Innovative pharmaceutical companies "going to sea" should start from research and development
On January 25, Gilead Sciences announced that the US FDA has suspended clinical research in the company's mologliumab + azacitidine division. The FDA may suspect that the test produced unexpected adverse effects.
Molorizumab is a CD47 target drug, CD47 is considered by the industry to be another important target of anti-tumor drugs after PD-1, there is no product approved for marketing worldwide, with great commercial potential.
Domestic innovative pharmaceutical companies have been laid out on CD47 early, and the related products of Xinda Biology, Kangfang Biology and Tianjing Biology have entered the critical stage of research and development. Gilead's bad news quickly affected these businesses. The share price of Cinda Biologics, the fastest progressing CD47, has suffered consecutive declines, falling more than 26% in one week, and the stock price has hit a new low since April 2020, falling to HK$31.950.
Cinda has become a key target for the capital sell-off because as early as October 2018, its CD47 monoclonal antibody IBI188 has received clinical approval from the FDA and is currently conducting clinical research in the United States. The FDA's suspension of Gilead's clinical trials could signal a tightening of approvals for popular targets.
PREVIOUSLY FDA OFFICIALS HAVE PUBLICLY STATED THAT THE RAPID EXPANSION OF PD-1 IS "LARGELY UNCOORDINATED," LEADING TO MORE AND MORE PROBLEMS. Clearly, the FDA will not repeat the mistakes of PD-1, but will raise the approval threshold and clinical data requirements.
This poses a direct threat to the path of China's innovative pharmaceutical companies to the sea.
A large number of pharmaceutical companies followed the CD47, and Cinda also had PD-1 cards
CD47 is a widely expressed transmembrane glycoprotein with a well-defined therapeutic effect in the clinic. According to the incomplete statistics of the Health Bureau, in addition to the above-mentioned enterprises, pharmaceutical companies such as AbbVie, Hengrui Pharmaceutical, and Henlin Fuhong are also stepping up the development of drugs with CD47 targets.
Innovent's IBI188 development progress is at the forefront, and at the same time, another CD47/PD-L1 dual antibody of Innovent has also begun Phase I clinical research. It can be seen that whether it is a monoclonal antibody or a dual antibody product, CD47 is the focus of The future bet of Cinda Biologics.
At the 2020 Cancer Immunotherapy Society, Innovent Biologics published the results of a Phase 1a clinical study of CD47 monoclonal antibody in the United States for the treatment of advanced malignancies. Compared with Gilead Sciences, Innovent Biologics has done more dosage and safety exploration in Phase 1b clinical trials.
Analysts point out that Gilead Science's clinical trials are suspended or give latecomers a chance to be approved.
But the biggest problem of Cinda now is not whether there is a chance of approval, but that several large varieties declared in the United States have encountered embarrassment. This is the real reason why capital is not optimistic about the current situation of Cinda Biology.
Since the beginning of 2022, UBS has reduced the expected success of another blockbuster drug of Cinda Biologics, PD-1, in the United States from 100% to 75%, insisting that there is uncertainty about the listing of Cinda Biologics' cindili maclizumab in the United States.
On May 18, 2021, the FDA officially accepted the listing application of the PD-1 "Daboshu" jointly developed by Cinda Biologics and Eli Lilly. This is seen as an important step in the internationalization of Cinda Biotech. According to the process, March this year is the window period for the FDA to determine whether Cinda PD-1 is listed.
Although CITIC Securities pointed out that Cinda Biotech has been in communication with the FDA since filing the PD-1 listing application, and the deadline for finally deciding to list in March this year has not changed, this has not stopped the decline in Cinda's stock price.
The direction of FDA approval has changed, and innovative pharmaceutical companies have encountered difficulties in "going to sea"
The FDA's strict review may be the biggest black swan encountered by the biomedical industry since 2022.
As early as December 2021, the industry reported that the FDA would tighten the PD-1 approval standards. Dr. Pazduer, an FDA expert, said in an interview that it is problematic to rely on clinical data from one country alone to get a new drug approved for marketing, which runs counter to the FDA's advocacy of efforts to increase patient diversity in clinical trials.
Innovent has not yet published the number of countries in its own PD-1 clinical trials and cannot determine whether it meets the FDA's "patient diversity" requirements. But it is clear that Cinda will face more uncertainty about FDA approval.
When it comes to innovative pharmaceutical companies "going to sea", many people naturally think of opening up overseas sales channels. As everyone knows, if you want to seize the beach to land in the European and American markets, you must first carry out clinical trials on a larger scale and strive to complete the synchronous development of innovative drug products around the world.
According to the 2020 financial report of Cinda Biology, Cinda achieved a total income of 3.84 billion yuan for the whole year, a net loss of 1.00 billion yuan during the year, and a research and development investment of 1.58 billion yuan for the whole year, an increase of 43.0% year-on-year, mainly for the global development of priority products under development.
Cinda takes the BD approach to minimize its own expenses. Since 2013, Innovent Biologics has cooperated in product research and development, commercialization and other aspects, including MD Anderson Cancer Center, Roche Group, University of Zurich, Incyte, Microchip Bio and other first-line pharmaceutical companies or institutions at home and abroad.
Among them, the overseas commercialization authorization of PD-1 has brought certain positive benefits to Cinda. In November 2021, Xi Hao, CFO of Cinda Biologics, publicly stated: "Going international is the main reason for the decline in Cinda's loss in 2020." ”
But now, Innovent Biologics' PD-1 and CD47 blockbuster products may encounter obstacles in the United States. Changes in FDA's regulatory policy have become uncertain. Whether "internationalization" can still be promoted is very uncertain.
This is not only a problem for Cinda, but also a number of innovative domestic pharmaceutical companies that are aiming to develop overseas may face such a problem. Whether Xinda can survive the disaster safely, the Health Bureau will continue to pay attention.
Text | millet
Operational | Twenty-thirteen
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