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信达生物(01801.HK):肿瘤管线积极数据披露 慢病品种销售即将兑现

Cinda Biotech (01801.HK): Oncology Pipeline Actively Discloses Sales of Chronic Disease Varieties Will Soon Be Fulfilled

中金公司 ·  Jun 17

The company's recent situation

The company recently disclosed positive data on three tumor pipeline products at the 2024 ASCO conference and ESMO Plenary. The clinical data actively read out the superposition company's efficient clinical promotion strategy. We believe that the company's tumor pipeline is expected to continue to be enriched, and it is recommended to pay attention to further data disclosure of cancer products such as IBI363 in the future.

reviews

Clinical data on early small samples of IBI363 (PD-1/IL2 double fusion protein) is positive, focusing on the future treatment potential of the product for patients with IO-treated solid tumors. The IBI363 phase Ia/Ib study was announced. As of April 16, 24, there were 347 participants (including 100 NSCLC cases, 89 cases of melanoma, 102 CRC patients and other solid tumor patients). The patients were treated with different doses of 0.2 μg/kg QW-3 mg/kg Q3W. The dose escalation phase IBI363 showed a positive response to initial treatment results in NSCLC, melanoma, and colorectal cancer. Among them, the data on 9 high-dose lung cancer patients is worth paying attention to. Among them, 8 had previously received PD- (L) 1 treatment, 1 had TCE treatment, patients received 3 mg/kg Q3W, and 6 cases of lung squamous cell carcinoma had an ORR of 100%. We believe that high-dose group data is worth paying attention to in the early stages of SqnsCLC. The company expects to further explore the potential of IBI363 as a single agent in the post-treatment of lung cancer and melanoma, and will also explore the further therapeutic potential of IBI363 combined with ADC products. It is recommended to pay attention to IBI363's subsequent clinical development trends and data reading pace.

CLDN18.2 dual antibodies and the ADC products IBI389 & IBI343 are being promoted clinically efficiently, and PDAC has shown positive therapeutic potential. IBI343 is currently undergoing global phase III clinical trials for CLDN18.2-positive and HER2-negative MGC/GEJ as a single agent. At this ASCO conference, the company announced initial phase I data for IBI343 pancreatic cancer patients treated with at least first-line treatment. The results showed that among 10 patients receiving 6mg/kg of CLDN18.2 with medium to high expression (IHC1/2/3 + ≥ 60%), ORR was 40%.

Currently, the FDA has granted IBI343 fast-track status for CLDN18.2-positive advanced pancreatic ductal adenocarcinoma. We believe that treatment for patients with advanced pancreatic cancer is still mainly based on systemic chemotherapy. Early IBI343 data has potential, and it is recommended to actively pay attention to further data readings. In addition, the CD3/CLDN18.2 dual antibody IBI389 also showed a positive data response in pancreatic cancer and gastric cancer in the early stages. We expect IBI389 & IBI343 to form a combination for pancreatic cancer and gastric cancer in the future.

Follow the report's loss reduction expectations and the pace of product sales volume. In '23, Cinda Biotech's three fees were well controlled. R&D expenses fell 22% year on year, management expenses fell 10% year on year, sales and marketing expenses were reduced by 6.9 percentage points compared to '22, and product-side revenue increased steadily. We expect the company will start to cash in revenue from various chronic disease products in '25. It is recommended to actively pay attention to positive trends on the company's reporting side.

Profit forecasting and valuation

We kept our 24/25 revenue and profit forecast unchanged, and maintained an outperforming industry rating. Based on the DCF model, due to the continuous implementation of the company's pipeline clinical data, we believe that the pipeline value potential will increase, and the target price will increase by 4.2% to HK$50 (30.5% upward space).

risks

Pipeline progress fell short of expectations; commercialization fell short of expectations; product price reductions exceeded expectations.

The translation is provided by third-party software.


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