Leclaza launches in Germany, accelerates Europe entry

Billing code registration completed… expects prescription growth in Europe's largest pharmaceutical market

Photo of Yuhan Corp’s Leclaza (source: Yuhan Corp)

Leclaza, a lung cancer drug developed by Yuhan Corporation, has successfully entered the health insurance reimbursement system in Germany, the largest pharmaceutical market in Europe. This listing is expected to accelerate Leclaza’s entry into other European countries.

According to the biotech industry on the 12th, Germany’s Federal Joint Committee (G-BA), responsible for evaluating health insurance reimbursement in Germany, assigned billing codes 761990MO and 761990MP to Leclaza 80 mg and 240 mg, respectively, starting this month. Billing codes are assigned after drug price negotiations are finalized, enabling hospitals to bill health insurance for the medication after prescribing it.

Leclaza is a third-generation treatment for non-small cell lung cancer (NSCLC) targeting epidermal growth factor receptor (EGFR) mutations. It received approval in Korea in January 2021 as the country's 31st domestically developed new drug. The combination therapy of Leclaza and Rybrevant received approval from the U.S. Food and Drug Administration (FDA) in August 2024 as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed EGFR exon 19 deletion or exon 21 L858R substitution mutation.

Later, at the end of 2024, the European Commission (EC) also approved the Lecelaza and Johnson and Johnson’s Rybrevant combination therapy as a first-line treatment for EGFR-mutated NSCLC. Subsequently, in July of last year, the G-BA determined that the combination therapy had sufficient clinical value to qualify for health insurance reimbursement.

Under Germany’s Social Code Book V (SGB V), new drugs can enter the market immediately after receiving marketing authorization. Within approximately 6 months, the G-BA evaluates the drug’s clinical benefit, after which price negotiations with health insurers begin. Negotiations typically conclude within another 6 months, after which hospital billing codes are assigned.

The G-BA ultimately determined that the combination therapy of Leclaza and Rybrevant positively impacts survival rates for lung cancer patients. It particularly noted a relatively pronounced survival benefit in the patient group aged 65 and under. The G-BA estimated the annual number of patients expected to receive treatment in Germany to be between 1,250 and 3,025.

Germany is widely regarded as one of the most stringent countries in Europe in terms of drug pricing decisions. However, Lazertinib entered the reimbursement system relatively smoothly, being recognized for its clinical value. Once prescriptions gain traction in the German market, it is expected to positively influence drug pricing negotiations and insurance listings in other European countries as well.

Once sales expand in major European countries, Yuhan Corporation is expected to receive additional licensing fees. Yuhan has not yet received the USD 30 million milestone payment for Leclaza’s approval in Europe. In addition, if sales grow in the European market, the company will receive royalties based on a certain percentage of sales according to the licensing agreement.

Yuhan Corporation's total licensing revenue over the 7 years from 2019 to last year amounted to KRW 460 billion. Of this amount, cumulative licensing revenue from Lazertinib technology transfer alone has reached approximately USD 275 million, including upfront payments and development and regulatory milestones.

Yuhan Corporation received a non-refundable upfront payment of USD 50 million when it licensed Leclaza to Janssen Biotech, a Johnson & Johnson subsidiary, in November 2018. Subsequently, a USD 35 million milestone was paid in 2020 when the clinical trial for the combination therapy of Rybrevant and Leclaza began. The company received an additional USD 65 million the same year when patient enrollment for the clinical trial began.

The company continued to generate milestone revenues thereafter based on progress in development and regulatory approvals. A USD 60 million milestone was triggered by the 2024 U.S. Food and Drug Administration (FDA) approval. Last year, the company received additional milestone payments of USD 15 million for Japanese approval and USD 45 million for Chinese approval.