CSPC's new drug has been approved for clinical trials, and its product pipeline will be further enriched

Under the normalization of centralized procurement, the competition in the generic drug business of traditional pharmaceutical companies has become increasingly fierce, and many companies have realized that the generic drug business can no longer meet the growing demand for clinical drugs, and began to adjust the focus of research and development to special preparations with higher technical thresholds and the field of
macromolecular innovative drugs with global competitiveness 。 Recently, CSPC Pharmaceutical Group announced that the emulsion for clovidipine butyrate (50ml: 25mg, 100ml: 50mg) developed by Sino Pharmaceutical (Shijiazhuang) Co.
, Ltd.
, a subsidiary of the group, has been approved by the National Medical Products Administration and can carry out clinical trials
in China.
According to public information, clevidipine butyrate is a dihydropyridine calcium channel blocker suitable for the treatment of hypertension
when oral antihypertensive drugs are not suitable or cannot achieve satisfactory results.
It is worth mentioning that this product is the first nanoemulsion
developed by CSPC Group.
The approval of the clinical trial of this product marks the further enrichment
of the Group's special formulation technology platform.
It is understood that special preparations are a complex class of drug loading systems, including microspheres, liposomes, microemulsions, suspended injections (nanoparticles, nanocrystals).

Due to its unique clinical advantages, high technical barriers, high added value, and the advantages of avoiding homogeneous competition between enterprises to a certain extent, it is being increased by many pharmaceutical companies
.
In China, special preparations have become one of
the mainstream directions of domestic innovation and research and development.
Among them, in the field of microspheres, companies such as Lizhu and Luye currently have a number of microsphere products under development, and many products have entered phase III clinical trials and are expected to usher in the commercialization stage
.
For example, on July 19, 2022, Luye Pharmaceutical Group announced that its phase III clinical trial of rotigotine for injection sustained release microspheres (LY03003) for the treatment of Parkinson's disease in China reached the preset endpoint
.
In the field of nanocrystals, at this stage, Qilu Pharmaceutical, Shengzhao Pharmaceutical, and Hunan Kelun have been developing generic drugs for olanzapine dihydroxynaphate for injection and aripiprazole long-acting intramuscular injection
.
In addition, in the field of liposomes, the main R&D companies are Hengrui, CSPC, Luye and other well-known domestic pharmaceutical companies
.
At present, there are a number of liposomal injections under research, including irinotecan hydrochloride liposome injection, paclitaxel liposomes for injection, vincristine sulfate liposomes for injection, amphotericin for injection, rice liposomes and dozens of liposome injection projects under research, and the indications mainly involve liver cancer, lung cancer, breast cancer, gastric cancer and other cancer fields, as well as fungal infections, postoperative analgesia and other fields
.
The analysis believes that special injections are increasingly concerned by domestic pharmaceutical companies, and continue to make new breakthroughs in China, which is inseparable from the support
of policies.
It is understood that as early as January 2022, the Ministry of Industry and Information Technology, the National Development and Reform Commission and other 9 departments jointly issued the "14th Five-Year Plan" for the development of the pharmaceutical industry, proposing to focus on the development of complex preparation technologies with high selectivity and long-term sustained and controlled release in terms of chemical technology and other characteristics, including injections such as microspheres, oral preparations such as sustained and controlled release, multi-particle systems, percutaneous, implanted, inhalation, oral-dissolved film drug delivery systems, drug-device combination products, etc
。 On February 25, 2020, the state issued the "Opinions on Deepening the Reform of the Medical Security System", which clearly emphasizes the acceptance and review of the consistency evaluation of the quality and efficacy of generic drugs, supports the development and use of high-quality generic drugs, and promotes the substitution
of generic drugs.
Subsequently, CDE also issued the "Technical Guidelines for the Research of Generic Drugs of Doxorubicin Hydrochloride Liposome Injection" (Draft for Comments), and continued to promote the consistency evaluation of
special injections.
In the future, under the favorable policy, the innovation of special injection products by pharmaceutical companies is expected to continue to accelerate, and the price of drugs in this field can be reduced as a whole, so that more and more patients can use cheap and beautiful drugs
.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.