In the 100 billion small molecule drug market, the innovation of domestic pharmaceutical companies has begun to enter the harvest period

【Pharmaceutical Network Market Analysis】In recent years, although with the emergence of many innovative biotechnologies such as antibodies, gene therapy, cell therapy, ADC, oncolytic virus, etc.
, the number of small molecule drugs developed has further slowly
declined.
However, due to the greater advantages of R&D cost and process maturity compared with biological macromolecule drugs, the former is still the main battlefield
for new drug research and development.
At present, in China, many pharmaceutical companies are also very optimistic about the small molecule drug market and are increasing their layout
.
It is worth mentioning that in recent years, pharmaceutical companies have continuously produced new achievements
.
For example, on November 22, Salubris announced that the clinical trial application of SAL0119 tablets, an oral small molecule immunosuppressant independently developed by the company, was accepted by the State Food and Drug Administration, and the clinical indications to be developed for the drug include active ankylosing spondylitis and moderate to severe active rheumatoid arthritis
.
Salubris said that SAL0119 has a unique mechanism of action different from JAK and broad-spectrum cytokine inhibition, and preclinical research data reflect good efficacy and safety
.
If successfully developed and approved for marketing, it will provide new drug options for patients with these two major diseases and meet the unmet clinical needs
.
Prior to this, Tianjin Hongri Pharmaceutical issued an announcement that the marketing application for tosylamamide injection submitted by its shareholding subsidiary, Tianjin Hongri Jiandakang Pharmaceutical Technology Co.
, Ltd.
, was approved by NMPA, and the indication was: central non-small cell lung cancer
with severe airway obstruction.
This drug is a small molecule drug for the treatment of advanced solid tumors, and it is also the first anti-cancer drug
with low toxicity, high efficiency, broad spectrum and specific recognition staining administered by injection into the tumor.
The marketing application was accepted in 2018 and approved for marketing in November 2022 for the treatment of central non-small cell lung cancer
with severe airway obstruction.
In addition, in early November, Ascletis also announced that ASC61, an oral small molecule inhibitor of PD-L1 independently developed by the company, was approved by the National Medical Products Administration of China (NMPA) to carry out a new drug clinical trial (IND) application for the treatment of advanced solid
tumors.
The US Phase I dose-escalation study of ASC61 is progressing in an orderly manner, and the approval of the Chinese IND will accelerate the global development
of ASC61.
It is reported that ASC61 is an oral small molecule inhibitor prodrug
.
Its advantages are: convenient and safe administration, no need to go to the hospital for injection, and higher patient compliance; Easily form an all-oral combination regimen with other oral antineoplastic drugs; Flexible dosing for better management of immune-related adverse events; The cost is relatively lower; Higher
permeability against tumor tissue.
It can be clearly seen from the above that with China's continuous attention to the research and development of innovative drugs and the increase of investment, the harvest period has begun in the field of small molecules
.
It is worth noting that Frost & Sullivan's data shows that China's small molecule tumor targeted therapy market has increased from 8.
5 billion yuan in 2016 to 37.
5 billion yuan in 2020, and is expected to reach 120.
5 billion yuan by 2025 and further increase to 207 billion yuan
in 2030.
In this context, the small molecule drug market of domestic pharmaceutical companies may be further developed
.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.