With the continuous improvement of the innovation and research and development capabilities of domestic pharmaceutical companies, domestic new drugs are accelerating to the sea
.
Recently, Lee's Pharmaceuticals announced on the Hong Kong Stock Exchange that the investigational new drug candidate and drug AU409 manufactured by Zhaoke Pharmaceutical (Guangzhou) Co.
, Ltd.
, a wholly-owned subsidiary of the company, has been approved by the US Food and Drug Administration for clinical trials, targeting patients
with advanced primary liver cancer or advanced solid tumor liver metastases in the United States.
According to the data, AU409 is a novel compound discovered and developed by Auransa Inc.
, and its formulation is developed by Zhaoke Guangzhou at its facility in Nansha District, Guangzhou City, and manufactured
in accordance with good manufacturing practices issued by the USFDA.
The approved clinical trial will be the first to
be conducted in humans.
Lee's Pharmaceuticals is also applying for a Phase I clinical trial in collaboration with Dr.
Chiang Chi Leung of the University of Hong Kong for the use of AU409
in patients with advanced hepatocellular carcinoma who have been refractory to standard first-line treatment in Hong Kong.
Auransa is now planning a separate clinical trial
in the United States.
Prior to this, Shutaishen also issued an announcement that the company received a notice from the US Food and Drug Administration (FDA) to accept the new drug clinical trial application
of STSA-1002 subcutaneous injection for ANCA-associated vasculitis indications.
It is reported that STSA-1002 is a recombinant anti-human C5aIgG1 fully human monoclonal antibody targeting C5a, which specifically binds to allergic toxin C5a, makes C5a lose the ability to bind receptors, blocks C5a-induced biological functions, such as neutrophil chemotaxis, degranulation and oxygen respiration bursts, etc.
, while not affecting the formation of C5 cleavage and membrane attack complex (MAC), retaining the lytic and bactericidal functions
of the complement system.
In addition to the above drugs, since the beginning of this year, there have been a number of developments regarding the acceptance of domestic new drug clinical trial applications by the US FDA, including cedarchicel, which is used to treat relapsed/refractory multiple myeloma (MM) in adults, the first cell therapy product approved by the FDA in China, and the world's second CAR-T cell immunotherapy approved to target BCMA
.
The industry believes that the continuous acceleration of new drugs of domestic pharmaceutical companies to the sea fully shows that the strength of domestic new drugs is constantly rising
.
In order to cope with the intensification of competition in the pharmaceutical market, the pressure of price reduction brought by domestic centralized procurement, and the continuous squeeze of the return space after the launch of innovative drugs, many domestic local innovative pharmaceutical companies with strength have already accelerated the international layout
of new drugs.
For example, on September 26, Frontier Biotech mentioned at the performance statement meeting that Ekonin has obtained the marketing authorization of Malaysian drugs and submitted drug registration applications
in 7 countries.
The company said that in the future, it will continue to actively promote the commercialization process of Ekonin overseas in close connection with the business plan formulated to achieve the overseas business income
of Ekonin.
On September 27, Legend Biotech announced that Japan's Ministry of Health, Labor and Welfare (MHLW) has approved CARVYKTI® (Ciltacabtagene Autoleucel, abbreviated as Cilta-cel) for the treatment of adult patients
with relapsed or refractory multiple myeloma (R/R MM).
In general, while the research and development capabilities of domestic new drugs have achieved rapid development, they have also begun to play an increasingly important role
in the global pharmaceutical innovation map.
The industry expects that in the next 5~10 years, with the advancement of domestic enterprise technology and the advancement of existing product research and development and clinical progress, more domestic drugs will be listed overseas and create a new revenue growth curve
.
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