Core ideas:
Event: recently released the "announcement on the voluntary disclosure of the main clinical trial data of the BL-B01D1 (EGFR × HER3 anti-ADC) project for the extended phase of Ib indications for locally advanced or metastatic nasopharyngeal carcinoma". As of March 10, 27 NPC subjects had been evaluated at least once under all effective doses, with a median therapeutic line of 3 lines, an objective remission rate (ORR) of 55.6% and a disease control rate (DCR) of 100%. MPFS has not been reached Among them, under the recommended dose of II phase (RP2D) 2.5mg/kg D1D8 Q3W, there were 17 patients with nasopharyngeal carcinoma who had at least one curative effect evaluation. the median meridian line was 3 lines, and their ORR was 58.8% (10 SD 17), DCR was 100% (all SD were tumor shrinking SD), and mPFS had not yet been reached. Among them, 4 subjects whose first swelling was rated as SD (reduced by 18%-26%) significantly reduced the number of drug use due to the COVID-19 epidemic (the actual / theoretical drug use times were: 0max 8, 0max 8, 1max 8, 4max 8, respectively), resulting in tumor enlargement or PD out of the group or shedding.
In stage I clinic, many kinds of tumors showed curative effect signals. BL-B01D1 received the notice of approval for Drug Clinical Trials issued by NMPA on October 18, 2021. At present, BL-B01D1 has carried out 5 Ia/Ib clinical studies, covering 16 kinds of tumors. At present, more than 200 patients with 12 kinds of tumors have been enrolled in the group. tumor evaluation data show that BL-B01D1 has a strong effective signal in all 12 kinds of tumors and has good safety under the recommended dose of II phase (RP2D).
B01D1 may have a unique MOA and is expected to become a large variety in the world. The cooperation of BL-B01D1 dual targets and the new generation of linker and payload technologies may produce unique MOA. Among them, non-small cell lung cancer has shown a breakthrough effect that can communicate with CDE and advance to registered clinic. In advanced nasopharyngeal carcinoma or metastatic nasopharyngeal carcinoma, it also shows a breakthrough effect that can communicate with CDE and advance to registered clinic.
Profit forecast and investment advice. It is estimated that the EPS in 22-24 will be-0.67,0.74 and-0.82 yuan per share respectively, and the reasonable value of the company will be maintained at 77.01 yuan per share and the "buy" rating will be maintained.
Risk tips: product research and development is not as expected, commercialization is not as expected, overseas development failure and so on.