2 线UC 早期疗效数据优秀，ILD 低发生率进一步验证BL-B01D1安全性。1）UC：2.2 mpk 剂量下，对于经过1 次化疗和IO 治疗的12例患者（100% PD-（L）1 经治，含铂化疗9 例，ADC 2 例，吉西他滨1 例），cORR 为75%，6 个月的PFS 率为100%；在全部的27 例患者（中位前线治疗线数2，52%接受过1-2 种ADC 治疗），ORR 为40.7%（cORR 为33.3%），DCR 为96.3%，6 个月的PFS 率为62.4%；未观察到ILD 发生。2）对于3L ESCC，52 例2.5mg/kg 剂量组人群，ORR为42.3%，DCR 为80.8%，mPFS 为5.0 个月，6 个月的OS 率为64.5%；≥3 级TRAE 发生率为53%，观察到1 例3 级ILD。3）对于3L BTC，21 例2.5mg/kg 剂量组人群，ORR 为28.6%，DCR 为76.2%。Incidents:
Recently, the company first announced the efficacy and safety data of EGFRxHER3 dual antibody ADCBL-B01D1 in urothelial cancer (UC), esophageal squamous cell carcinoma (ESCC), and biliary tract cancer (BTC) at 2024 ESMO. Among them, BL-B01D1 was selected for the 2024 ESMO Preferred Oral Report.
Opinions:
The early efficacy data for 2-line UC are excellent, and the low incidence of ILD further validates the safety of BL-B01D1. 1) UC: At 2.2 mpk dose, for 12 patients (100% PD- (L) 1, 9 platinum-containing chemotherapy, 2 ADC cases, 1 gemcitabine case), the CoRR was 75%, and the 6-month PFS rate was 100%; in all 27 patients (median frontline treatment line 2, 52% received 1-2 ADC treatments), ORR was 40.7% (CoRR was 33.3%), DCR was 96.3%, 6-month PFS The rate was 62.4%; no ILD occurrence was observed. 2) For 3L ESCC, 52 cases of 2.5 mg/kg dose group, ORR was 42.3%, DCR was 80.8%, MPFs were 5.0 months, and the 6-month OS rate was 64.5%; the incidence of grade 3 TRAE was 53%, and 1 case of grade 3 ILD was observed. 3) For 3L BTC, the ORR was 28.6% and the DCR was 76.2% for 21 people in the 2.5mg/kg dose group.
We believe that this data initially verifies that BL-B01D1 UC for platinum-containing chemotherapy and immunotherapy has a high response rate and good safety. There are about 0.1 million new cases of UC in China every year. Of these, about 20% have metastasized or progressed to an unresectable stage (LA/muc) when diagnosed. The frontline recommended treatment for LA/muc is platinum-containing chemotherapy or immunotherapy, and Nectin-4 ADC, HER2 ADC, etc. are recommended for post-line treatment. 2024 ESMO data showed that BL-B01D1 had a higher response rate than EV (CoRr 75% vs. 40.6%) for platinum-containing chemotherapy and immunoconvulsant patients. Furthermore, BL-B01D1 also showed a positive anti-tumor effect (ORR 40.7%) for a higher proportion of UC patients who received 1-2 ADC treatments at a later stage. In terms of safety, in 34 patients in the 2.2 mg/kg dose group, the incidence rate of grade 3 TRAE was 52.9%, and the discontinuation rate was 5.9%. No treatment-related deaths or ILD were observed.
Recently, the focus is on the December breast cancer data update, and BMS expects to launch the first overseas phase 3 in 2025. 1) Domestic progress. The company has launched 7 BL-B01D1 phase 3 clinical trials for multiple solid tumors in China, and is expected to complete phase 3 clinical trials for nasopharyngeal cancer or esophageal cancer in 2025 and submit a marketing application; 2) Overseas progress, the overseas phase 1 clinical trial of BL-B01D1 is progressing smoothly, and data is expected to be read out in 2025; in addition, BMS is expected to launch the first overseas registered phase 3 clinical trial in 2025; 3) Data catalysis: San Antonio Breast Cancer Symposium (SABCS, December 10-13) upper mammary gland Cancer data updates are worth watching.
Investment advice:
We used the DCF method and the NPV method for valuation, respectively, and calculated that the target market value was RMB 107.6 billion, and the corresponding stock price was RMB 268.33, maintaining a “buy” rating.
Risk warning
Innovative drug research and development falls short of expectations: there is a risk of not being able to successfully complete clinical drug development, obtain regulatory approval and commercialization in a timely manner; pharmaceutical industry policy changes risk: failure to adjust business strategies in a timely manner to adapt to changes in market rules and regulatory policies brought about by health care system reform will adversely affect the company's operations; macro-environmental risks: The company has R&D centers in China and the US, and the uncertainty of the future international political, economic and market environment may adversely affect the company's overseas business operations.
