Recently, the leading CRO company in China, WuXi AppTec, released an overview of the highlights of China's innovative drug field in the first half of 2024 (hereinafter referred to as the "Overview"), which sorted out the highlights of China's innovative drug field in the first half of 2024.

According to the Overview, significant achievements were made in the field of new drugs in the first half of 2024: a total of 44 new drugs were approved for the first time in China, including 23 Class 1 innovative drugs; 26 new drug marketing applications have been included in the priority review by CDE; 41 new drug projects have been officially included in the list of breakthrough treatment varieties; New breakthroughs have also been made in financing and authorization cooperation. In the field of innovative drugs in China, there have been 92 financing events of different rounds and natures, 31 authorization cooperation, and 23 and 18 new drugs developed by Chinese companies have been granted fast track and orphan drug qualifications by the FDA, respectively

1. The number of approved innovative drugs remains high

A total of 44 new drugs (including Class 1 and Class 5.1 chemical drugs; Class 1 and Class 3.1 therapeutic biological products, excluding vaccines) have been approved for the first time in China, including 23 innovative drugs in Class 1; In addition, nearly 50 new drug indications/formulations have been approved in China.

From the perspective of the types of drugs approved for listing, small molecule chemical drugs are still the mainstream, accounting for 59%; Antibody and peptide drugs account for a relatively high proportion in biological products, totaling 32%; From the distribution of new drugs approved for marketing, tumor drugs and type 2 diabetes metabolic drugs account for a high proportion, accounting for half of the number of new drugs approved.

Among the new drugs approved for market by the National Medical Products Administration, there are 23 Class 1 innovative drugs, accounting for 52%. Four of these new drugs are from multinational pharmaceutical companies, including Eisai/Bojian, Novartis, Roche, and Novo Nordisk; The remaining nearly 20 are Chinese companies from Hengrui Pharmaceutical, Hisco, Chia Tai Tianqing, Kangfang Biology, Keji Pharmaceutical, etc., which is the same as that of COVID-19 Pharmaceutical in the first half of 2023. Among them, Zhengda Tianqing is the biggest winner, with three Class 1 new drugs approved for market, while Hisilicon and Zaiding Pharmaceutical each have two new drugs approved for market.

Note: The scope of data statistics includes Class 1 and Class 5.1 of chemical drugs, Class 1 and Class 3.1 of therapeutic biological products. The data is sourced from NMPA and WuXi AppTec's "Overview".

2. Newly added priority evaluation of 26 new drugs, mainly oncology drugs

In the first half of 2024, a total of 26 new drug marketing applications were officially included in the priority review, which is similar to the same period in 2023.

From the perspective of the treatment field of the new drugs included in the priority review, there are 18 new anti-tumor drugs, accounting for 69% of the total, involving HER2 negative breast cancer, multiple myeloma, non-small cell lung cancer, endometrial cancer, MSI-H/dMMR colorectal cancer, diffuse large B-cell lymphoma, plexiform neurofibroma, follicular lymphoma, VHL disease related cancer, etc. The details are as follows:

Note: Derived from CDE, WuXi AppTec's "Overview".

3. Record high number of breakthrough therapy drugs included

In the first half of 2024, 41 new drug projects were announced through CDE and officially included in the list of breakthrough treatment varieties, the highest in the same period of the past four years, compared to only 26 in the first half of 2021.

Note: CDE, WuXi AppTec Overview.

From the perspective of incorporating breakthrough therapy drug types, there is a trend towards diversification in drug types. The number of small molecule drugs is the highest, with 17, accounting for 41.5%; Secondly, there are 10 antibody conjugated drugs (ADCs); There are 8 antibody drugs (including monoclonal antibodies and bispecific antibodies); There are three types of cell and gene therapies. In addition, there are some nucleic acid drugs and peptide drugs.

4. Authorize cooperation and maintain active investment and financing

Authorized cooperation for 31 projects, with nearly half of them going abroad

In the first half of 2024, Chinese companies reached 31 different types of authorized cooperation on innovative drugs, involving 36 drug research and development projects. From the perspective of cooperation types, these collaborations include 15 license out collaborations, 9 license in collaborations, and 7 collaborations between Chinese companies.

From the research and development stage of authorized cooperative drugs, the main focus is on entering the clinical stage, accounting for over 80%. Specifically, drugs in the preclinical stage account for 17%; Drugs in the clinical stage before Phase II accounted for 33%; Drugs in clinical stages II/III accounted for 39%; In addition, there are four drugs that have been approved for marketing.

From the perspective of disease domain of authorized cooperative drugs, these authorized cooperative drugs mainly cover tumor, cardiovascular disease, autoimmune disease, infectious diseases and other indications.

92 investment and financing events, with over 20 involving amounts exceeding 100 million

In the first half of 2024, according to the data on the number of instant drugs cited in the Overview, there were a total of 92 financing events of different rounds and natures in the field of innovative drugs in China.

From the perspective of the disease field, cancer remains a highly concerned area, with 60 financing events and nearly 70% of the total investment and financing events involving this field; Other disease areas with a high number of financing events include central nervous system (22 cases), anti infection (21 cases), rare diseases (16 cases), respiratory system (16 cases), immune system (16 cases), dermatology (16 cases), etc.

In terms of financing amount, 20 companies have financing amounts of over 100 million yuan; Eight companies have financing amounts exceeding 50 million US dollars (over 350 million RMB).

Image caption: sourced from the "Overview" of WuXi AppTec's "Instant Medication Count".

In addition, with the strengthening of China's innovative drug research and development capabilities and the improvement of innovation levels, the number of new drugs recognized by the world's most representative drug approval agency, the FDA, is also increasing.

In the first half of 2024, a total of 23 new drugs developed by Chinese companies were granted fast track qualifications by the FDA, including 20 drugs in the field of oncology; 18 new drugs developed by Chinese companies have been granted orphan drug status by the FDA, and 11 of them have indications related to tumors.

Reprinting link: 44 innovative drugs approved for market (list attached) _ Yaozh News (yaozh. com)

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