The company's recent situation

Recently, in 2024, the American Society of Clinical Oncology (ASCO) announced positive clinical results of Trop2 ADCSKB264; on May 20, our partner MSD launched SKB264's 9th global phase III clinical trial to maintain first-line squamous NSCLC in combination with Keytruda. 1 comment

According to recent data disclosed by Trop2 ADC around the world, we believe that Trop2 ADC combined with IO first-line treatment for NSCLC is becoming more definitive, and SKB264 is expected to impact the first-line NSCLC market. At this ASCO conference, the company announced the phase II results of SKB264 combined with PD-L1 monoclonal antibody KL-A167 (optiTrop-Lung01). The patients in the two cohorts received SKB264 and KL-A167 with different dosing cycles, 1A cohort (n=40), with a median follow-up time of 14.0m, ORR 48.6%, and mPFS 15.4m. The 1B cohort (n=63), median follow-up time of 6.9m, ORR 77.6%, did not reach median PFS. We believe that the small sample data released this time showed a positive response to first-line wild-type NSCLC, with significant non-head-to-head benefits compared to current standard treatments. In addition, at this ASCO conference, Trop2 ADC competitors Dato-DXD (AstraZeneca/Daiichi Sankyo) and Trodelvy (Gilead) also read positive data from first-line NSCLC. We determined that Trop2 ADC has market potential, and that the current SKB264 data has an advantage in the competition. We recommend that we actively pay attention to subsequent large sample size data readings. On May 20, partner MSD launched a first-line NSCLCIII clinical trial. We recommend focusing on future phase III clinical data readings led by MSD globally.

SKB264 TNBC backline positive data were read, and clinical strategies for TNBC at home and abroad differ according to the market value of the indications. At this ASCO conference, SKB264 published positive phase III data for TNBC after monotherapy. The results showed that compared with chemotherapy in the control group, MPFs treated with SKB264 as a single agent were effectively prolonged by 3.4 months, confirming the positive therapeutic efficacy of SKB264 in TNBC. The company expects SKB264 later-line treatment TNBC to be approved for listing in 2H24. Columbotai is currently carrying out a domestic phase III clinical trial of SKB264 single-agent first-line PD-L1 negative TNBC, and overseas MSD has launched a global phase III clinical trial of MK2870 combined with K drugs as a new adjuvant treatment for TNBC.

A variety of products are expected to be launched within the year, and Colombotai will soon enter a commercial cashout period domestically. A166, cetuxime bioanalogs, and SKB264 are expected to be approved for listing in 2H24/1H25. According to the company's disclosure, it is expected that a 400-500 person oncology commercialization team will be set up in the short term to be responsible for the marketing and sale of various domestic products. We recommend focusing on the commercialization of the company's future products after they are launched.

Profit forecasting and valuation

We kept our revenue and profit forecasts unchanged for 24 and 25, maintained an outperforming industry rating, and maintained a target price of HK$210 (19.4% upside) based on the DCF model.

risks

Sales of new drugs fell short of expectations; research and development of new drugs fell short of expectations; progress in overseas cooperation fell short of expectations.