The new crown medicine enters clinical research densely, revealing positive signals

On September 25, Guangshengtang announced that the GST-HG171 has been approved by the Pharmaceutical Supervision Bureau to enter the clinic.

The domestic epidemic has not been completely extinguished, but society seems to no longer pay attention to the treatment of new crowns. However, after the pharmaceuticals of Guangshengtang were allowed to enter the clinic, CDE successively approved TDI01 of Ted Pharmaceuticals, a subsidiary of China Biopharmaceutical, and FB20001, which is used for cutting -edge biology after the exposure of the new crown.

Earlier, GS-00202, an oral new crown drug developed by West Lake University, and GS-00202, Shanghai Gu Sen Pharmaceutical, were approved to enter clinical trials on September 6.

On September 28, Merck's agreement with the National Medicine Group to authorize the new crowned medicine Monorawell to the National Medicine Group. At present, only Paxlovid and real creature in the domestic market are approved for two oral medicines. At this time, Mer Shadong's choice to authorize to the National Medicine Group will inevitably accelerate the approval progress of the new crown oral medication.

The new crown oral and input drugs are intensive into the clinic, or can promote some policy adjustments.

Multiple products enter the clinic

The new crown oral medicine of Guangshengtang has just entered the clinic, and the production capacity has been prepared: with the capacity of 60 million people, and it can increase to 100 million people in the future.

On September 26, the news announced the next day, Guangshengtang's stock price rose 5.16%.

Earlier, the product pipelines of Guangshengtang were mainly anti -hepatitis B virus drugs and liver protection and liver -protecting drugs. Since the listing of IPOs in 2015, the company has transformed to innovative pharmaceutical companies and expanded anti -new coronary virus drug pipelines.

The research and development of Guangshengtang's new crown drug GST-HG171 has begun in early 2020 and has been in the early three years. Clinical studies have shown that it has strong known new crown virus strains, including Omikon.

After three years of polishing the new crown medicine, can it boost that Guangshengtang has a bleak performance?

Cutting -edge creatures and Chinese biopharmaceuticals break through from other perspectives.

The core company of Chinese biopharmaceuticals, Zheng Datianqing, had previously had respiratory drugs. This time, the clinical TDI01 took a different approach, avoiding the mainstream target 3CL and RDRP of the new crown medicine, and developed the world's first Rock2 target drug. Before the new crown indication, TDI01 has progressed in the pneumoconiosis, pulmonary fibrosis and other indications, and is expected to become a heavy drug of the respiratory system.

Cutting -edge creatures have also been deeply cultivated in the field of antiviral virus. Its atomization inhalation with new crowns FB2001 has entered the clinic before entering the clinic. Different from injection for patients with new coronary pneumonia, inhalation medication is intended to treat light and ordinary new crown infections, and is planned to be used for prevention after the exposure of the new coronal virus.

The above three varieties have a certain innovation from different angles.

Coupled with the new crown drugs of West Lake University, Gensen Pharmaceutical, Cingxing Pharmaceutical, and Ge Li Pharmaceutical, which had previously entered the clinic, since the third quarter of this year, there have been 7 new crown drugs in China that have entered the clinic. If you add earlier varieties such as first -vocal pharmaceuticals, Junshi Biology, and Pharmaceuticals, there are already 10 drugs in clinical stages.

The demand gap is huge

There are also several new crowns that have been carried out for clinical research very early, and gradually disappeared.

The news of Junshi VV116 has been staying in July. Some investors asked on the interactive platform: VV116 has submitted two technical reviews, but it is regrettable whether the rumors that have not been approved are true? Junshi Biological responded publicly on July 14 that it was not real, and no progress has been disclosed since then.

Similarly, the pulpamine, which pioneered the pharmaceutical industry, did not have the following after the announcement of the clinical data of Phase III. In April of this year, the clinical data disclosed showed that Puklunamide had a 100%protection rate for new and high -age crown patients, but too dazzling data also encountered a lot of doubts.

The main business models of the new crown drugs at home and abroad are centralized government procurement. How big the market is on the prevention and control policies of different countries.

Foreign epidemic has not been effectively controlled, so the new crown drugs of Pfizer and Merck's enterprises have a large market; limited.

However, in the past two months, the new crown medicine has been approved to enter the clinic, which has also reflected the expectations of the regulatory authorities to a certain extent.

At the same time, compared to immune regulation special medicines for patients with severe illnesses, oral small molecular drugs are convenient and suitable for patients with minor symptoms. It is expected to become the mainstream drug, and the market size is considered to reach 100 billion yuan.

At present, Phaxlovid's Paxlovid and real creatures Azfding have been included in the emergency payment of medical insurance in various places. Even without considering expensive drug prices, the huge Chinese market cannot be satisfied by only two drugs.

Several drugs in the clinic are eager to join the war. In the end, who can seize the opportunity to be approved to be listed, it is necessary to rely on data and efficacy.

Writing | Li Ao

Edit ｜ Jiang Yun Jia Ting

Operation | Ren Jiahui

Illustration | Visual China

- END -