Weekly Pharmaceutical Highlights (March 2–8): Regulatory Updates and Product Approvals

(Source: China Food and Drug Administration Network)

The General Office of the National Medical Products Administration issued a notice to arrange for studying, publicizing, and implementing the newly revised "Regulations for the Implementation of the Drug Administration Law of the People's Republic of China" (hereinafter referred to as the "Regulations"); the "Technical Guidelines for Clinical Trials of Drugs for the Treatment of Chronic Rhinosinusitis with Nasal Polyps" and the "Considerations for Subject Population Selection in Bioequivalence and Pharmacokinetic Comparative Studies of Anticancer Drugs" were released... The dynamics of the pharmaceutical industry from March 2nd to 8th are worth noting.

Industry Policies and Drug Regulatory Dynamics

1. The General Office of the National Medical Products Administration issued a notice to arrange for the study, publicity, and implementation of the newly revised Regulations. The notice requires that all units fully recognize the importance of studying, publicizing, and implementing the Regulations; deeply study and understand the legislative spirit and key contents of the Regulations; accelerate the formulation and revision of supporting documents to ensure effective implementation; innovate methods and actively carry out publicity and training; consolidate the foundation of supervision, and strengthen the construction of the regulatory system and regulatory capacity.

2. The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) released the "Technical Guiding Principles for Clinical Trials of Drugs for the Treatment of Chronic Rhinosinusitis with Nasal Polyps," aiming to guide the scientific research and evaluation of drugs for the treatment of chronic rhinosinusitis with nasal polyps, providing a referenceable technical standard. The guiding principles mainly address key issues in the clinical development and confirmatory clinical trials of innovative drugs for the treatment of chronic rhinosinusitis with nasal polyps, such as pharmacokinetic requirements, inclusion and exclusion criteria for subjects, selection of controls, medication cycles, efficacy endpoints, and safety evaluations, but do not cover the development of innovative glucocorticoid drugs for the treatment of chronic rhinosinusitis with nasal polyps.

3. CDE Releases "Considerations for Selecting Subject Populations in Bioequivalence and Pharmacokinetic Comparative Studies of Anticancer Drugs." The guideline primarily draws on research experience with small-molecule chemical drugs and monoclonal antibody drugs, providing recommendations for considerations in selecting subject populations for bioequivalence and pharmacokinetic comparative studies of anticancer drugs.

4. CDE Opens Public Consultation on the "Technical Guidelines for Clinical Trials of Preventive mRNA Vaccines (Draft for Comments)". The draft introduces the definition and characteristics of mRNA vaccines, first presenting general considerations regarding target diseases, target populations, safety monitoring, and platform technology, then elaborating on the design and evaluation of clinical trials, and finally clarifying key points related to post-marketing research and platform technology.

5. The CDE website announced four generic drug quality and efficacy consistency evaluation tasks (see table for details), involving varieties such as Cefoperazone Sodium and Sulbactam Sodium for Injection.

Product R&D and Market Launch Information

1. The National Medical Products Administration released the fifth batch of drug approval certificates delivery information, covering a total of 284 application numbers, involving companies such as YuanDa Shuyang Life Science (Chengdu) Co., Ltd.

2. CDE accepted 67 new drug marketing applications, including Lyophilized Oral Rotavirus Attenuated Live Vaccine (Vero Cells), etc.

3. Sinotherapeutics Inc. announced that the Abbreviated New Drug Application (ANDA) for its Vitamin K1 Tablets has been officially approved by the U.S. Food and Drug Administration (FDA).

4. Drug Farm announces that the company's experimental therapy DF-003 for ROSAH syndrome has been included in the US FDA Rare Disease Evidence Principle (RDEP) certification.

5. Ruichu Pharmaceuticals announced that RC017, an innovative drug developed by the company targeting aging mechanisms for the treatment of eye diseases, has received approval from the U.S. FDA for a new drug clinical trial.

6. Sinopharm Group announced that the IND application for SYH2059 Inhalation Powder developed by the group has been approved by the U.S. FDA. The drug's approved clinical trial indications this time are for pulmonary fibrosis, including idiopathic pulmonary fibrosis and progressive pulmonary fibrosis.

7. Tong Ren Tang announced that the product Yougui Pills from its branch Tong Ren Tang Pharmaceutical Factory has obtained Canadian product registration approval.

