Wuhan pharmaceutical company's innovative anti-cancer drug was approved for clinical trial


　　 , the first cell therapy product targeting CD30 in China

　　□ Changjiang Daily reporter Liu Ruiche

　　The anti-cancer drugs worth 1.2 million yuan per injection have attracted attention recently.

A reporter from Changjiang Daily learned that cellular immunotherapy is an internationally cutting-edge treatment method in the field of hematological tumors, and the development of innovative drugs is fiercely competitive.

Wuhan pharmaceutical companies obtained the only national clinical trial approval on one of the tracks, and the new drug is expected to be launched by the end of next year or the year after.

　　■ Wuhan pharmaceutical company received clinical trial approval

　　The new drug is expected to be launched next year

　　High prices and crowded tracks are the current status of CAR-T-related innovative drugs.

　　Wuhan pharmaceutical companies are stepping up the pace of research and development.

The reporter saw in Wuhan Borida Biotechnology Co., Ltd. (“Borida” for short) that the State Drug Administration issued a clinical trial notification that approved it to treat relapses and difficulties on the target of CD30 between the ages of 18 and 70. Carry out clinical trials for patients with curative hematological tumors.

　　According to public data, there are currently 475 studies on CAR-T in China, surpassing the 279 in the United States.

Up to now, China has 358 ongoing CAR-T clinical trials.

　　The reporter inquired about the "Drug Clinical Trial Registration and Information Disclosure Platform" and found that only Perida was the only CAR-T clinical trial on the CD30 target.

　　"We are starting clinical trials." According to Zhang Tongcun, the person in charge of Perida and dean of the School of Life Sciences and Health of Wuhan University of Science and Technology, if it goes well, new drugs are expected to be on the market from the end of next year to the next year.

　　Generally, clinical trials need to be conducted in Phase 3 before new drugs can be marketed. For innovative anti-tumor drugs, the State Food and Drug Administration has approved the green channel, and after completing Phase 2 clinical trials, they can be approved for conditional listing.

Such innovative drugs in the United States are also marketed under this model.

　　Companies have adopted differentiated declarations, innovated from the source, and selected more novel CD30 target declarations.

In addition to CD30, CD99 is also considered to be a promising therapeutic target. Perida has obtained a domestic patent for this target and is currently applying for an international patent.

　　Why is this "medicine" so expensive?

According to Zhang Tongcun, the cost of preliminary research and development, the cost of in-treatment testing, personalized customization, and the cost of high-value patent protection will all drive up the price of medicines.

　　Such drugs are more expensive in foreign countries. For example, the CAR-T product developed by Novartis for the treatment of leukemia is priced at 475,000 US dollars, which is equivalent to about 3.06 million yuan.

　　Take Perida as an example. Since 2014, the company has gone through 7 years of CAR-T exploration. The initial investment has exceeded 100 million, and no CAR-T product has actually been launched.

However, Zhang Tongcun is full of confidence, "Drug research and development is a recognized high-risk and high-input industry, and this is also a process that China's innovative drugs must go through."

　　Porui Da has now developed into a small giant company in Optics Valley, and is also a listed silver seed company in Wuhan, and it is in the B round of financing.

　　■ Continued localization of innovative drugs

　　Bring room for price reduction

　　The localization of innovative drugs will greatly reduce the corresponding costs.

For example, to genetically modify T lymphocytes, a lentivirus is used. The import of this lentivirus from the UK costs US$22,000, and the company’s own production costs only more than 300 yuan.

　　It is reported that there are at least 7 CAR-T-related technology products currently undergoing phase 2 clinical trials in China.

　　Zhang Tongcun estimated that there will be a batch of domestic innovative CAR-T drugs on the market from the second half of next year to the next year.

With the advancement of domestic drugs, coupled with the participation of medical insurance or commercial insurance, anti-cancer drugs such as this 1.2 million yuan per injection will have a greater room for price reduction in the future.

　　WuXi Biotech Co., Ltd. disclosed in its prospectus that China's CAR-T therapy market will continue to expand in the future. It is estimated that China's CAR-T therapy market will reach 5.4 billion yuan in 2024 and 24.3 billion yuan in 2030. .

　　For Zhang Tongcun, Wuhan is half a hometown.

He is from Shandong, spent his college time in Wuhan, and his wife is also from Hubei.

　　Over the years, from starting a company in Optics Valley to growing into a giant and preparing to go public, Wuhan has made him feel warm and supportive at every step.

　　"Innovative drugs will pay a high cost, but in the end it is for patients to get effective and accessible treatment." Zhang Tongcun said.