(1) Today, Hengrui Pharmaceutical announced that it will submit a marketing application for camrelizumab in the United States again, having previously received a CRL issued by the United States FDA, resulting in delays;

(2) Junshi Biosciences' PD-1 variety has also suffered delays in the United States, but it has been successfully listed, and the industry says that Hengrui may replicate this process;

(3) If it is successfully listed in the United States, it will be of great significance to Hengrui Pharmaceutical's internationalization strategy.

In the face of thousands of announcements of listed companies every day, what should I read? What is the point of the announcement of major events, which is often dozens of pages and hundreds of pages? There are a bunch of professional terms in the announcement, I don't know if it's good or bad? Please take a look at the "Speed Reading Announcement" column of the News Department of the Financial Associated Press, and our reporters stationed all over the country will bring you accurate, fast and professional interpretation on the night of the announcement.

Finance Associated Press, October 15 (Reporter Lu Afeng) The determination of the innovative drug "First Brother" to promote the listing of camrelizumab in the United States is very firm, and it has only been five months since the receipt of CRL that led to 600276 the failure of the first marketing application. SH) has submitted another application for camrelizumab in the United States.

Hengrui Pharmaceutical announced this evening that the company received a confirmation letter from the United States Food and Drug Administration (hereinafter referred to as the "FDA"), and the company's resubmitted biologics license application (BLA) for camrelizumab for injection combined with apatinib mesylate tablets for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma was accepted by the FDA.

An industry expert told the Financial Associated Press reporter that Hengrui Pharmaceutical's camrelizumab in the United States seems to have signs of replicating Junshi Biosciences' toripalimab, "If camrelizumab can be successfully marketed in the United States, Hengrui Pharmaceutical's international development will reach a new level." ”

There have been procedural delays before

According

to the Prescription Drug User Payments Act (PDUFA), the FDA's target review date for injectable camrelizumab is March 23, 2025.

This is the second time that Hengrui Pharmaceutical has submitted a marketing application for camrelizumab in the United States, and the first submission and acceptance will be in July 2023. However, in May 2024, HLB-LS, the parent company of Elevar Therapeutics, the exclusive global licensee for the development and commercialization of camrelizumab in liver cancer outside of Greater China and Korea, received a full response letter (CRL) from the FDA regarding the New Drug Application (NDA) for camrelizumab in combination with apatinib in patients with first-line unresectable hepatocellular carcinoma.

The FDA emphasizes two main elements in the CRL: one is chemistry, manufacturing and control (CMC) issues; Second, FDA inspections of key clinical trial centers in Russia and Ukraine have not yet been completed. This means that the procedure for Hengrui PD-1 combination therapy to be marketed in the United States has been delayed.

Some industry experts told the Financial Associated Press reporter that CRL is equivalent to putting forward the place or measure that needs to be rectified, on the other hand, it shows that the research and development of the therapy has been relatively standardized, close to or has met the relevant requirements, theoretically speaking, Hengrui can re-submit the listing application after completing the rectification within the specified time.

Yang Tao, a senior pharmaceutical industry expert, told the Financial Associated Press reporter today that there are few political considerations in the field of United States new drug registration, especially the product categories with relatively mature technology such as monoclonal antibodies, and many problems have been found in China and India companies in the past, "United States it is not meaningful for the FDA to deliberately make things difficult." ”

Will Junshi PD-1 be replicated in the U.S.?

The reporter of the Financial Associated Press noticed that the PD-1 product of Junshi Biosciences-you (688180.SH) had also received CRL in the process of applying for listing in the United States.

According to public information, in May 2022, Junshi Biosciences' marketing application for toripalimab received a CRL from the FDA, and the FDA requested a change in the quality control process, which Junshi Biosciences believes is easier to implement. In July 2022, Junshi Biosciences resubmitted the marketing application for toripalimab, which was accepted by the FDA, and finally officially approved by the FDA in October 2023.

Regarding the listing process of Hengrui Pharmaceutical in the United States, it seems that the approval process of Junshi Biosciences' toripalimab is being replicated, and some industry experts told the Financial Associated Press reporter, "It is indeed a bit similar, it depends on the result." ”

However, Yang Tao said that there is still a little difference between the two, "It can indeed be reproduced, but literally, the defects of Hengrui Pharmaceutical are difficult to change compared with Junshi Biosciences." ”

It is worth noting that in addition to the above-mentioned CRL, Hengrui Pharmaceutical also received Form 483, a common document for inspection, issued by the US FDA in June this year. Hengrui Pharmaceutical said that the 483 form received this time does not involve the production site involved in the application for the combination of carrelizumab and apatinib, and the company's exports to United States preparations have not been affected.

Yang Tao told the Financial Associated Press reporter that although camrelizumab has been approved for a number of indications in China, the difference between the volume of the domestic market and the international market is obvious, and if its PD-1 variety is approved in the United States, Hengrui Pharmaceutical's international development strategy can be said to have reached a new level.

Hengrui Pharmaceutical also reminded in the announcement that a number of PD-1 monoclonal antibodies have been approved for marketing abroad, including pembrolizumab (Merck), dostarlimab (GlaxoSmithKline), etc., and a number of similar products have been approved for marketing in China, with a total global sales of anti-PD-1 antibodies in 2023 of about 37.592 billion US dollars. Due to the uncertainty of the timing and results of the FDA's on-site inspection, there is uncertainty about whether the BLA will be approved. Collection

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