Approved as the first SC-type PD-1 inhibitor in China… Secured indications for 19 solid cancers
Started supply to Korea, followed by approval from Japan, then to China… Pay attention to the actual SC switching speed
Keytruda SC, based on Alteogen's (196170) subcutaneous injection (SC) formulation modification technology, has entered the Chinese market. Product supply began in Korea on the 1st, and approval was obtained in Japan last month, and the scope of commercialization in the Asian market has expanded with the addition of China, which has a large cancer patient base.
Global pharmaceutical company Merck (MSD) announced on the 29th of last month that its PD-1 inhibitor pembrolizumab subcutaneous injection formulation has been approved by China's National Medical Products Administration (NMPA).
The scope of approval is 19 solid cancer indications. Keytruda SC is the first and currently only PD-1 inhibitor approved for subcutaneous injection in China.
Keytruda SC is equipped with human hyaluronidase variant ALT-B4 (ingredient name: Verahyaluronidase alpha) developed by Alteogen. This is a technology that allows Keytruda to be administered subcutaneously instead of the existing intravenous (IV) method.
Starting from the United States to Korea, China, and Japan... Global Permission Expansion
Keytruda SC's global approval began in the United States in September last year. In November of the same year, it continued to the European Union (EU), and this year the scope expanded to include Canada.
Recently, approval and launch in major Asian markets are continuing. In Korea, actual supply began on October 1 after receiving approval from the Ministry of Food and Drug Safety in May. It also received approval for manufacturing and sales in Japan last month. The local product name is ‘KEYJECT’, and it can be used for all indications for which Keytruda has been approved in Japan.
With the addition of China, Keytruda SC has laid the foundation for commercialization in major Asian markets such as Korea, China, and Japan, following North America and Europe.
It is also noticeable that the number of permitted areas has continued to increase in a short period of time. About a year after its first approval in the U.S., it entered major markets in Asia via North America and Europe. As approvals from individual countries are sequentially accumulated, the number of areas where actual sales are possible is also increasing.
19 indications at once… Large market in China opens
Approval in China is also significant in terms of market size. According to the International Agency for Research on Cancer (IARC) under the World Health Organization (WHO), the number of new cancer cases in China in 2022 was approximately 4.82 million. Considering that there were approximately 20 million new cancer cases worldwide during the same period, China's share is significant.
In this approval, 19 solid cancer indications were secured at once. As MSD has been supplying the existing IV Keytruda for various cancer types in China, the SC formulation can also enter the market based on the existing treatment area of Keytruda.
In particular, a number of PD-1-based immunotherapy drugs are already competing in China. Among these, Keytruda SC is the first and currently only PD-1 inhibitor approved for subcutaneous injection. There is interest in what difference the fact that the administration time can be significantly reduced compared to existing IV formulations will make in the Chinese market.
Considering the scale of cancer patients in China, the future demand for SC conversion is also something to pay attention to. Unlike products that pioneer new therapeutic areas from scratch, Keytruda SC can utilize the indications and treatment base secured by existing IV formulations. After actual sales begin in China, the extent to which existing IV demand moves to SC is expected to be an indicator of the speed of market settlement.
Beyond permission and selling… Focus on SC transition speed
From Alteogen's perspective, the Chinese approval has further expanded the market in which Keytruda SC can be sold.
Alteogen's agreement with MSD includes sales milestones totaling $1 billion tied to Keytruda SC sales. Alteogen has already received its first sales milestone of $25 million.
Product supply began in Korea from this day, and approval has also been completed in Japan and China. Keytruda SC sales, which are being carried out first in the United States, are also laying the groundwork to expand to other major markets.
Going forward, the timing of launch in each market and how much existing IV Keytruda demand shifts to the SC formulation will be important. In particular, the speed at which the SC conversion progresses after actual sales begin in China, where 19 indications have been secured, is also linked to Alteogen's follow-up sales milestones.
