New breakthrough in the field of anti-fibrosis, Ted's overseas authorization sets a record

5;">At the beginning of the Lunar New Year in 2021, there is great news of Chinese innovative drugs.
The Hong Kong Stock Exchange's Hang Seng Index Stock China Biopharmaceutical Co.
, Ltd.
announced yesterday that the company's Beijing Tide Pharmaceutical Co.
, Ltd.
independently developed an innovative drug for the treatment of fibrosis "TDI01" has reached an overseas licensing cooperation agreement with the American company Graviton Bioscience, and the two parties will work together Developed and commercialized this inhibitor based on the new target ROCK2.
The total value of the transaction reached US$517.
5 million, setting a record for China's foreign authorization of oral small molecule drugs.
TDI01 has also achieved the "zero breakthrough" of China's independent innovative anti-fibrosis targeted drug, and will soon launch a clinical trial of new coronary pneumonia in the United States.

5;">Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, and fibrotic interstitial lung disease that occurs mostly in middle-aged and elderly people.

5;">According to GlobalData database forecasts, the global market for idiopathic pulmonary fibrosis will reach 3.
5 billion U.
S.
dollars in 2025.
Due to the huge clinical demand, it has become a hot area of ​​research and development by major R&D companies.

5;">Obtained the national major new drug creation support FDA approval for clinical trials in the United States

5;">To this end, in January 2017, Tide Pharmaceuticals formally established the first original innovative drug project-a class 1 small molecule drug TDI01 for the treatment of idiopathic pulmonary fibrosis, which was awarded by the Chinese Academy of Medical Sciences and Peking Union Medical College.
The care and guidance of Academician Wang Chen, the dean of the academy and vice president of the Chinese Academy of Engineering.
The project received national major new drug creation support in 2018.
In January 2020, Tide Pharmaceuticals submitted a TDI01 clinical trial application to the U.
S.
FDA, and submitted a clinical trial application to the Center for Drug Evaluation (CDE) of the China National Medical Products Administration in July, and both have been approved.
Currently, TDI01 has launched a phase 1 clinical trial in the United States and is progressing smoothly.

5;">TDI01 is an oral small molecule drug with a brand-new target and a brand-new mechanism.
It is a highly selective Rho/Rho-related coiled-coil forming protein kinase 2 (ROCK2) inhibitor.
The current clinical trial indication is pulmonary fibrosis.
First-in-class varieties in the field of indications.
Preclinical studies on pulmonary fibrosis have shown that TDI01 can inhibit the process of fibrosis and immunomodulate by inhibiting ROCK2, and its efficacy is better than similar listed drugs.
In addition, TDI01 has also shown beneficial effects in the preclinical evaluation of non-alcoholic steatohepatitis and a series of other fibrotic diseases, and it is expected to be clinically applied to multiple fibrotic diseases in the future.

5;">This overseas authorization cooperation adopts a phased milestone payment method, and Tide Pharmaceuticals reserves all rights in Greater China.
China Biopharmaceuticals stated that in the license out business negotiations, many overseas companies fully affirmed the team's R&D strength in the ROCK2 target.
The reason why Ted chose the US company is also based on the other party's rich R&D experience on the target.
Both parties believe that more potentials of ROCK2 targets can be tapped in the future.

5;">This strategic cooperation fully integrates the advantages of the R&D and investment teams of both parties.
China Biopharmaceuticals can not only promote TDI01, an innovative drug to the world, but also further simultaneously evaluate the potential of the drug in multiple indications and give full play to it.
The greatest value of this innovative drug allows Chinese innovative drugs to benefit more patients around the world.

5;">According to the TOP50 list of global pharmaceutical companies released by Pharm Exec in the United States in 2020, China Biopharmaceuticals ranks 42nd.
Since its establishment, it has been deeply engaged in innovative drug fields such as liver disease, respiratory, tumor, analgesia, and microcirculation.
The strong R&D strength is also an important reason to promote the cooperation with the United States.
(Sina Pharmaceutical News)