According to Zhitong Finance APP, GF SEC released a research report maintaining a "Buy" rating for Hutchmed (China) (00013), expecting Net income to be 0.005, 0.02, and 0.074 billion USD for 2024-2026, with a reasonable value of 41.35 HKD/share obtained through DCF method. The company's R&D, commercialization, and overseas capabilities have been initially validated, with a sufficient pipeline of differentiated innovations. As various products gradually enter the harvest period.

The main points of GF SEC are as follows:

Event:

Hutchmed (China) announced that the new drug application for the combination therapy of Ayutuz (Furmonertinib) and Dabulizumab (Sintilimab injection) for treating patients with advanced mismatch repair-deficient (pMMR) endometrial cancer who have failed previous systemic antitumor therapy and are unsuitable for radical surgical treatment or radical radiotherapy has been conditionally approved in China. Previously, this combination therapy was included in priority review and breakthrough therapy by the National Medical Products Administration.

There remains a significant unmet need in the field of endometrial cancer, and the combination of Furmonertinib and Sintilimab is expected to become a more effective option for this indication.

According to the announcement, this approval is supported by data from the FRUSICA-1 study during the registration phase. The data from this study will be presented at the ASCO annual meeting in June 2024. The study results show that in patients with endometrial cancer who had disease recurrence, progression, or intolerable toxicity after platinum-based doublet chemotherapy, the ORR of the combination of Furmonertinib and Sintilimab reached 35.6%, with a DCR of 88.5%. This combination therapy acts quickly, with a median time to disease remission of only 1.6 months, mPFS of 9.5 months, and mOS of 21.3 months. Additionally, the adverse events reported are consistent with those of similar immunotherapy combination anti-angiogenesis treatments, demonstrating excellent efficacy and controllable safety.

The combination therapy of Furmonertinib and immune checkpoint inhibitors has been validated for the first time, expected to open new incremental space.

This approval verifies the therapeutic potential of Furmonertinib in combination with other Pharmaceuticals, especially immune checkpoint inhibitors. According to the company's official website, in addition to the already approved indication for endometrial cancer, Furmonertinib currently has several combination therapies with immune checkpoint inhibitors in clinical stages, among which the fastest progressing is the combination with Sintilimab for the treatment of renal cell carcinoma, and the registration trial is nearing completion.

Risk warning: pharmaceutical review risks, cost control policy risks, research and development progress not meeting expectations.