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信达生物(01801.HK):多项会议积极数据披露 慢病品种销售即将兑现

Cinda Biotech (01801.HK): Multiple Conferences Actively Disclose Data, Sales of Chronic Disease Varieties Will Soon Be Implemented

中金公司 ·  Jun 26

The company's recent situation

The company recently disclosed positive data on three tumor pipeline products at the 2024 ASCO Conference and ESMO Plenary; in addition, the GLP-1R/GCGR dual agonist Mastopeptide revealed the results of the world's first phase III weight loss clinical (GLORY-1) study at the 24th ADA conference.

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 (100 NSCLC cases, 89 cases of melanoma, 102 patients with CRC and other solid tumors). The patients were treated with different doses of 0.2 μg/kg QW-3 mg/kg Q3W. During the dose escalation phase, IBI363 showed a positive response to initial treatment results in NSCLC, melanoma, and colorectal cancer. Nine patients received 3 mg/kg Q3W, including 6 patients with 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 explore the further therapeutic potential of IBI363 combined with ADC and other products. Furthermore, 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 a phase III study of CLDN18.2-positive and HER2-negative MGC/GEJ as a single agent. We believe that Cinda Biotech's oncology pipeline layout is gradually being perfected, and that clinical data is actively reading out the superposition company's efficient clinical promotion strategies. We recommend focusing on future data disclosure of cancer products such as IBI363.

GLORY-1 studies have shown excellent weight loss efficacy and potential clinical liver benefits with Maxidol peptides. The phase III clinical results of GLORY-1 at the 24th ADA Conference showed that after 48 weeks of treatment, the average body weight of Mashidopeptide 6 mg was reduced by 14.3% compared to placebo, and after long-term treatment, the liver fat content of the vast majority of patients decreased significantly; cardiovascular metabolic risk indicators decreased significantly. At week 48, the patient's waist circumference, systolic blood triglycerides, total cholesterol, LDL-C, blood uric acid, and ALT were superior to placebo. Currently, Mashidu Peptide has been accepted by CDE for weight loss. We expect Maxidu Peptide to become the first domestically approved dual-target GLP1 drug.

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 basically 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 has increased, and the target price will increase by 20.8% to HK$58 (46.8% 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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