At the beginning of the new year, innovative drugs continue to have good news.
As a leading enterprise in the pharmaceutical industry, Hengrui Pharmaceutical has played a very leading role, and in the first week of the new year, Hengrui Pharmaceutical's three innovative drugs have been approved for marketing one after another, adding a lot of impetus to domestic innovative drugs. At the end of January, the company reported good news again: the company's self-developed Tygilidine fumarate injection was approved for marketing, mainly used for moderate to severe pain after abdominal surgery. This is also the first self-developed Class 1 opioid analgesic innovative drug in China.
This is not only the joy of the launch of innovative drugs, but also the joy of the momentum of domestic innovative drugs going overseas. Pharmaceutical companies such as SanReno Pharmaceutical, Anrui Biologics, and Ribo Biosciences announced that they will work together with overseas pharmaceutical giants to bring China's innovative drugs abroad. As a result, 2023 is known as the first year of domestic innovative drugs "going overseas".
Perhaps, 2024 is also expected to be the first year for the sales of innovative drug products.
In 2023, 40 innovative drugs will be approved.
In 2023, the reform of China's drug review and approval system will enter its eighth year. As the impact of the epidemic subsides, the pace of drug review and approval has returned to normal, and domestic innovative drugs have ushered in an unprecedented harvest. A few days ago, the State Food and Drug Administration released the "2023 Drug Evaluation Report" (hereinafter referred to as the "Report") is freshly released!
In 2023, the Drug Evaluation Center will take a variety of measures to improve the efficiency of the review, speed up the drug review, and provide patients with more drug choices based on clinical value. Compared with the number of innovative drugs reviewed in 2022, there will be 19 more innovative drugs approved in 2023.
According to the data reported by the State Food and Drug Administration, 40 varieties of Class 1 innovative drugs will be approved for marketing in 2023, of which 9 varieties (225%) were approved for marketing through the priority review and approval process, and 13 varieties (325%) were conditionally approved for marketing, 8 varieties (20%) were included in the breakthrough drug program in the clinical research stage, and 4 new crown drugs (10%) were approved for marketing through the special approval process.
At the same time, among the 40 innovative drugs, there are 36 varieties of local innovative drugs and 4 varieties of imported drugs. In terms of drug types, there are 19 varieties of chemicals; There are 2 varieties of biological products for prophylaxis; **There are 14 varieties of biological products and 5 varieties of traditional Chinese medicine.
Among them, the company with the most approvals is the listed pharmaceutical company Wuwu Biotechnology, which has listed 3 varieties of innovative drugs, namely birch pollen allergen prick solution, Artemisia annua pollen allergen prick solution and humulus pollen allergen pricking solution. The 3 models are all first-class prick-based series diagnostic products, which are used for first-class prick test and assist in the diagnosis of type I** reactive diseases caused by related pollen sensitization. This kind of product complements each other with the "Dust Mites ** Prick Diagnostic Kit" (Guoyao Zhun Zi S20080010) and "House Dust Mites ** Prick Diagnostic Kit" (Guoyao Zhun Zi S20190022) products that have been marketed by Wuwu Biology, which can meet the allergen testing needs of more patients with allergic diseases.
Betta Pharmaceuticals will be approved for marketing in 2023 with two varieties of innovative chemical drugs, namely befatinib mesylate capsules and voronib tablets. Befatinib mesylate capsules, which were approved for marketing at the end of May, are Betta Pharmaceutical's fifth innovative drug approved for marketing, and it is the third representative of the epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)**.
The five varieties of traditional Chinese medicine that attract attention are Guangdong Siji Pharmaceutical Co., Ltd. Shenyu Ning Shen Tablets, Jianmin Pharmaceutical Children's Zibei Xuan Lung Syrup, Yiling Pharmaceutical Tongluo Mingmu Capsules, Qingfeng Pharmaceutical Citrus Citrus Total Flavonoids Tablets and Hesheng Yisheng Jixiang Lei Sugar Foot Ointment. Among them, Heyi Yisheng Jixiang Lei Sugar Foot Paste is conditionally approved for marketing.
The trading model of innovative drugs has been changed from "license in" to "license out".
At the end of 2023, Baili Tianheng announced that it would license the global rights and interests of the new EGFR HER3 ADC drug BL-B01D1 outside China to Bristol-Myers Squibb (BMS), which has become the first new bispecific antibody ADC drug in China to successfully go overseas. The down payment of US$800 million and the potential transaction total of US$8.4 billion have both broken the record of a single project of domestic innovative drugs going overseas, once again proving that the R&D strength of domestic innovative drugs has been at the forefront of the world.
