According to the Red Star Capital Bureau on October 13, Kelun Biotech (06990.HK) announced yesterday evening that its drug Lukang Satuzumab (Jiatailai®) has been approved by the National Medical Products Administration for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with positive epidermal growth factor receptor (EGFR) gene mutations that have progressed after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs).

Kelun Botai's parent company Kelun Pharmaceutical(002422.SZ) told the Red Star Capital Bureau that the approval of this indication means that patients can directly use Lucansatumomab without chemotherapy after subsequent progress of EGFR-TKI treatment, which is conducive to expanding the scope of application for patients.

It is reported that Lukangsatuzumab is a core product of Kelun Biotech. In the first half of this year, over 90% of Kelun Biotech's pharmaceutical sales revenue came from Lukangsatuzumab, and BD (business development) revenue related to this drug is also a significant source of revenue for Kelun Biotech. These changes will also affect the performance of its parent company, Kelun Pharmaceutical .

Two lung cancer-related indications have been approved

Public information shows that this is the third indication approved for ruconazole since it was launched in November 2024. Previously, the two indications approved for the drug were: unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) that has received at least two systemic treatments (at least one of which was for the advanced or metastatic stage), and locally advanced or metastatic non-squamous NSCLC that is EGFR mutation-positive and has progressed after EGFR-TKI and platinum-containing chemotherapy.

Kelun Pharmaceutical explained to the Red Star Capital Bureau that the second indication is different from the recently approved indication. The previously approved treatment for non-squamous NSCLC requires EGFR-TKI treatment and chemotherapy, while the newly approved indication means that patients can directly use ruconazole without chemotherapy after subsequent progress in EGFR-TKI treatment, which is conducive to expanding the scope of application for patients.

It is understood that Lukang Satuzumab is a drug with independent intellectual property rights owned by Kelun Biotech.The new TROP2 ADC is primarily indicated for advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), and gynecological tumors. It is the world's first TROP2 ADC approved for lung cancer and the first and only ADC to demonstrate a significant overall survival (OS) benefit compared to platinum-based doublet chemotherapy. It is also approved for advanced NSCLC that has progressed after prior TKI therapy (2L).

Data shows that NSCLC is a common type of lung cancer, accounting for over 80% of lung cancer patients. EGFR-TKI therapy is a commonly used targeted therapy for advanced NSCLC. However, the downside of this treatment is the high risk of developing drug resistance after long-term use. ADC drugs are promising solutions to this problem.

It is the core source of income for Kelun Botai

Red Star Capital noted that Lukang Satuzumab is Kelunbotai's core revenue source. In the first half of 2025, the first half of the drug's approval, sales of the product reached 302 million yuan, accounting for 97.6% of the company's total drug sales and 31.8% of its total revenue.

The contribution of Lukang Satuzumab to Kelun Biotech’s revenue is also reflected in licensing and cooperation income. In May 2022, Kelun Biotech granted MerckExclusive rights to develop, use, manufacture and commercialize ruconazole in all regions outside of Greater China.

Under the agreement, Merck will pay Kelun Biotech an upfront payment, various milestone payments, and royalties based on net sales, depending on the stage of commercial development. Kelun Biotech received a one-time, non-refundable payment of US$30 million upon signing the agreement amendment, with cumulative milestone payments capped at US$1.363 billion.

Public information shows that Kelun Botai is a wholly-owned subsidiary of A-share listed Kelun Pharmaceutical. Kelun Pharmaceutical directly holds a 51.45% stake in Kelun Botai and indirectly holds a 12.87% stake through Chengdu Kelun Jingchuan Technology Co., Ltd.

Although Kelun Biotech has achieved a breakthrough in the launch of Lukang Satuzumab since 2024, it is still in a loss-making state due to high R&D expenses, with a loss of 150 million yuan in the first half of this year. Kelun Biotech said that this is mainly due to the innovative drugProduct sales revenue was impacted by the year-on-year decrease in licensing revenue (milestones).

In contrast, Kelun Pharmaceutical has maintained significant performance growth in recent years, with both revenue and net profit attributable to parent company reaching record highs since its listing in 2024. However, in the first half of this year, Kelun Pharmaceutical's revenue was 9.08 billion yuan, a year-on-year decrease of 23.2%, and its net profit attributable to parent company was 1 billion yuan, a year-on-year decrease of 44.4%. Kelun Pharmaceutical explained that this was mainly due to a decrease in innovative drug licensing revenue, declining sales and prices in its biofermentation segment, a decline in market demand for infusion and non-infusion preparations, and a decline in net profits from associated companies.

At present, Kelun Biotech's revenue is mainly reflected in Kelun Pharmaceutical's financial report through the revenue from pharmaceutical research and development projects. In the first half of this year, Kelun Pharmaceutical's revenue from pharmaceutical research and development projects was 640 million yuan, accounting for 7% of Kelun Pharmaceutical's total revenue.

Regarding the business relationship between the two companies, Kelun Pharmaceutical told the Red Star Capital Bureau that the two companies operate independently, but Kelun Pharmaceutical will provide sales support to Kelun Biotech. For example, the cetuximab previously launched by Kelun Biotech was sold by Kelun Pharmaceutical.

Cetuximab is not an original research drug of Kelun Biotech, and sales of its core product, Lukangsatuzumab, are still handled by Kelun Biotech itself. Kelun Pharmaceutical stated that this is because the sales team of innovative drugs requires experience with relevant indications.

https://finance.eastmoney.com/a/202510133532577979.html