Stone Medicine Group and other transfers to research products overseas rights and interests domestic innovative drugs accelerate to go to sea

Since the beginning of this year, including Stone Pharmaceutical Group, Colom Pharmaceutical, and some biotechnology companies "go out to the sea" through the License OUT model, that is, Chinese pharmaceutical companies have given their products' overseas rights or global rights permits to pharmaceutical companies represented by European and American multinational pharmaceutical companies. , Get the down payment and milestone cost. After overseas pharmaceutical companies have connected the relay rod, they are responsible for clinical development, declaration, production and sales of overseas markets.

"In recent years, the innovation of Chinese local pharmaceutical companies has continued to accelerate." A pharmaceutical company who was unnamed to tell the Securities Daily reporter.

Increased domestic innovation medicine strength improvement

According to the Stone Medicine Group, the anti -CLAUDIN 18.2 antibody drugs SYSA1801 was awarded to the US Food and Drug Administration (FDA) in 2020 and 2021 for orphans used to treat gastric cancer (including cancer in the esophagus gastric) and pancreatic cancer. Drugs (for drugs for prevention, treatment, and diagnosis of rare diseases). A phase of clinical studies of a multi -center, dose increase and dose expansion are conducting in China to evaluate the product's safety, tolerance, drug metabolism dynamics, and preliminary efficacy.

According to the relevant agreement clauses issued by the Stone Medicine Group, the Stone Medicine Boulder Bio agrees to award the exclusive authorization of Elevice Oncology to develop and commercialize the product in the region. Stone medicine boulder creatures will charge $ 27 million in down payment, and have the right to collect potential development and regulatory milestones with a maximum of $ 148 million and the potential sales milestone payment of up to $ 1.02 billion. Stone medicine boulder biology also has the right to collect a sales commission with a net annual sales of the product in the region of the region. Stone medicine boulder creatures will retain all rights of the product in Greater China.

In addition to the Stone Medicine Group, in May this year, Coron Pharmaceutical announced that its subsidiary Coronbutai signed a amendment to Meridon on May 13 to make it a biomolecular tumor project A with independent intellectual property rights. Exclusive permission to the commercial development of Murisha East (MSD) outside China. On July 26, Coron Pharmaceutical announced that Coronbo and Merck signed a license agreement again. Coronboita will give Merhado a global scope to Merhado Internal research, development, manufacturing and commercialization.

The number of License OUT cases gradually increased, mainly due to the soaring investment in my country's pharmaceutical innovation. The "2021 Annual Drug Review Report" shows that in 2021, the National Drug Administration's Pharmaceutical Review Center approved or proposed to approve the application for innovative drug registration for 1,628 pieces, an increase of 67.32%year -on -year.

"As the domestic innovation environment continues to improve, the research and development capabilities of Chinese pharmaceutical companies have gradually improved, and the R & D pattern has become more international and advanced, especially in the fields of antibodies and new crown vaccines. At the same time, the capital market also provides innovative drug research and development. Important motivation. "The above -mentioned pharmaceutical companies who did not want to name to reporters introduced to reporters.

Seize overseas markets

From the perspective of the industry, domestic and international factors have promoted domestic innovative drugs to accelerate the overseas.

In the country, increasing competition has led enterprises to go to the sea to seek a broader market space. The above -mentioned pharmaceutical companies who do not want to be named told reporters that the implementation of the policies such as collecting and mining has forced corporate innovation, and the development of international markets has become an industry consensus.

Liu Youhua, deputy director of the Wealth Research Department of Paiwang.com, told a reporter from the Securities Daily that due to factors such as research and development homogeneity, enterprises had to go out to the sea to seek market space.

The success of going to sea means a broader market. The research report released by Southwest Securities stated that "overlooking the other side of the Pacific Ocean, US medical expenditure is four times that of China, and per capita medical expenditure is fifteen times in China. High pricing and high penetration rates are expected to amplify the value of innovative drugs ten times."

"The overseas innovation drug market has a huge potential and has achieved international integration in the regulatory system. In 2017, China joined ICH. Domestic clinical trials were in line with international standards. It should focus on the selection of innovative drug indications and the breakthrough of targets, to achieve differentiated innovation, and lay the foundation of going out to sea. "The above -mentioned pharmaceutical companies said.

"The per capita medical expenditure of overseas markets is much higher than that of China, and the pricing is also high. As my country's innovative drugs increase, the number of clinical trials exceeds the United States, and the quality of innovative drugs increases. Daily reporter said.

Our reporter Zhang Min Zhang Xiaoyu

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