The transaction between Baili Tianheng and BMS has once again ignited the market's confidence in the investment in the field of domestic innovative drugs. Industry insiders believe that the fact that these products and pipelines can go overseas is the result of the accumulation of the past 5 to 10 years, which means that 2023 will be the year when China's innovative drugs will fully shift from the "license in" model to the "license out" model.
With the improvement of domestic innovation capabilities, the achievements have taken shape, and the license out has entered an explosive period, and the number, total amount and down payment of overseas authorizations of domestic innovation achievements are higher than those of overseas innovation achievements. According to CMB research data, there will be 93 domestic license out projects in 2023, of which 46 projects will disclose the total transaction value, and the total transaction value will be as high as 455$7.3 billion, and the down payment is also as high as 28$6.6 billion. Among them, the down payment and total transaction value increased by 52% year-on-year compared to 202276% and 10118%。
Especially in Q4 2023, the down payment in a single quarter will reach 23$100 million, more than 14 in 2022The total down payment of $2.4 billion and the total transaction volume in Q4 2023 reached 279$3.4 billion, basically the same as 29.8 for the whole of 2023$3.3 billion was flat, far exceeding the $15.4 in 2021$5.9 billion in total transaction value. In the month of December, a total of 12 license out transactions were generated in China, with a down payment of 11$4.5 billion, representing 40% of the down payment for the full year and close to 80% of the down payment for the full year of 2022. The total amount of transactions amounted to 150US$2.6 billion, accounting for 1 3 of the total transaction value for the year.
According to the Pharmaceutical Cube database, as of December 13, there were more than 170 license in transactions in China last year, of which 2 3 transactions were transferred by Chinese companies, followed by American companies, and some from Japan, the United Kingdom, Switzerland and other countries.
Compared to previous years, the number of license in transactions in 2023 has decreased, but the total amount is basically the same as in 2022, mainly due to the large spending of companies such as BeiGene and Huadong Pharmaceutical. In 2023, BeiGene successively introduced the ADC of Ingen Biosciences and the CDK2 inhibitor of Ensem Therapeutics, both of which exceeded US$1 billion. Huadong Medicine continued to make great efforts to make miracles, and signed cooperation agreements with 8 companies, including CARsgen, SCOHIA, Sanyou Biologics, and Arcutis, involving cell**, GLP-1 drugs and a variety of medical aesthetic products.
Looking forward to 2024 for innovative drugs.
Bank of China ** proposed in the research report that the growth of the pharmaceutical industry is still goodWhether it is the industrial side or the clinical side, the demand for innovative products is very large, and the volume of innovative products is expected to exceed market expectations, and 2024 is expected to become the first year of sales of innovative products.
Donghai ** Research Report believes that with the rapid development of the domestic biomedical innovation industry, China's biomedical enterprises are gradually gaining recognition by virtue of their strength. In 2024, a number of domestic pharmaceutical companies, such as WuXi Biologics, Mabwell, Evergreen, and Ribo, have announced that they have cooperated with overseas pharmaceutical companies to complete more than 10 external licensing transactions, including more than four transactions with a total amount of more than US$1 billion.
The intensive overseas transactions reflect the determination of China's innovative pharmaceutical companies to get rid of involution and develop towards higher quality. With the restructuring of the industry, we expect that 2024 will continue to be a year of more frequent transactions and mergers and acquisitions between pharmaceutical companies. Donghai ** research report said.
Guotai Junan pointed out in the 2024 annual strategy report that China's innovative drugs have moved from the era of "quantitative change" to the era of "qualitative change", some new drugs have shown greater potential for clinical benefits, and domestic new drug BD has been approved for overseas and overseas marketing one after another. At present, the revenue of blockbuster new drugs of innovative pharmaceutical companies has increased rapidly, the R&D and sales expense indicators have improved, the profitability has increased, and the commercialization has entered an accelerated harvest period.
Xingye ** Pharmaceutical Research Report believes that there is a very good example of Made in China going overseas, differentiated "Chinese innovation" is about to move from innovative drug clinical to commercialization, and cost-effective "Chinese Intelligent Manufacturing" is also gradually breaking through the overseas high-end market.
The demand of the innovative drug industry chain is expected to recover next year. In recent years, the innovative drug industry chain has undergone a long period of adjustment, and the overall valuation has been adjusted to a historical low, and it is expected to usher in a recovery with the improvement of the investment and financing environment. Judging from the overseas situation, there has been some positive trend from the previous month.
The above content is based on public data analysis and research and does not constitute any investment advice. ）
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