Health & Beauty

According to Watson & Band Import and Export Data Observation Report, recently, there have been new developments in the development and launch of a number of new drugs in China.

On the evening of October 10, Hengrui Medicine announced that the company's innovative drug pyrotinib, which has a new indication for listing, has been accepted and is intended to be used in the first-line treatment of breast cancer. The drug is also China's first self-developed HER1/HER2/HER4 targeted drug.

Recently, the new indication of WuXi Junuo’s Regi Orensai Injection was approved for marketing for the treatment of follicular lymphoma (r/rFL); Lietin Tablets (trade name: Huatangning) was approved for marketing, becoming the first glucokinase activator drug approved for marketing in the world.

In addition, the clinical trials of innovative drugs of many companies have also made progress. Zai Lab's Efgartigimod Injection has been approved for clinical trials, and plans to conduct research on the treatment of bullous pemphigoid; The antibody CBB1 injection was clinically approved.

Class I innovative drugs are considered to be an indicator of the innovation capabilities of domestic enterprises. According to industry experts, it is difficult to establish a Class I innovative drug project, mainly because its clinical research and development is relatively difficult. In addition, innovative drugs also face the problem of market development. Although the time for innovative drugs to enter the medical insurance catalog has been adjusted to once a year, they need to face medical insurance negotiations, and there is great pressure to reduce prices. It is unrealistic to spread the market and generate cash flow in the short term.

Recently, Betta Pharmaceuticals announced that the company intends to issue shares to Ding Lieming, the actual controller, and the total amount of funds raised is expected to be no more than 1 billion yuan (including the original amount). After the fund-raising project is put into production, it will meet the production requirements of an annual production capacity of over 40 tons of innovative APIs. In terms of research and development, Betta Pharmaceuticals' new drug research and development projects continue to advance, and the R&D investment in the first half of 2022 will be 459 million yuan, a year-on-year increase of 15.27%. Among them, research and development expenses were 317 million yuan, a year-on-year increase of 30.65%, accounting for about 25% of total revenue, Huacheng Import and Export Data Observation Report.

At the end of September, in order to further enhance the service capability of the whole industrial chain of R&D and production of innovative drugs, Asymchem and the Management Committee of Taixing Economic Development Zone, Jiangsu Province signed the "Investment Agreement on Investing in the Construction of "Integrated Biopharmaceutical R&D and Production Base Project", and It is planned to spend 4 billion to 5 billion yuan for the Taixing Investment Biomedical R&D and Production Integrated Base Project.

In addition, WuXi AppTec plans to establish a research and development and production base in Singapore, and expects to invest a total of 2 billion Singapore dollars (about 1.43 billion U.S. dollars) in the construction of the new base in the next 10 years to continuously accelerate the process of pharmaceutical innovation.

According to Watson & Band Import and Export Data Observation Report, with the rise of China's biopharmaceutical industry, the deepening of international exchanges and integration, and the improvement of industry credit, the overseas rights and interests licensing (licenseout) of China's innovative drug projects is also getting better.

In terms of transaction amount, China's innovative drug projects continue to set new records. On September 29, Simcere and Almirall signed an exclusive license agreement for the preclinical stage autoimmune drug candidate IL-2 mutant fusion protein (IL-2mu-Fc) SIM0278, and will develop and commercialize SIM0278 outside of Greater China. The exclusive rights of the indications were awarded to Almirall, which received a down payment of US$15 million, and the total transaction amount reached US$500 million, setting a record for overseas authorization of preclinical projects in the field of autoimmunity in China.

In mid-August, Jemincare's subsidiary Shanghai Jiyu Pharmaceutical exclusively licensed the global development and commercialization rights of the self-developed oral androgen receptor (AR) degrader JMKX002992 to Genentech for a total amount of US$650 million. At the end of July, Jushi Biotech, a subsidiary of CSPC, authorized the development and commercialization rights of its potential "first-in-class" anti-Claudin18.2 antibody-conjugated drug outside Greater China to Elevation Oncology, with a total amount of nearly US$1.2 billion. This year, Kelun Pharmaceuticals has successively granted Merck the rights to develop, produce and commercialize two ADC drugs for solid tumors worldwide. The total down payment for the two drugs is US$82 million, and the total milestone payment is US$2.264 billion.

According to Watson & Band Import and Export Data Observation Report, in terms of overseas market selection, in addition to the European and American markets with well-developed pharmaceutical industries and sound market rules, Chinese pharmaceutical companies have also set their sights on emerging markets.

At the beginning of September, the SCO member countries held the first cooperation meeting in the field of medicine under the framework of the SCO - the Shanghai Cooperation Organization Pharmaceutical Cooperation and Development Conference. At the meeting, the "Initiative on Promoting the Establishment of Pharmaceutical Industry Cooperation under the Framework of the Shanghai Cooperation Organization" was released to support the strengthening of drug regulatory exchanges and cooperation, actively promote the establishment of a more efficient and win-win international cooperation model for international drug and medical device research and development under the framework of the Shanghai Cooperation Organization, and promote the international pharmaceutical industry. Approval and regulatory cooperation, with key products and key areas as a breakthrough, to achieve regulatory mutual recognition and market co-prosperity.

As China gradually becomes an important participant in the global biopharmaceutical ecosystem, Chinese companies are becoming one of the sources of global pharmaceutical innovation and change, reports Watson & Band Import and Export Data Observation.