Since the beginning of this year, Unocal, Kelun Pharmaceutical and some biotechnology companies have "gone out to sea" through the licenseout model, that is, China pharmaceutical companies have authorized the overseas rights and interests of their products to pharmaceutical companies represented by European and American multinational pharmaceutical companies, and received down payment and milestone fees. After receiving the baton, overseas pharmaceutical companies are responsible for clinical research and development, listing, production and sales in overseas markets.
"In recent years, the innovative drugs of local pharmaceutical companies in China have continued to accelerate." A pharmaceutical company person who did not want to be named told the Securities Daily reporter.
The strength of domestic innovative drugs has improved.
Unacon introduced that the anti-Claudin 18.2 antibody drug conjugate Sya1801was awarded by the US Food and Drug Administration (FDA) to treat gastric cancer (including cancer at the junction of esophagus and stomach) and pancreatic cancer (prevention, treatment and diagnosis of rare diseases) in 2020 and 2002 respectively. A multi-center, increased dose and expanded dose phase I clinical study is being conducted in China to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of this product.
According to the terms of the relevant agreement issued by Unacon, Shi Yao Jushi Bio agreed to grant ElevationOncology the exclusive authorization to develop and commercialize this product in this field. Shi Yao Jushi Bio will receive a down payment of $27 million, and is entitled to a potential development and regulatory milestone payment of up to $654.38+$48 million and a potential sales milestone payment of up to $654.38+$20 million. Stone Medicine Jushi Bio also has the right to charge a sales commission of up to double-digit percentage according to the annual net sales of this product in this area. Stone and stone creatures will retain all rights of this product in Greater China.
In addition to Unacon, in May this year, Kelun Pharmaceutical announced that its subsidiary Kelun Taibo signed an amendment to the License Agreement with Merck on May 13, and exclusively licensed its biomacromolecule tumor project A with independent intellectual property rights to Merck (MSD) for commercial development outside China. On July 26th, Kelun Pharmaceutical announced that Kelun Taber had signed a license agreement with Merck once again, and Kelun Taber gave Merck a paid exclusive license for R&D, manufacturing and commercialization on a global scale.
The number of cases of licenseout is increasing gradually, mainly due to the surge of investment in medical innovation in China. The annual drug evaluation report of 2002/kloc-0 shows that in 20021year, the drug evaluation center of the State Administration of Pharmaceutical Products approved or recommended 1628 innovative drug registration applications, with a year-on-year increase of 67.32%.
"With the continuous improvement of the domestic innovation environment, the R&D capabilities of pharmaceutical enterprises in China have gradually improved, and the R&D model has become more international and advanced, especially in the fields of antibodies and COVID-19 vaccines. At the same time, the capital market has also provided an important impetus for the research and development of innovative drugs. " The above-mentioned pharmaceutical companies who did not want to be named told reporters.
Seize overseas markets
In the eyes of the industry, domestic and foreign factors have promoted domestic innovative drugs to accelerate the sea.
At home, the intensification of competition has led enterprises to go out to sea to seek broader market space. The above-mentioned pharmaceutical companies who did not want to be named told reporters that the implementation of policies such as centralized procurement has forced enterprises to innovate and develop the international market, which has become common sense in the industry.
Liu, deputy director of the wealth research department of Paipai. com, told the Securities Daily reporter that due to factors such as homogenization of research and development, enterprises had to go out to sea to seek market space.
Success at sea means a broader market. According to the research report released by Southwest Securities, "Looking across the Pacific Ocean, the medical expenditure of the United States is four times that of China, and the per capita medical expenditure is fifteen times that of China. High pricing and high permeability are expected to amplify the value of innovative drugs by 10 times. "
"The overseas innovative drug market has great potential and has achieved international integration in the regulatory system. China joined ICH in 2065438+2007, and domestic clinical trials are in line with international standards. More and more local pharmaceutical companies set up international multi-center clinical trials overseas. Pharmaceutical companies should focus on the indication selection and target breakthrough of innovative drugs, achieve differentiated innovation, and lay a good foundation for going to sea. " The above-mentioned pharmaceutical companies said.
"The per capita medical expenditure in overseas markets is ten times higher than that in China, and the pricing is also high. With the increase in the number of innovative drugs IND in China, the number of clinical trials surpassing that in the United States and the improvement in the quality of innovative drugs, there is great potential for innovative drugs to go to sea in the future. " Liu told the Securities Daily reporter.
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