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First Shanghai: The target price for the “buy” rating for Kangfang Bio-B (09926) is HK$144.9

智通財經·12/15/2025 08:25:02
語音播報

The Zhitong Finance App learned that the first Shanghai released a research report stating that Kangfang Bio-B (09926) has made many advances in the core product pipeline. Cardonil has been approved as an indication for cervical cancer and gastric cancer and included in medical insurance, and several new indications have entered phase III clinical trials; evosil has positive data in the field of non-small cell lung cancer, and overseas marketing applications are in progress; pimiprizumab has been successfully approved for marketing by the FDA. In addition, many products are covered by medical insurance or are in the advanced clinical stages. Using the DCF valuation method, a target price of HK$144.9 was obtained, with room for an increase of 23.4% from the current price, and the purchase rating.

First, the main views of Shanghai are as follows:

Financial performance

In the first half of 2025, Kangfang Biotech's revenue increased by 49.2% year-on-year to 1.4 billion yuan. In addition to license fee revenue, the company recorded total revenue of 1.41 billion yuan, gross margin of 79.4%, and R&D expenses increased 23.0% to 730 million yuan. At the end of August 2025, the company placed 2,355 billion shares at a price of HK$14.954 per share and received a net financing amount of HK$3.493 billion. The company's net cash in hand after the distribution is estimated to be $5.8 billion.

Product pipeline progress

(1) Cardonil AK104 (PD-1/CTLA-4): Approved for first-line cervical cancer and first-line gastric cancer, and is covered by medical insurance; gastric cancer after PD- (L) 1 progression, adjuvant treatment after surgery for hepatocellular carcinoma, intermediate to advanced unresectable hepatocellular carcinoma, first-line PD-L1 negative non-small cell lung cancer, and non-small cell lung cancer after synchronized/sequential chemotherapy are in phase III clinical stage. Among them, IO-resistant squamous non-small cell lung cancer was included as a breakthrough therapy in April 2025, IO-resistant hepatocellular carcinoma began a global phase II clinical trial, and first-line gastric cancer a global phase III clinical trial.

(2) Evosi AK112 (PD-1/VEGF): Used for non-small cell lung cancer progressing after EGFR treatment, was approved in May 2024 and included in the 2025 medical insurance; the overall survival (OS) data from the Summit Global Harmoni study was updated to HR=0.78, p=0.0332, with prominent North American subgroup data (HR=0.70). Summit is expected to submit a biologics license application to the US FDA in the fourth quarter of 2025. First-line PD-L1 positive non-small cell lung cancer was approved in April 2025 and covered by 2026 medical insurance. The mid-OS phase analysis conducted at 39% maturity in April of this year (the alpha allocation value in this analysis was only 0.0001) showed that the OS HR of evosil compared with pabolizumab was 0.777, reducing the risk of death by 22.3%. The marketing application for first-line squamous non-small cell lung cancer in China was accepted by the State Drug Administration in July 2025; non-small cell lung cancer that progressed after immunotherapy, limited-stage small cell lung cancer, first-line biliary tract cancer, first-line colorectal cancer, first-line pancreatic cancer, first-line pancreatic cancer, first-line PD-L1-positive head and neck squamous cancer, and first-line triple-negative breast cancer are undergoing phase III clinical trials. Overseas partner Summit is carrying out first-line non-small cell lung cancer phase III clinical trials (Harmoni-3). Squamous cell carcinoma is expected to complete the enrollment of 600 patients in the first half of 2026, and the pre-set number of events required for progression-free survival analysis in the second half of the year. Mid-term OS analysis may be carried out during the same period; non-squamous cell cancer is expected to complete the enrollment of 1,000 patients in the first half of 2026, and the estimated number of events required for PFS analysis is reached in the first half of 2027. Summit has launched a first-line phase III clinical trial for colorectal cancer and plans to launch a first-line phase III clinical trial for head and neck squamous cell cancer.

(3) Pimiprizumab AK105 (PD-1): In April 2025, the FDA approved it for first-line and second-line nasopharyngeal cancer treatment. This is the company's first innovative biopharmaceutical that has been independently led and successfully approved and marketed by the FDA. It marks that the company's innovative drug research and development strength and drug production quality management guarantee system have obtained authoritative certification from the highest international standards.

(4) Inucimab AK102 (PCSK) and iroximab AK101 (IL-12/IL-23) are included in 2026 health insurance.

(5) Gumocizumab AK111 (IL-17): The marketing application for moderate to severe psoriasis was accepted in January 2025.

(6) Other products include: raffalizumab AK117 (CD47), ploximab AK109 (VEGFR-2), and mandoximab AK120 (IL-4R) are in clinical phase III; AK138D1 (HER3 ADC) and AK146D1 (Trop2/Nectin4 ADC) have carried out global clinical phase I and are preparing a combined dosage plan with immunotherapy 2.0.