardizing the Work of Classifying and Defining Medical Device Products Issue Date 2024-05-11 In order to further standardize the work of classifying and defining medical device products, combined with the actual situation of classifying and defining medical device products in our country, the State Drug Administration (SDA) has organized the revision of the former General Office of the Food and Drug Administration (GODA) "Notice on Standardizing the Work of Classifying Medical Device Products" (Food... Classification of Medical Device Products" (Food and Drug...

　　For the implementation of the "supervision and management of medical devices regulations", the full implementation of medical device registrants (hereinafter referred to as the registrant) quality and safety of the main responsibility to further strengthen the registrant entrusted to the supervision and management of the production, and effectively prevent and control the risk of medical device quality and safety. Now on the relevant matters announced as follows: First, the strict implementation of the main responsibility of medical device registrants (a) registrants should fully implement the main responsibility for the quality and safety of medical devices, the establishment of a...

　　In 2024, the State Drug Administration adhered to Xi Jinping's thought of socialism with Chinese characteristics in the new era as a guide, fully implemented the 20th CPC National Congress and the spirit of the 2nd and 3rd Plenary Sessions of the 20th CPC Central Committee, implemented the requirements of the "four most stringent", in accordance with the work idea of "political, strong supervision, safety, development and people's livelihood. In accordance with the working idea of "speaking politics, strengthening supervision, ensuring safety, promoting development and benefiting people's life", integrating high-quality development and high-level safety, the standardization work of medical devices has stepped up to a new level, and the high standard has helped the scientific supervision of medical devices, promoted technological innovation, and led to the...