Prescriptions for Alteogen's Keytruda SC (Keytruda Qlex) are on the rise. U.S.-based Merck (MSD), the developer of Keytruda, the world's top blockbuster immunotherapy drug (a pharmaceutical with annual sales exceeding 1 trillion won), has a strategy to rapidly increase the global market share of Keytruda Qlex. The structure is such that as Keytruda Qlex revenue grows, it positively impacts the performance of co-developer Alteogen.
According to industry sources on Monday, Keytruda Qlex's revenue in the third quarter of this year was $830 million (approximately 1.11 trillion won), a 79.3% increase from the previous quarter. As of the third quarter of this year, the subcutaneous injection (SC) formulation conversion rate for Keytruda is 9.7%. MSD expects to raise the SC formulation conversion rate for Keytruda to 30-40% by 2027. Keytruda Qlex is a product that converts the intravenous (IV) formulation of Keytruda into a subcutaneous injection using Alteogen's proprietary technology, 'ALT-B4'.
Keytruda, the immunotherapy drug with the largest revenue scale worldwide, recorded revenue of $8.6 billion (approximately 11.46 trillion won) in the third quarter of this year. It continued its growth trend, increasing by approximately 5.6% from the same period last year. Keytruda's global revenue growth was supported by expanded use in early-stage cancer types and relatively robust demand in metastatic cancer indications. In particular, usage expanded in early-stage cancer types such as triple-negative breast cancer, cervical cancer, head and neck cancer, and bladder cancer. Demand also increased in metastatic urothelial carcinoma, among others.
MSD emphasized that it is firmly establishing its intellectual property position worldwide despite the European patent dispute over Keytruda Qlex. Previously, a Dutch court ordered an interim measure to halt the manufacture and sale of Keytruda Qlex based on European patents. The countries subject to the suspension are Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland, and the Netherlands.
MSD expected that the impact on total sales volume would be limited because the proportion of the regions where the temporary sales suspension decision for Keytruda Qlex was made is relatively small. It also plans to continue efforts to overturn the court's decision.
MSD plans to actively supply Keytruda Qlex to the United Kingdom, Canada, and Austria, which are considered regions with relatively high interest in Keytruda's subcutaneous injection formulation. The UK already shows a relatively high level of subcutaneous injection adoption. Canada is in the stage of preparing for launch. Along with this, following approval in Japan and China, launch preparations are underway.
MSD is also hastening combination clinical trials with various treatments to ensure Keytruda's sustained growth. 'Intismeran,' a personalized cancer treatment vaccine being co-developed with U.S.-based Moderna, is representative, and the scope of clinical trials is expanding. Currently, four Phase 3 clinical trials and five Phase 2 clinical trials for the combination administration of Keytruda and Intismeran are underway simultaneously. The indication development scope, which began with early-stage melanoma, has expanded to lung cancer, bladder cancer, renal cell carcinoma, and others.
Alteogen can receive milestones (technology fees) and royalties based on the sales performance of Keytruda Qlex. This is against the backdrop of expectations for revenue growth from the expansion of Keytruda's indications and the development of combination therapies with cancer vaccines, among others.
An Alteogen official explained, "MSD is increasing the conversion rate of Keytruda Qlex and expanding regions to target in overseas markets, while also continuing investment in new pipelines and combination therapy development in preparation for after the expiration of Keytruda's patents." The official added, "The commercial growth of Keytruda Qlex and the development of next-generation anticancer drugs will play an important role in MSD's medium- to long-term growth strategy."
The official further added, "Keytruda's intravenous and subcutaneous injection formulations are being approved together for new indications, and especially since cancer vaccines are administered via intramuscular injection, combination therapy with the subcutaneous formulation is more suitable." The official concluded, "The expansion of Keytruda Qlex administration supports MSD's confidence in Keytruda's growth potential."
in THEBIO
