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Yuhan Leclaza clinical phase 3 cost exceeds 100 billion
by Chon, Seung-Hyun Nov 20, 2023 05:50am
The development cost invested by Yuhan's new anti-cancer drug Leclaza in the Phase 3 clinical trial has exceeded 100 billion won. Three years after the start of the clinical trial, the cost of development is also increasing. Yuhan was approved as a primary treatment based on the efficacy and safety of Leclaza confirmed in the clinical trial, and the salary expansion was also in the countdown. According to the Financial Supervisory Service on the 16th, as of the end of the third quarter, the total development cost accounting for as intangible assets by Yuhan Corporation was 119 billion won. It increased by 3.9 billion won in three months from 1151 billion won at the end of the first half of the year. In 2019, the Financial Supervisory Service set a standard that accounting assets can only be processed if there is a technical feasibility for R&D tasks such as new drugs. The Financial Supervisory Service proposed the asset-enabled phase of R&D costs, with phase 3 clinical trials for new drugs and phase 1 clinical approval for biosimilars. Generics can be assetized after the biometric test plan is approved. The intangible assets reflected by Yuhan in its development expenses are the largest proportion of Lexha. At the end of the third quarter, Leclaza development cost of intangible assets was 101.1 billion won. It means that more than 100 billion won has been invested in aleclaza clinical phase 3 expenses. Leclaza is a treatment for non-small cell lung cancer that was approved as the 31st new drug developed in Korea in January 2021. Patients with locallyprogressive or metaplastic non-small cell lung cancer who are resistant to T790M after administration of the first and 2nd generation epithelial growth factor (EGFR) tyrosinase suppressant (TKI) are subject to administration. It interferes with the transmission of signals involved in the growth of lung cancer cells and acts as a mechanism to inhibit the proliferation and growth of lung cancer cells. Leclaza recognized 32.6 billion won in development costs as intangible assets for the first time in the fourth quarter of 2020. As the clinical phase 3 trial started in earnest, the development cost was reflected as an intangible asset. Leclaza development cost of intangible assets increased to 61.4 billion won at the end of 2021 and rose to 88 billion won, an additional 26.6 billion won last year. This year, the development cost of Leclaza’s intangible assets increased by a total of 13.3 billion won. 5 billion won and 4.7 billion won in clinical phase 3 expenses were invested in the first and second quarters, respectively. In the third quarter, 3.4 billion won was added, exceeding 100 billion won for the first time. Leclaza is challenging the primary treatment health insurance benefits. In June, Lexar received additional permission as a primary treatment, two years and five months after receiving domestic approval. Reclaza identified statistically significant progression-free survival (PFS) improvements in a multi-country clinical phase 3 trial. A Phase III trial (LASER301) conducted on 393 active EGFR mutant-positive topical advanced or metaplastic lung cancers that had never been treated demonstrated superior safety and effectiveness over conventional therapies. The clinical results were unveiled at the Asian General Conference of the European Society of Oncology in Singapore last year. Yuhan has recently applied to health authorities to apply Leclaza primary treatment. Yuhan plans to provide patients with free drugs for clinical trials for primary therapeutic purposes through the Expanded Access Program (EAP). The price of Leclaza’s monthly medicine is about 6 million won. According to IQVIA, a pharmaceutical research institute, Leclaza’s sales in the first half of last year were 10.3 billion won, up 49.5% from the same period last year. Sales in the first quarter were 5.1 billion won, up 57.4% from the previous year, and in the second quarter, it recorded 5.2 billion won, up 42.5% from the previous year. Cumulative sales since the release of Leclaza have been 30.2 billion won. Cumulative sales exceeded 30 billion won within two years of domestic launch.