Incident: Kangfang Biotech announced 2024 interim results. Revenue for the first half of 2024 was 1.02 billion yuan, and product revenue reached 7.6 billion yuan (+23.9%) yuan. The results were in line with expectations.
Cardonil earned 0.71 billion yuan in the first half of 2024, and two major indications are imminent. Cardonelli's revenue for the first half of 2024 was 0.71 billion yuan. The clinical indications of cardonil for first-line cervical cancer and first-line gastric cancer are progressing smoothly.
In January 2024, the New Indication Marketing Application (SnDA) for first-line treatment of G/GEJ adenocarcinoma with cardonil in combination with chemotherapy was accepted by the NMPA. In April 2024, SNdA was accepted by NMPA for first-line treatment of persistent, recurrent, or metastatic cervical cancer with or without cardonil and chemotherapy with or without bevacizumab.
Evosi earned 0.1 billion yuan and obtained a decisive positive result compared to K drugs. Evosi was approved for listing in May 2024. Within one week of approval, the first batch of goods was achieved, with revenue of 0.1 billion yuan in the first half of the year. The phase III clinical trial (AK112-303/harmoni-2) of first-line treatment of NSCLC (AK112-303/harmoni-2) with Pabolizumab as a single agent with positive PD-L1 expression obtained a decisive positive result, reaching the main PFS study endpoint, which is statistically significant and has significant clinical benefits. This is the first and only phase III clinical trial in the world where a single agent compared with Pabolizil monotherapy yielded positive results.
Continue to promote clinical development plans for innovative products in the field of oncology and self-immunity. The phase III clinical trial of proxil (VEGFR-2) combined with cardonil and chemotherapy for advanced G/GEJJ where first-line treatment failed has achieved the first enrolment. AK117 combined with azacitidine was enrolled in a global multicenter phase II clinical trial for first-line treatment of myelodysplastic syndrome (MDS). A phase I clinical trial of AK117 combined with AK129 (PD-1/LAG-3) to treat classic Hodgkin lymphoma was approved by the CDE. In the field of metabolism and immunity, the NDAs for the treatment of essential hypercholesterolemia and mixed hyperlipidemia, and the heterozygous familial hypercholesterolemia drug inucizumab and the drug iroximab to treat psoriasis are under review.
Profit forecast: With the gradual focus of the company's R&D and the gradual implementation of the pipeline, there is sufficient momentum for long-term growth in the company's performance. The company's revenue for 2024-2026 is estimated at 25.8 billion yuan, 42.4 billion yuan, and 6.04 billion yuan, respectively.
Risk warning: R&D progress falls short of expectations, commercialization of core products falls short of expectations, policy risks.