Core views

The company updated IBI363 efficacy data on NSCLC and CRC at the WCLC and ESMO conferences respectively. Overall, the safety of IBI363 was excellent in both indications. At the same time, IBI363 showed breakthrough efficacy in sqnsCLC. Among 29 patients treated in the 3mg/kg dose group, the overall ORR was 34.5% and the DCR was 89.7%; in patients with at least 12 weeks of follow-up in the 3mg/kg dose group or who had completed the study, the ORR of 18 patients was 50% and the DCR was 88.9%. The early ORR and DCR effects of the product were impressive, and the low dose MPFs The data is also excellent. We believe that IBI363 has both excellent efficacy and safety, and is expected to become the second-generation IO leading drug.

occurrences

On September 9, Cinda Biotech announced stage I colorectal cancer data at IBI363 (PD-1/IL2α) at the ESMO conference.

On September 11, Cinda Biotech updated stage I non-small cell lung cancer data on IBI363 (PD-1/IL2α) at WCLC.

reviews

The curative effect of sqnsCLC was impressive. As of August 2, 2024, the IBI363 single drug showed breakthrough efficacy. As of August 2, 2024, 134 patients were treated with IBI363. 95. 5% of patients had previously received at least first-line PD- (L) 1 treatment. The median treatment time was 10 weeks. Currently, 77.6% of patients are still being treated. Among 125 patients who underwent at least one tumor evaluation, the overall ORR was 20.8% and DCR was 74.4%.

IBI363 has shown breakthrough efficacy in IO-treated patients with advanced lung squamous cell carcinoma. In the 3 mg/kg dose group, the overall ORR was 34.5% and the DCR was 89.7%; in the 3 mg/kg dose group, 18 patients had an ORR of 50% and a DCR of 88.9% in patients who had been followed up for at least 12 weeks or had completed the study. Under 1mg/kg or 1.5mg/kg treatment, 27 patients had an ORR of 22.2%, DCR of 70.4%, mPFS of 5.5 months, and a 12-month PFS rate of 30.7%.

IBI363 has shown outstanding efficacy in people with low PD-L1 expression. In advanced lung squamous cell carcinoma, ORR was 36.4% and 31.8%, respectively, in subjects with PD-L1 TPS < 1% (n=22) and TPS ≥ 1% (n=22) in the 1/1.5/3 mg/kg dose group. We believe that the study results showed the outstanding efficacy of IBI363 in people with low PD-L1 expression, and that the product benefited a wide range of people.

IBI363 has good safety. Among all 134 subjects, the most common treatment-related adverse events (TRAE) were joint pain, anemia, thyroid dysfunction, and rash. The incidence of grade 3 and above TRAE was 20.1%, and 6.0% of patients stopped taking TRA E. We believe that, with the exception of joint pain, IBI363 shows similar safety signals to previous PD-1 and PD-L1 drugs, and the overall drug safety data is excellent.

IBI363 showed initial excellent data for later-line colorectal cancer. Following the combined plan, 37 patients with advanced colorectal cancer could be enrolled in the Phase I clinical trial. The average number of treatment lines was greater than 3, and patients with liver metastases accounted for 54.3%. The patients all received a combination of IBI363 and 5/7.5 mg/kg of bevacizumab. Among the 32 evaluable patients, the overall ORR was 18.8% and the D CR was 65.6%; in 17 patients with liver metastases, the ORR and DCR were 11.8% and 58.8%; and in the 8 patients treated with IO, the ORR was 25% and the DCR was 62.5%. Currently, the ORR of TAS-102+ bevacizumab as the standard treatment for third-line colorectal cancer is 6%. At the same time, the overall safety of IBI363 was excellent. The incidence rate of TEAES greater than grade 3 was 17.1%, and only one patient stopped treatment due to side effects.

The company's core pipeline continues to advance, and it is expected to usher in a number of catalytic non-tumor pipelines before the first half of next year: ① Weight loss indications for the 6mg standard of mast peptides are expected to be approved. ② Indications for IBI-112 moderate to severe psoriasis are expected to be submitted for marketing, and phase II ulcerative enteritis data will be read out at the same time. ③ IBI302 (VEGF/C) reads out complete phase II 8mg data. In the cancer product pipeline: ① IBI363 (PD-1/IL2α) will display lung cancer and colorectal cancer data on WCLC and ESM O, while reducing the disclosure of more melanoma data. ② IB I 34 3 (CLDN18.2 ADC)

We believe that based on Cinda Biotech's strong R&D capabilities and the efficient advancement of clinical progress in oncology and non-oncology pipelines, the company's catalytic incidents will continue to occur for some time to come, and the company's value is expected to be further enhanced.

Profit forecasts and investment advice

The company's extensive layout on the oncology circuit has begun to take shape, and high-value clinical products are expected to further increase the revenue of the company's oncology circuit and continue to reduce marginal costs. In the non-oncology circuit, the company has carried out an extensive layout in the fields of metabolism, self-immunity, and ophthalmology, and the products already on the market and under development are highly competitive and leading in progress. We expect Cinda Biotech's 2024-2026 revenue of $7.8 billion, $11.38 billion, and $14.87 billion. Using DCF valuation, the company's reasonable market value is HK$112 billion, maintaining the target price at HK$69.01. Maintain a “buy” rating.

Risk analysis

The risk of uncertainty in the development of new drugs. As a technological innovation, new drug research and development has the characteristics of a long R&D cycle, high investment, high risk, and low success rate. From laboratory research to approval of a new drug for marketing, it has to go through many complex steps such as pre-clinical research, clinical trials, new drug registration and marketing, and after-sales supervision. Every step may face the risk of failure. There is also a risk that existing products or treatments will be replaced by new treatments and technologies.

Commercialization risks. Health insurance fees have exceeded expectations, causing the pricing of innovative drugs to fall short of expectations; although the company has exclusive varieties in the release stage, competition in the PD1 and biosimilar markets is fierce, which may lead to a risk that the sales share falls short of expectations or that the sales expense ratio is higher than expected.