Health & Beauty

According to the observation report of Huacheng's import and export data, recently, new progress has been made in the research, development and marketing of many new drugs in China.

On the evening of October 10, Hengrui Pharmaceuticals announced that the application for listing the innovative drug pyrrolidine with new indications was accepted, and it was intended to be used for first-line treatment of breast cancer. This drug is also the first independently developed HER1/HER2/HER4 targeted drug in China.

Recently, a new indication of the drug, Mingjunuo, was approved for marketing for the treatment of follicular lymphoma (r/rFL); Duoglietin tablets (trade name: Huatangning), which are used by Hualing Pharmaceutical to treat adult type II diabetes, have been approved for marketing, becoming the first glucokinase activator drug approved for marketing in the world.

In addition, many companies have also made progress in the clinical application of innovative drugs. The Efgartigimod injection of Zaiding Pharmaceutical has been approved for clinical use, and it is planned to carry out research on the treatment of bullous pemphigoid; Changchun Baike also announced that it had received the Notice of Drug Clinical Trial Approval, and the company's natural all human anti rabies virus monoclonal antibody CBB1 injection was clinically approved.

Class I innovative drugs are considered as a wind vane of the innovation ability of domestic enterprises. Industry experts said that it was difficult to establish Class I innovative drugs, mainly because of the difficulty in clinical research and development. In addition, innovative drugs also face difficulties in market development. Although the time for innovative drugs to enter the medical insurance directory has been adjusted to once a year, they need to face medical insurance negotiations, and there is a great pressure to reduce prices. It is unrealistic to spread the market and form cash flow in a short term.

Recently, Beida Pharmaceutical announced that the company plans to issue shares to Ding Listing, the actual controller, and the total amount of funds raised is expected to not exceed 1 billion yuan (inclusive). When the fund-raising project reaches its capacity, it meets the production requirements of an annual production capacity of over 40 tons of innovative APIs. In terms of R&D, the new drug R&D project of Beida Pharmaceutical continued to advance, with a semi annual R&D investment of 459 million yuan in 2022, a year-on-year increase of 15.27%. Among them, R&D expenditure was 317 million yuan, with a year-on-year growth of 30.65%, accounting for about 25% of the total revenue. Huacheng Import and Export Data Observation Report.

At the end of September, in order to further improve the service capacity of the whole industrial chain of innovative drug R&D and production, Carlaying signed the Investment Agreement on Investing in the Construction of "Biomedical R&D and Production Integration Base Project" with the Management Committee of Jiangsu Taixing Economic Development Zone, and planned to invest 4 billion to 5 billion yuan in the biomedical R&D and production integration base project of Taixing.

In addition, WuXi AppTec plans to establish a research and development and production base in Singapore, and is expected to invest a total of S $2 billion (about US $1.43 billion) in the next 10 years for the construction of new bases, constantly accelerating the process of pharmaceutical innovation.

According to the observation report of Huacheng import and export data, with the rise of China's bio pharmaceutical industry, the increase in the depth of international exchanges and integration, and the improvement of industry credit, the overseas rights and interests licensing of China's innovative drug projects is also getting better.

In terms of transaction amount, China's innovative drug projects have kept breaking new records. On September 29, Pioneer Pharmaceutical signed an exclusive licensing agreement with Almirall on the preclinical autoimmune candidate drug IL-2 mutant fusion protein (IL-2mu Fc) SIM0278, granting Almirall the exclusive right to develop and commercialize all the indications of SIM0278 outside Greater China. For this reason, it received a down payment of 15 million dollars, with a total transaction amount of up to 500 million dollars, setting the highest overseas licensing record for preclinical projects in the field of autoimmune in China.

In the middle of August, Jiyu Pharmaceuticals, a subsidiary of JMC, exclusively licensed the development and commercialization rights of JMKX002992, a self-developed oral androgen receptor (AR) degrading agent, to Genentech in the world, with a total amount of up to 650 million US dollars. At the end of July, Jushi Biologics, a subsidiary of Shijiazhuang Pharmaceutical Group, authorized the rights and interests in the development and commercialization of its potential "first in class" anti Claudin18.2 antibody coupling drug outside Greater China to ElevationOncology, with a total amount of nearly 1.2 billion dollars. This year, Kelun Pharmaceutical has granted MSD the rights and interests to research, develop, produce and commercialize two solid tumor ADC drugs worldwide. The down payment for the two drugs totaled $82 million, and the milestone payment totaled $2.264 billion.

According to the Huacheng Import and Export Data Observation Report, in terms of overseas market selection, in addition to the European and American markets where the pharmaceutical industry is developed and the market rules are perfect, Chinese pharmaceutical enterprises also focus on emerging markets.

At the beginning of September, SCO member countries held the first pharmaceutical cooperation conference under the SCO framework - the SCO Conference on Pharmaceutical Cooperation and Development. At the meeting, the Initiative for Promoting the Establishment of Cooperation in the Pharmaceutical Industry under the SCO Framework was released, which supported the strengthening of drug regulatory exchanges and cooperation, actively promoted the establishment of a more efficient and win-win international drug and medical device research and development cooperation model under the SCO framework, promoted international drug approval and supervision cooperation, and achieved mutual recognition of supervision and mutual prosperity of the market by taking key products and fields as breakthrough points.

As China has gradually become an important participant in the global biopharmaceutical ecosystem, Chinese enterprises are becoming one of the sources of global pharmaceutical innovation and change, Huacheng Import and Export Data Observation reported.