New drug outbreak!

With the encouragement and support of a series of laws, regulations and policies, China's innovative drug research and development achievements are becoming more and more prominent
.
According to statistics, in the past five years, a total of 59 national class 1 new drugs have been approved for marketing in China, and last year it reached 22, a new high
.
At present, with the continuous improvement of national policies, many domestic companies continue to increase the research and development of innovative drugs, and relevant results are still emerging
.
Recently, a number of pharmaceutical companies have released news of new drug approvals, including new indications, orphan drug designation, clinical trials reaching the primary endpoint, etc.
, involving a large number of companies such as Luye Pharma and Betta Pharmaceuticals
.
On March 9, Livzon Group stated on the investor interaction platform that the company's cetrerelix acetate for injection has been approved for listing in the near future; triptorelin acetate microspheres for injection (one-month sustained release) and recombinant humanized Anti-human IL-6R monoclonal antibody injection has been reported
.
On March 8, China Biopharmaceutical Co.
, Ltd.
announced that the first-class innovative drug TDI01 suspension independently developed by its subsidiary Tide Pharmaceuticals was approved by the State Food and Drug Administration of China on March 3, 2022 for the development of pneumoconiosis.
clinical trials
.
TDI01 is an oral small-molecule drug with a new target and a new mechanism.
Currently, the indications for clinical trials are pulmonary fibrosis, non-alcoholic steatohepatitis, etc.
, and it is the first-in-class variety in the field of indications
.
On the same day, Sihuan Pharmaceutical announced that XZP-KM257, the first class 1 macromolecule innovative drug independently developed by Xuanzhu Bio, a subsidiary of the Group, has been approved for clinical trials, and is indicated for the treatment of advanced solid tumors with medium and high expression of HER2+.

.
On March 4, Betta Pharmaceuticals received the "Approval Notice for Supplementary Drug Application" (Notice No.
: 2022B00904, 2022B00905, 2022B00906) issued by the National Medical Products Administration (hereinafter referred to as "NMPA").
Zizumab injection (trade name: Beantine®) is intended to be used for the treatment of patients with recurrent glioblastoma, epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, cervical cancer and other indications.
Approved by NMPA.
.
.
In general, with the active deployment of pharmaceutical companies, it can be clearly found in recent years that domestic pharmaceutical innovation is entering a jump period from quantitative growth to qualitative improvement, and some fields are following and running simultaneously.
to start leading
.
However, at the same time, it should be noted that there are great uncertainties in the research and development of new drugs at present.
The characteristics of huge investment in new drug research and development, long return time and high risk are also restricting the innovative research and development of new drugs in China
.
In this regard, industry insiders believe that domestic pharmaceutical companies need to continue to make breakthroughs in innovation and try more new ways
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.