Economic Observer reporter Qu Yixian On the evening of May 2, two innovative pharmaceutical companies, Junshi Bio (01877.HK), Chi-Med Pharmaceuticals (00013.HK) both announced that they had received a complete reply letter from the U.S. Food and Drug Administration (FDA) for one product of their respective companies, and the marketing applications for both products were unsuccessful, but the reasons given by the FDA were not. Same.
For the biologics license application submitted by Junshi Bio for PD-1 product toripalimab for the treatment of nasopharyngeal carcinoma, the FDA requested a quality control process change, Entity believes this change is easier to accomplish.
Junshi also said it plans to meet directly with the FDA and expects to resubmit its marketing application by mid-summer 2022.
It is worth noting that the FDA’s reply letter to Junshi Biotech mentioned that the pending on-site inspection was hampered by travel restrictions related to the novel coronavirus pneumonia epidemic. The verification time will be notified separately.
Compared with Junshi Bio, Chi-Med’s new drug application for surufatinib for the treatment of pancreatic and non-pancreatic neuroendocrine tumors is facing a more severe situation.
FDA believes that the current data package based on two successful Phase III studies in China and a bridging study in the United States is insufficient to support the current approval of the drug in the United States. The full response letter states that more international multicenter clinical trials (MRCTs) representing the U.S. patient population are needed to support U.S. approval.
This is similar to the situation in which Sintilimab of Innovent Bio (01801.HK) passed through the FDA not long ago. The ORIENT-11 study that sintilimab was used for marketing was only conducted in the Chinese population, and FDA experts questioned whether it was applicable to American patients. The FDA also recommends that Innovent supplement additional clinical trials to demonstrate the applicability of sintilimab in the U.S. population and in U.S. medical practice.
Surufatinib is an oral inhibitor with dual anti-angiogenic and immunomodulatory activities. Its safety and efficacy have been evaluated in two Chinese advanced pancreatic and non-pancreatic treatments. Demonstrated in randomized, double-blind, phase III studies (i.e., SANET-ep and SANET-p studies) in patients with neuroendocrine tumors.
A bridging study sponsored by Chi-Med and conducted in the United States also showed similar safety and efficacy to the two SANET study populations. Surufatinib was approved in China in June 2021 and December 2020 for the treatment of pancreatic neuroendocrine tumors and non-pancreatic neuroendocrine tumors, respectively.
Surufatinib was granted Fast Track designation by the U.S. FDA in April 2020 for the treatment of pancreatic and non-pancreatic neuroendocrine tumors, and was granted orphan designation in November 2019 Eligibility for the treatment of pancreatic neuroendocrine tumors.
Chi-Med Pharmaceuticals stated that in May 2020, Chi-Med Medicine reached an agreement with the FDA at the pre-marketing meeting for surufatinib for the treatment of pancreatic and non-pancreatic nerves Two Chinese Phase III studies with positive results in patients with endocrine tumors, together with existing data from the U.S. bridging study of surufatinib, may form the basis for an NDA submission in the U.S. The FDA accepted an NDA for surufatinib in June 2021.
According to Chi-Med’s announcement, the FDA assessed the applicability of data from two SANET studies from a single country to U.S. patients and U.S. medical practice. The full response letter states that the FDA will require an international multicenter clinical trial that incorporates a more representative U.S. patient population and is consistent with current U.S. medical practice. In addition, on-site inspections and scheduling related to the outbreak are also one of the reasons for the FDA’s action. The FDA’s move is not related to any safety concerns with surufatinib. Chi-Med is working with the FDA to evaluate next steps.
If the clinical trial is supplemented, Chi-Med needs to invest time, manpower and material resources on surufatinib again.
Chi-Med CEO and Chief Scientific Officer Su Weiguo said the FDA’s decision was disappointing, but his company will continue to actively cooperate with U.S. authorities to assess its feedback. Chi-Med maintains transparency and cooperates with FDA throughout the review process of U.S. marketing applications.