The first-line treatment for NSCLC has been approved for market launch, bullish on survival benefit potential, maintaining a 'Shareholding' rating.
According to the Zhito Finance APP, Guotai Haitong issued a Research Report stating to maintain a $AKESO (09926.HK)$ “Shareholding” rating. The company's core products have achieved consecutive clinical breakthroughs and have entered a harvest period, maintaining revenue forecasts for 2025-2027 at 3.728/5.928/7.8 billion yuan, adopting the PS valuation method, giving a 28X PS for 2025, corresponding to a Target Price of 123.72 HKD (originally 128.14 HKD).
The main points of Guotai Junan are as follows:
Evofosfamide has been approved for first-line treatment of NSCLC indications.
According to a disclosure on the company's WeChat public account on April 25, Evofosfamide monotherapy for PD-L1 positive (TPS≥1%) NSCLC first-line treatment has been approved by NMPA for market launch. Evofosfamide is the first drug in the world to show significant positive results in head-to-head III phase clinical research against the "King of Drugs" Pembrolizumab, providing a new, more efficient, and safer "non-chemotherapy" option for first-line NSCLC treatment. As of now, Evofosfamide has achieved significant positive results in three III phase studies in the lung cancer field, including Evofosfamide treatment for EGFR-TKI progressing NSCLC, Evofosfamide compared to Pembrolizumab for first-line treatment of PD-L1 positive NSCLC, and Evofosfamide combined with chemotherapy compared to Toripalimab combined with chemotherapy for first-line treatment of sq-NSCLC, where the latter two were III phase studies comparing the Evofosfamide regimen to the current best SOC (PD-1 therapy).
Bullish on Evofosfamide's survival benefit potential.
In the ITT population, the mPFS for the Evofosfamide group and the Pembrolizumab group was 11.14 vs 5.82 months, PFS HR=0.51 (P<0.0001); the interim analysis of mOS conducted at 39% maturity (with an alpha allocation value of only 0.0001) showed that Evofosfamide compared to Pembrolizumab has significant clinical survival benefits, HR=0.777, reducing the risk of death by 22.3%. It is believed that Evofosfamide has initially demonstrated excellent survival benefit potential, and considering the low maturity of this data analysis and the small alpha allocation value, the statistical benefits of Evofosfamide's survival benefits remain to be observed in subsequent tracking.
The overseas lung cancer layout continues to advance.
Abroad, the company, in collaboration with its partner Summit, is leading the Phase III registered clinical trials, including: a comparison of chemotherapy treatment with third-generation EGFR-TKI for nsq-NSCLC, an international multicenter Phase III study comparing combination chemotherapy with pembrolizumab plus chemotherapy as first-line treatment for squamous and non-squamous NSCLC, and a comparison of pembrolizumab as first-line treatment for PD-L1 high-expressing NSCLC. The clinical layout continues to advance.
Risk factors: uncertainties in new drug development; risks of commercialization progress falling short of expectations.
Editor/Lee