China Accelerates Drug Review Process with 142 Innovative Drugs Approved for Market

　　【Pharmaceutical Network Industry DynamicsIn recent years, the efficiency of China's drug review and approval process has continued to improve, and with this ongoing enhancement, the speed at which innovative drugs are approved for marketing has also been constantly accelerating.
 

According to relevant sources, the average drug approval time has been reduced from 16 months in 2017 to 12 months, and the completion rate of reviews within the statutory time limit has increased from 15.1% to 98.8% in the first half of this year. In addition, up to now, a total of 142 innovative drugs have been approved.
 

According to the review, multiple innovative drugs have been approved for marketing since November 2023. For instance, on November 17, the National Medical Products Administration announced that JUMPCAN PHARMACEUTICAL GROUP CO.,LTD's application for the improved traditional Chinese medicine of category 2.2, Xiao'er Chiqiao Qingre Syrup, has been approved for marketing. This medicine disperses wind and relieves exterior symptoms, clears heat, and removes stagnation. It is used for pediatric wind-heat colds with symptoms such as fever, cough, nasal congestion, runny nose, redness and swelling of the throat, poor appetite, thirst, fullness in the stomach and abdomen, constipation or foul-smelling stools, and yellow urine.
 

According to a message released on November 16 by the National Medical Products Administration, the Class 1 innovative drug Berotinib Enteric-Coated Capsules, submitted by Beijing Purun'ao Biotechnology Co., Ltd., has been approved for marketing. This medication is suitable for treating patients with locally advanced or metastatic non-small cell lung cancer harboring mesenchymal-epithelial transition factor (MET) exon 14 skipping mutations. Data shows that Berotinib is a cell-mesenchymal-epithelial transition factor (c-MET) receptor tyrosine kinase inhibitor that can suppress the proliferation of tumor cells with high c-MET expression.
 

According to a message from the National Medical Products Administration on November 14, the innovative natural drug 1.1 class Xiang Lei Tang Foot Ointment applied by ONENESS has been approved for marketing. It is used for Wagner Grade 1 diabetic foot ulcers with a wound area less than 25cm² after debridement.
 

According to the news from the National Medical Products Administration on November 8, the Nirocabin Injection (trade name: Yuanruida) submitted by Juventas and the Glofitamab Injection (trade name: Gao Luohua/Columvi) submitted by Roche Pharma (Schweiz) AG have been conditionally approved for marketing through the priority review and approval process.
 

Among them, Naciorlucel Injection is an autologous T-cell immunotherapy product prepared by using gene modification technology to express a chimeric antigen receptor (CAR) targeting CD19 on the surface of T cells. After infusion into the body, it binds to target cells expressing CD19, activates downstream signaling pathways, induces the activation and proliferation of CAR-T cells, and produces a cytotoxic effect on the target cells. This drug is used to treat adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
 

According to a November 2 announcement by the National Medical Products Administration, the injectable drug Epronelim (brand name: Shaite) submitted by Wuhan Hiteck Biological Pharma Co., Ltd. has been approved for marketing. This medication, in combination with thalidomide and dexamethasone, is used for adult patients with relapsed or refractory multiple myeloma who have previously received at least two systemic treatment regimens.
 

Experts in the industry indicate that in recent years, China's pharmaceuticals industry has expedited innovation and development, with overall standards reaching a new level. To date, China has over 10,000 large-scale pharmaceutical enterprises, with their added value accounting for approximately 4% of the total industrial added value. Meanwhile, a large number of innovative drugs, key vaccines, traditional Chinese medicine compound preparations, and high-end medical devices have been approved for marketing, significantly enhancing supply and security capabilities, effectively meeting people’s health needs.
 

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