Observation of Pharmaceutical Enterprises

1. Antengene Announces Global Exclusive Licensing Agreement with UCB. According to the agreement, Antengene grants UCB exclusive global rights to develop, manufacture, and commercialize ATG-201, a CD19/CD3 bispecific T-cell engager antibody, including related manufacturing technology licenses for ATG-201. Antengene will receive an upfront payment and near-term milestone payments totaling $80 million and is eligible to receive over $1.1 billion in milestone payments and tiered royalties based on future net sales.

2. Insilico Medicine announced the signing of a strategic cooperation agreement with the UAE Drug Administration. The two parties will work together to promote the pharmaceutical industry development in the UAE through cutting-edge technologies such as AI-empowered drug discovery and development.

3. Starset Bioannounces a strategic cooperation with Kactus Bio. According to the cooperation agreement, Starset Bio grants Kactus Bio the global production and sales rights for related products. Both parties will integrate Starset Bio's original innovation capability in underlying gene editing technology with Kactus Bio’s industrial experience in large-scale production of raw material enzymes, quality systems, and global commercial promotion, jointly advancing the industrialization process and commercial application of new gene editing technologies.

4. Keluosi Biotech announced that it has signed a strategic cooperation agreement with Tongyi Pharmaceuticals. According to the agreement, the two parties will carry out systematic cooperation in three major areas: First, they will focus on the joint development and sharing of results for innovative pipelines with differentiated competitiveness; Second, they will integrate their R&D and business development resources to jointly promote the global commercialization of key projects; Third, they will explore diversified cooperation mechanisms at the capital level, driving the coordinated development of industry and capital to enhance overall strategic efficiency and value creation capabilities.

5. China Biologic Products announced that it has reached an exclusive licensing agreement with Sanofi for the JAK/ROCK inhibitor Rovatistinib. According to the agreement, China Biologic Products' subsidiary Chia Tai Tianqing grants Sanofi the exclusive rights to develop, manufacture, and commercialize Rovatistinib globally. China Biologic Products is entitled to receive up to $1.53 billion in payments, including a $135 million upfront payment and subsequent potential development, regulatory, and sales milestone payments. Additionally, China Biologic Products can collect tiered royalties of up to double-digit percentages based on Rovatistinib's annual net sales.

Centralized Drug Procurement

1. The Centralized Procurement Center for Medical Drugs and Devices of Hebei Province issued a notice stating that it plans to carry out the renewal of centralized procurement for some drugs whose alliance (provincial) procurement has expired, including eight varieties such as Ferrous Succinate Protein. Public medical institutions at all levels in Hebei Province, military medical institutions, and designated pharmacies for outpatient services are the main entities responsible for this round of drug procurement. The selected drugs from this procurement will take effect from the execution date, with a procurement cycle of two years, and the procurement agreement will be signed annually during the cycle.

2. The three departments of Jiangxi Province's Medical Insurance Bureau, Provincial Health Commission, and Provincial Drug Administration jointly issued the "Notice on Further Standardizing the Unified Procurement of Medicines and Medical Consumables in Close-County Medical Consortiums." The notice specifies that the medical consortium must meet the evaluation standards for close-type medical consortium construction and have implemented total "package" payment management for medical insurance funds. The general hospital or lead hospital of the medical consortium is responsible for the unified procurement of medicines and medical consumables, overseeing the procurement, distribution, settlement, traceability, and adjustment of all member units within the consortium. Additionally, the medical consortium follows the "Ten Unifications" principle (unified account, unified catalog, unified demand, unified procurement, unified distribution, unified settlement, unified traceability, unified adjustment, unified assessment, and unified information) to standardize the procurement process for medicines and medical consumables.

3. Shanghai Medical Centralized Bidding Procurement Management Office Releases "Notice on Further Improving the Price Risk Warning Labels for Listed Drugs in the City". The notice clarifies that biologics (biological products + biosimilars) will be merged and classified, with risk labels adjusted as follows: Yellow label price set at three times the lowest listed price of the same type of drug, and red tag price set at five times the lowest listed price. In addition, starting from the fourth quarter of this year, the procurement behavior of medical institutions will be monitored quarterly, with related results incorporated into the assessment scope of medical institutions. Particular attention will be paid to medical institutions where the proportion of procurement amount of "red label" drugs exceeds 10%, or the cumulative procurement amount of "red and yellow label" drugs exceeds 25%. (Organized by Liu He)

China Pharmaceutical News Copyright, no reprinting or use without permission.

(Editor: Liu Sihui)