ZL-1310 Ia期临床有效性和安全性表现优秀。据公司公告，本次公布的是正在进行的Ia部分单药治疗剂量递增数据，包括4 个剂量组（0.8mg/kg、1.6mg/kg、2.0mg/kg和2.4mg/kg）中25 位患者的安全性数据，以及19 位患者的有效性数据，入组患者中28%存在脑转移，56%此前至少接受过两种治疗，92%此前已接受PD-(L)1 治疗。有效性方面，ORR为74% (14/19)，其中脑转移患者中ORR为100% (6/6)，我们认为该ORR数据相比此前已公布其他ADC药物I期数据有小幅度提升，相比已上市的Tarlatamab（10mg亚组ORR 40%）提升更加明显，我们建议关注未来临床能否进一步验证OS水平的提升。安全性方面，在所有剂量水平下均具有良好的耐受性，3 级及以上TRAE发生率为40%（5/25），严重TRAE发生率为8%（2/25），且没有患者因TEAE而终止治疗，未出现细胞因子释放综合征（CRS），我们认为安全性数据表现优秀。基于该积极数据，公司将加速推进ZL-1310 单药用于2L+ ESSCLC的剂量扩展和1L联合疗法，并探索其他潜在适应症。The company's recent situation
On October 24, the company announced phase Ia clinical data on ZL-1310 (DLL3 ADC) treatment of second-line extensive small cell lung cancer (ES-SCLC) in oral form at the ENA conference.
reviews
ZL-1310 phase Ia has excellent clinical efficacy and safety. According to the company's announcement, dose escalation data for part Ia is currently being released, including safety data for 25 patients in 4 dose groups (0.8 mg/kg, 1.6 mg/kg, 2.0 mg/kg, and 2.4 mg/kg), and efficacy data for 19 patients. 28% of the enrolled patients had brain metastases, 56% had at least two treatments before, and 92% had previously received PD- (L) 1 treatment. In terms of efficacy, the ORR was 74% (14/19), of which the ORR was 100% (6/6) in patients with brain metastases. We believe that this ORR data is a slight increase compared to the previously published phase I data for other ADC drugs. Compared with the already marketed Tarlatamab (10mg subgroup ORR 40%) increase, we recommend focusing on whether future clinical trials can further verify the improvement in OS levels. In terms of safety, it was well tolerated at all dosage levels. The incidence of grade 3 and above TRAE was 40% (5/25), the incidence of severe TRAE was 8% (2/25), and no patients stopped treatment due to TEAE, and no cytokine release syndrome (CRS) occurred. We believe the safety data were excellent. Based on this positive data, the company will accelerate the promotion of ZL-1310 monotherapy for 2L+ ESSCLC dose expansion and 1L combination therapy, and explore other potential indications.
The company has entered the performance exchange period, and there are plenty of catalysts. The company's core product, Agamod, is used to treat myasthenia gravis. Since entering medical insurance in 2024, 1H24 contributed 36.4 million US dollars in revenue. The company expects its annual sales to reach 80 million US dollars, which is the main driving force for the company's performance growth; the NDA for another indication of agamod, chronic inflammatory demyelinating polyradiculoneuropathy, was also accepted by the CDE in May 2024. Karxt has been approved for listing by the FDA. The company is expected to release its key clinical data on registered sex bridging in China for the treatment of schizophrenia by the end of 2024, and commercialization will begin in 2026. The company anticipates that 2L+NSCLC indications for tumor electric field treatment will soon be submitted in China on 4Q24. Bemarituzumab has joined the 1L GC/GEJ Global Phase III FORTITUDE-102 study in China, and we expect it to release data in 2025.
Profit forecasting and valuation
We maintain the company's 2024 and 2025 earnings forecasts unchanged. We maintain our outperforming industry rating. Considering the positive data of ZL-1310, based on the DCF model, we raised the target price of H Shares/US Stocks by 27.4%/27.3% at HK$31.00/$40.00, which has 39.0%/38.2% upside compared to the current stock price.
risks
Approval and commercialization fell short of expectations, progress in reversing losses was slower than expected, and clinical data fell short of expectations.
