Since the beginning of 2024, three innovative drugs have been approved for marketing.
On January 9, the State Food and Drug Administration announced the approval of the traditional Chinese medicine 1 declared by Qijin PharmaceuticalClass 1 innovative drug catechu supernatant pill was launched for mild ** aphthous ulcer on coke and heat syndrome. On the same day, Eisai's lencanemab injection was approved by the NMPA for the treatment of mild cognitive impairment caused by Alzheimer's disease and mild dementia due to Alzheimer's disease. On January 10, Eli Lilly announced that gacanelizumab injection was officially approved by the State Food and Drug Administration for the prophylaxis of migraine.
In recent years, China's pharmaceutical companies have strengthened the research and development of new drugs, and the review and approval process of innovative drugs has been accelerated. According to statistics, a total of 40 innovative drugs will be approved for marketing in 2023, exceeding the number of innovative drugs that have been reviewed and approved by 21 in 2022.
Among the innovative drugs that have been reviewed and approved in 2023, there are 35 local innovative drugs and 5 imported drugs. At the same time, the approval channel for the listing of innovative drugs in China is smoother, and the number of innovative drugs that have been approved for priority review and special approval and listing in 2023 will be 7 and 4 respectively.
In terms of drug types, there were 19 innovative chemical drugs, 13 innovative biological drugs, 5 proprietary Chinese medicines and natural medicines, and 3 diagnostic tools. **In terms of fields, continuing the trend of new drugs in recent years, the number of anti-tumor drugs approved is the largest, accounting for more than 35%.
It is worth mentioning that in the field of anti-oncology, there are a number of innovative drugs whose marketing applications have been accepted or will be approved in 2024, covering bispecific antibodies, ADCs, small molecule tyrosine kinase inhibitors, KRAS-G12C inhibitors and other popular drug types.
Among the bispecific antibody varieties, the marketing applications of Akeso's ivoximab and Johnson & Johnson terituzumab were accepted in August 2023, and both of them have obtained priority review qualifications. The proposed indication for ivoximab is the combination of pemetrexed and carboplatin in locally advanced or metastatic non-squamous non-small cell lung cancer with EGFR mutations that have progressed after an EGFR tyrosine kinase inhibitor**. Teritumab is intended for use in patients with multiple myeloma who have received at least three prior treatments, including a proteasome inhibitor, an immunomodulator, and an anti-CD38 monoclonal antibody. ** in the industry, the two drugs are expected to be approved for marketing in Q3 2024.
Among the ADC varieties, the marketing application of Tellantuximab for injection was accepted in July 2023 and has been qualified for priority review, and the application indication is monotherapy*** refractory diffuse large B-cell lymphoma. The industry expects its approval to be in Q3 2024.
Huadong Medicine's marketing application for somituximab was accepted in October 2023 and has been granted priority review for the proposed indication of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have previously received 1-3 system** folate receptor (FR)-positive folate receptor (FR). Huadong Medicine said the product is expected to be approved for marketing in 2024.
In May 2023, the marketing application of HER2 ADC A166 was accepted for the indication of HER2-positive unresectable locally advanced, ** or metastatic breast cancer with prior failure of second-line or above anti-HER2**. Previously, Columbotai had said that it expects to launch the commercialization of core products such as A166 in the Chinese market in the second half of 2024 or the first half of 2025.
Edited by Zhou Tong.
Synthesized from the State Food and Drug Administration, enterprise announcements, Shenzhen Stock Exchange Interactive Easy, Insight database, etc.).