[NA Eun-kyung, Edaily Reporter] On Aug. 12, the domestic pharmaceutical, biotech, and healthcare market rallied in response to news that the U.S. Congress is reviving the Biodefense Law, sending related shares higher. Later in the session, reports of a government push to legalize abortion pills lifted Hyundai Pharm, which holds the domestic rights to the drug.

Genomictree also gained after PharmEdaily published an article on the commercialization of its bladder cancer diagnostic test, EarlyTect-B. The stock jumped 13.18 percent.

Biodefense Law Spurs Gains in Beneficiaries

According to KG Zeroin MP Doctor, cell culture media developer Accel Therapeutics rose 11.14 percent to close at 3,790 won. IBK Investment & Securities named the company as a prime beneficiary if the Biodefense Law passes in the United States.

U.S. President Donald Trump (right) and Chinese President Xi Jinping (left) talk during a meeting in Beijing in 2017. (Source: AP Photo)

The Biodefense Law would ban all contracts with bio companies designated by U.S. federal agencies, mainly targeting Chinese firms. Analyst Lee Geon-jae at IBK said that if enacted, the law would reshape the entire value chain, from federally funded projects to big pharma clinical trials. Even if delayed or scrapped, voluntary risk mitigation would weaken cooperation with Chinese firms and create growth opportunities for domestic companies.

Accel Therapeutics said it plans to seize this opportunity to enter the U.S. market. “We aim to create opportunities in the U.S., starting with large clients,” a company official said, adding that it is considering white labeling its products under established global materials and equipment brands to ease market entry.

White labeling allows companies with development capabilities but limited marketing and distribution to sell products under the brand of a dominant market player. Korean bio equipment firm MicroDigital has a similar arrangement with U.S.-based Parker Hannifin to supply single-use bioreactor systems locally.

Other stocks cited in the IBK report, including Binex and Curiox Biosystems, also rebounded modestly.

Hyundai Pharm Climbs on Abortion Pill Reform Momentum

Hyundai Pharm shares spiked after reports at around 3 p.m. that the government is pushing to legalize abortion pills. The stock climbed as much as 9.3 percent to 4,230 won from the previous close of 3,870 won.

Hyundai Pharm holds the exclusive domestic rights to Mifegymiso, an oral abortion pill developed by UK-based Linepharma International. The company signed the deal in 2020 after the Constitutional Court struck down the abortion ban in 2019 and applied for product approval in July 2021.

Regulatory delays have persisted for four years due to repeated data supplement requests from the Ministry of Food and Drug Safety and the absence of replacement legislation. Although the ministry has said the approval process is separate from the legal vacuum, lawmakers and observers have viewed it as politically sensitive.

The outlook shifted after a ruling party lawmaker introduced a bill last month to allow surgical and medical abortions and extend insurance coverage. Reports said the Presidential Committee on National Agenda will include abortion pill legalization in the five-year policy plan to be announced Aug. 13.

Industry estimates suggest that illegally distributed Mifegymiso tablets total about 1 million annually. Even with a lower-than-expected price and continued black market sales, annual revenue could reach several hundred billion won.

Genomictree Rises on EarlyTect-B Commercialization Outlook

On Aug. 11, Genomictree’s shares rose from 15,840 won to 17,820 won after PharmEdaily’s pay-to-read article on EarlyTect-B’s commercialization was made public.

Current bladder cancer screening relies on cystoscopy, which requires urethral insertion and causes patient discomfort. EarlyTect-B, in contrast, uses a urine sample and has shown 89.2 percent sensitivity and 87.8 percent specificity.

The company submitted additional clinical data and central pathology reviews to the MFDS late last month and is awaiting a final decision. Fast-track review for in vitro diagnostics typically begins within about 30 days and may conclude within one to two months if requirements are met, putting reimbursement as early as the first quarter of next year.

Genomictree expects no further data requests, citing alignment between urologist and pathologist assessments. The company said EarlyTect-B is likely to be priced above 100,000 won. Based on 3.35 million potential patients and a 100,000 won price, maximum annual revenue could reach 335 billion won.