Zhongtong Finance APP learned that Bocom Intl has issued a research report, reiterating a 'buy' rating on Akeso, believing that now is still an excellent layout opportunity, with a target price of HKD 70, and will continue to choose Akeso as one of the industry's top recommended symbols. The clinical results of HARMONi-2 meet the bank's expectations and are a further verification of the clinical treatment of AK112 and its potential in the global market. The bank will continue to focus on the disclosure of detailed data in September and subsequent updates to OS data.

The company announced that the III clinical trial (AK112-303/HARMONi-2) of AK112 head-to-head treatment with Keytruda for PD-L1 positive NSCLC has achieved a decisive positive result. Compared with Keytruda, AK112 can significantly prolong patient PFS, and the HR is significantly better than expected (specific values not yet announced, the bank expects to be below 0.7). Specific data will be released at the WCLC conference in September. Keytruda's global sales in 2023 will reach $25 billion, of which the bank estimates that more than half will come from various types of lung cancer indications and is the preferred drug for frontline treatment of PD-L1+NSCLC in various guidelines. AK112 has become the first drug in the world to prove survival benefit improvement in Phase III single-agent head-to-head clinical trials. Subgroup analysis showed that PFS benefits were significant in both PD-L1 high expression (TPS≥50%) and PD-L1 medium-high expression (TPS1-49%) populations, and the HR values were close. Other subgroup analyses also showed strong positive efficacy results, including squamous/non-squamous, with/without liver metastases, with/without brain metastases. The company expects to submit a supplementary application for a new indication to the National Medical Products Administration soon. Previously, AK112's marketing application for EGFR-TKI-resistant NSCLC has been approved by the National Medical Products Administration and was first shipped on May 30.

The bank's interpretation - the guiding significance of PFS efficacy on OS: after obtaining a positive result for PFS, the market's core focus shifted to OS. Although existing PFS data is limited, the bank holds a cautious and optimistic attitude towards OS results. 1) According to the results of a study on the correlation between surrogate endpoints and OS, the correlation coefficient between PFS and OSHR after PD-(L)1 monotherapy in PD-L1+NSCLC patients reached 0.80. If the PFSHR of HARMONi-2 is less than 0.7, the bank speculates that the OSHR may be lower than 0.65, but the control group of PD-(L)1 monotherapy itself brings some uncertainty to this speculation. 2) The Phase III LEAP-007 trial (K drug+lumbewa vs. K drug monotherapy for PD-L1+NSCLC) achieved a PFSHR of 0.78 and verified the extended effect of inhibiting the VEGF pathway on survival benefit, but the treatment group's higher toxicity (3-5 grade TRAE incidence rate of 58%) to some extent affected the final OS result (HR1.10); the safety of AK112 in Phase II trials is significantly better (3-5 grade TRAE22%).