The export of domestic PD-1 is much more difficult than expected. On December 23, Junshi Biosciences failed to get the FDA's reply letter on the Biologics License Application (BLA) of its PD-1 product - Toripalimab Injection as expected, which means that the FDA's relevant approval process was postponed again.
In March last year, Junshi Biosciences announced to submit the rolling marketing application to FDA about the Toripalimab for the treatment of recurrent or metastatic nasopharyngeal carcinoma, becoming the first domestic PD-1 antibody drug to submit the marketing application to FDA. In May, Junshi Biosciences announced to receive a complete reply letter from FDA about the BLA of the use of Toripalimab combined with gemcitabine/cisplatin as the first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma, and the use of the single-drug as the second-line or above treatment of recurrent or metastatic nasopharyngeal carcinoma after platinum-based treatment.
According to the letter, a change in the quality control process was needed before the official approval of Toripalimab. However, due to the travel restrictions related to COVID-19, the required on-site verification could not be completed in China as scheduled. Therefore, the review time of application for the marketing license of Tislelizumab would be extended until the on-site verification was completed.
In July 2022, TopAlliance announced that FDA had accepted the BLA application of Toripalimab and set the target review date of the Prescription Drug User Fee Act (PDUFA) as December 23, 2022. That is, the approval of the marketing application of Junshi Biosciences's PD-1 monoclonal antibody was determined before this date.
In fact, Toripalimab is the first anti-PD-1 monoclonal antibody approved for the treatment of nasopharyngeal carcinoma in the world. FDA has not approved to use any tumor immunotherapy for the treatment of nasopharyngeal carcinoma. Therefore, there are high hopes for the marketing of Junshi Biosciences's Toripalimab in the United States.
However, under the attention of the industry, the FDA postponed the approval again. On December 24, Junshi Biosciences announced that: they failed to get the FDA's reply letter on this BLA application of Toripalimab, which means that the expected result was not achieved on the original target review date, i.e. December 23. This is FDA's another postponement to the BLA application process for Toripalimab.
Because of the Difficulties in the United States, TopAlliance Turns to the Middle East and North Africa
According to the financial report of TopAlliance in 2021, the sales volume of Toripalimab was only RMB 412 million, which decreased by nearly 60% year-on-year, and was one of the worst performances among the domestic PD-1 disclosed. In the first three quarters of 2022, the sales volume of Toripalimab increased to RMB 516 million, but it was still at the bottom of the four main PD-1s. Because of the poor sales volume in China, the "Export" of TopAlliance is imperative.
This time, TopAlliance turns to the Middle East and North Africa. On December 25, Junshi Biosciences issued an announcement: it has signed the Exclusive License and Commercialization Agreement with Hikma, a company listed on the London Stock Exchange, which grants Hikma the exclusive license to develop and commercialize Toripalimab injection in 20 countries in the Middle East and North Africa, including Jordan, Saudi Arabia, the United Arab Emirates, Qatar, Morocco, Egypt, etc. In addition, it can get a total payment of up to US$ 12 million, plus a ladder sharing of nearly 20% of net sales.
Hikma was founded in 1978. After more than 40 years of development, now it has 31 pharmaceutical factories and 7 R&D centers in more than 50 countries in the world, with nearly 10,000 employees, and its products involve the drugs for anti-infection, cardiovascular disease, central nervous system disease, diabetes, tumor,...
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