Recently, Sichuan Kelun Pharmaceutical Co.Ltd(002422) authorized the biomacromolecule tumor project to multinational pharmaceutical giant MSD, with a transaction amount of more than 1.3 billion yuan. Domestic innovative drugs "going to sea" once again attracted attention. Industry insiders believe that with the improvement of the R & D capability of China Meheco Group Co.Ltd(600056) enterprises, the overseas market has become a must for pharmaceutical enterprises, and overseas authorization is one of the ways for pharmaceutical enterprises to "go to sea".
However, it is not easy for domestic innovative drugs to "go to sea". Since this year, many applications for overseas listing of domestic drugs have been frustrated. In this regard, industry insiders said that overseas clinical trials may become an important condition for China's innovative drugs to "go to sea". Domestic innovative drugs that meet regulatory requirements, solve "unmet" clinical needs and have high-quality clinical data have greater international commercial value.
high enthusiasm for R & D
Since this year, the innovation and R & D enthusiasm of Chinese pharmaceutical enterprises has remained high.
Jiangsu Hengrui Medicine Co.Ltd(600276) in recent years, the company has accelerated innovation, transformation and upgrading, and the company's innovative drugs have ushered in a harvest period. Recently, the company successively issued announcements on the research and development progress of innovative drugs 6 Landai Technology Group Corp.Ltd(002765) on May 19, it was announced that the company's drug hrg2005 inhalant and its subsidiary hr18034 for drug injection obtained the notice of approval for drug clinical trial.
Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) announced a few days ago that Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) industry, a holding subsidiary, received a notice from the State Drug Administration on approving fcn-159 tablets to be used in clinical trials for tissue cell tumor treatment Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) industry plans to carry out phase II clinical trials of the indication in China (excluding Hong Kong, Macao and Taiwan) when the conditions are met.
the Research Report of China Merchants Bank Co.Ltd(600036) Research Institute shows that the research and development of domestic innovative drugs has entered the fast lane. The number of clinical applications of domestic innovative drugs has increased year by year. In 2021, the number of clinical trial applications (ind) of domestic innovative drugs increased by 104% year-on-year, a new high in recent years.
In terms of drug types, biopharmaceuticals have exploded in the global market in recent years, and the technical level of Chinese pharmaceutical enterprises has been continuously improved. After 2020, the number of domestic Chinese drugs applying for innovation has maintained an absolute growth rate of more than 100%, but the number of Chinese drugs applying for clinical innovation has remained significantly higher than that in 2020.
Domestic innovative drugs have entered the harvest period of listing. In 2021, 44 domestic innovative drugs (excluding traditional Chinese medicine and vaccines) were listed, with a year-on-year increase of 175.0%. The total number of domestic innovative drugs approved in 2021 has exceeded the sum of the previous five years. Industry insiders believe that with the continuous growth of the number of domestic innovative drugs ind, the number of domestic new drugs approved for listing will continue to grow.
In recent years, some generic pharmaceutical enterprises have listed their core innovative products, and the proportion of innovative products in their revenue has gradually increased. For biotechnology enterprises, with the core innovative drugs approved for listing and entering the commercialization stage, the sales revenue will rise year by year. In 2021, Corning Jerry, kangfang biology, Rongchang biology, nuocheng Jianhua, Yasheng pharmaceutical and other enterprises all ushered in revenue breakthroughs.
overseas authorized heavy varieties are frequently found
China's R & D speed and technical capacity of innovative drugs have increased rapidly.
Sichuan Kelun Pharmaceutical Co.Ltd(002422) recently announced that MSD will pay the down payment, various milestone payments and corresponding net sales commission to Kelun Botai according to the commercial development stage. Kelen Botai received a one-time and non refundable payment of US $17 million when the license agreement came into effect, and a one-time and non refundable payment of US $30 million after the amendment of this agreement was signed. The cumulative milestone payment shall not exceed US $1.363 billion, and a commission shall be made according to the proportion of net sales agreed by both parties.
In this regard, Gf Securities Co.Ltd(000776) believes that the research and development of innovative drugs of Sichuan Kelun Pharmaceutical Co.Ltd(002422) has been recognized by large overseas pharmaceutical enterprises, and the value is expected to be revalued.
And platinum medicine have the same authorization. On April 7, the company announced that it would discuss cldn18 with AstraZeneca The development and commercialization of 2xcd3 bispecific antibody (hbm7022) reached a global external licensing agreement. And platinum medicine will receive an advance payment of $25 million and milestone payments of up to $325 million, as well as royalties based on future hbm7022 sales.
The Research Report of China Merchants Bank Co.Ltd(600036) Research Institute shows that the R & D quality of domestic innovative drugs continued to be recognized by similar companies in 2021. From the perspective of the number of overseas authorizations, although it decreased to a certain extent compared with 2020, it increased by 121.4% compared with 2019. In terms of transaction price, the total price of overseas authorization of domestic innovative drugs in 2021 reached a new high in recent years, with a year-on-year increase of 19.3%. Considering that the number of overseas licenses has decreased compared with 2020, the average price of each overseas license in 2021 has increased significantly. In particular, the trading partners of some companies are leading enterprises in the global pharmaceutical industry and have received high down payment, indicating the recognition of foreign pharmaceutical enterprises for their products.
reduce homogeneous competition
The "going to sea" of domestic innovative drugs is not plain sailing. On the one hand, the car-t product of legendary biological targeting BCMA was approved by FDA in February 2022, and the domestic innovative drugs ushered in a milestone breakthrough again. On the other hand, since this year, many pharmaceutical enterprises such as Cinda biology have been frustrated. Among them, because the clinical trial samples of the two companies are not representative and lack the clinical data of American patients, they need to supplement the international multicenter clinical trial to support their approval in the United States.
Northeast Securities Co.Ltd(000686) believes that whether the delivery of new drugs complies with the clinical unmet needs, whether the design test is generally applicable to the North American population and North American medical practice, whether the relevant clinical trials actively communicate with FDA from the beginning to the end, and whether there are head-to-head experiments for listed drugs with the same indications will become the factors to be considered in the road of "going to sea".
China Industrial Securities Co.Ltd(601377) believes that the approval of FDA drugs can be summarized as "no one has me, no one has me", which can be divided into the following types: first drug, orphan drug, better generation of drugs with the same target and differentiated varieties of drugs with the same target and the same generation.
In fact, the original ability of Chinese enterprises still needs to be improved, and the situation of repeated research and development is serious. According to the Research Report of securities companies, according to the statistics of the drug evaluation center of the State Food and drug administration, each hot target has more than 15 manufacturers and drug layout, which is more obvious in 2021. Taking the popular target PD-1 / PD-L1 as an example, 173 drugs entered the clinic in 2021, with a year-on-year increase of 46%. In 2021, the number of newly approved domestic PD-1 / PD-L1 reached 4, which was the same as the number approved in the previous three years.
In order to avoid the waste of clinical resources, the guiding principles for clinical research and development of anti-tumor drugs guided by clinical value was released in November 2021. Focusing on the dimensions of research and development topic setting and clinical trial design, and from the perspective of patients' needs, it puts forward suggestions on the clinical research and development of anti-tumor drugs, in order to guide the applicant to implement the research and development concept of clinical value oriented and patients as the core in the research and development process, It provides an important reference for promoting the orderly development of antitumor drugs.
Brokers believe that in the medium and long term, under the guidance of the document, the innovative drug industry will reduce homogeneous competition, guide the concentration of industry capital, technology and clinical resources to innovative enterprises, and improve the industry concentration.
