[Edaily Reporter KIM JI-WAN ] On the 14th, the domestic pharmaceutical and life sciences sectors showed a broad decline.

The pharmaceutical sector index fell 2.33% from the previous trading day, with 41 of the 160 listed stocks rising. Thirteen stocks remained unchanged, while 106 declined.

The life sciences sector fell 5.97%, marking the steepest decline among all sectors. Of the 91 stocks in the sector, 24 rose, 10 remained unchanged, and 57 fell, reflecting a sluggish performance alongside the pharmaceutical sector.

In the market, related stocks rose after President Lee Jae-myung announced plans to reform the system to allow the administration of the abortion drug “Mifjin.”

Hyundai pharm: Will President Lee’s Remarks Break Through the Stalled Review?

Hyundai pharm(004310)hit its daily price limit after President Lee Jae-myung made remarks suggesting that the system should be improved to allow for the administration of the abortion drug “Mifjin.”

According to KG Zeroin’s MP DOCTOR on that day, Hyundai pharm rose 29.84% (1,395 won) from the previous trading day to 6,070 won, reaching the daily price limit.

During a Cabinet meeting that day, President Lee made remarks regarding Mifjin, stating, “Even if the government faces difficulties, we must ensure that it can be administered appropriately.” This is interpreted to mean that the government should regulate, within the formal system, the circulation of abortion drugs—which are not officially approved in South Korea—that are currently distributed through unofficial channels such as direct overseas purchases.

Mifjin is a combination drug containing two active ingredients: “mifepristone” and “misoprostol.”

The product for which Hyundai pharm signed a domestic distribution rights and exclusive supply agreement with the British pharmaceutical company Linepharma International in 2021 is “Mifji-Miso,” a combination pack containing both mifepristone and misoprostol. Mifji-Miso consists of one 200 mg tablet of mifepristone and four 200 μg tablets of misoprostol.

Mifepristone inhibits the action of progesterone, which is necessary for maintaining pregnancy, while misoprostol induces uterine contractions to facilitate the expulsion of pregnancy tissue. The World Health Organization (WHO) has included mifepristone and misoprostol on its List of Essential Medicines and recommends medical abortion using these two ingredients as a safe and effective method.

Hyundai pharm resubmitted its application for marketing authorization of Mifji-Miso to the Ministry of Food and Drug Safety at the end of 2024. However, the review and introduction of the product have been delayed due to a legislative gap regarding the scope of permitted abortions and usage criteria.

Three clinical trials conducted in the United States and Mexico were submitted as the basis for the marketing authorization application. The reported success rates for pregnancy termination in these trials were 94.9%, 96.2%, and 97.3%, respectively. The company maintains that the method of first taking 200 mg of mifepristone followed by 800 μg of misoprostol is effective for terminating early pregnancies of 63 days or less.

However, the domestic approval process has long been stalled due to a legal vacuum.

The Ministry of Food and Drug Safety (MFDS) has consistently maintained that key approval conditions—such as efficacy, dosage and administration, and risk management plans—can only be established once the legality of medication-based abortion and the permissible gestational age are defined by law. Consequently, while Mifegymiso is technically undergoing the review process, it is understood that substantive review has been limited.

In 2019, the Constitutional Court ruled that the criminalization of abortion under the Criminal Code was unconstitutional, and the relevant provisions of the Criminal Code ceased to be in effect as of 2021. However, follow-up legislation regulating the timing and methods of permitted abortions, criteria for the use of medications, and the responsibilities of healthcare professionals has not yet been finalized.

Meanwhile, the unofficial online distribution market has expanded. A survey found that over the past five years alone, there have been more than 2,600 cases of individuals caught illegally selling or brokering abortion medications online. Safety concerns have been consistently raised as these medications—whose authenticity and dosage are difficult to verify—are distributed without a medical diagnosis or guidance on proper use.

A pharmaceutical industry official stated, “The momentum for policy implementation has become clearer than before, as the President personally mentioned the need to introduce Mifegyn,” but added, “We will have to wait and see the results of the Ministry of Food and Drug Safety’s review and the subsequent institutional design process to determine the actual product launch date and market size.”

DAE HWA PHARM CO., LTD and Hyundai pharm Rise in Tandem on 2.6% Stake

DAE HWA PHARM CO., LTD(067080)Daehwa Pharmaceutical saw double-digit gains, buoyed by President Lee Jae-myung’s remarks regarding the abortion drug “Mifjin.” The rise is believed to be driven by buying interest as the company’s stake in Hyundai pharm—which is considered a beneficiary of Mifjin’s introduction—came into focus.

According to MP Doctor that day, DAE HWA PHARM CO., LTD closed at 10,150 won, up 1,080 won (11.91%) from the previous trading day.

As Hyundai pharm’s stock price surged, investor interest also spread to DAE HWA PHARM CO., LTD, which has established a strategic partnership with Hyundai pharm.

DAE HWA PHARM CO., LTD acquired 844,493 shares of Hyundai pharm for approximately 10.8 billion won last February. Its stake stands at 2.6% following the acquisition. At the time, DAE HWA PHARM CO., LTD stated that the purpose of the acquisition was to strengthen business cooperation, establish a strategic partnership, and create mid- to long-term business synergies.

An industry insider analyzed, “Although DAE HWA PHARM CO., LTD is not directly participating in the Mifjin-related business, it appears to have focused on its status as a major shareholder and strategic partner of Hyundai pharm,” adding, “Expectations that future cooperation between the two companies could expand to include joint research and development (R&D), production, distribution, and sales likely influenced the stock price.”

However, to date, DAE HWA PHARM CO., LTD has not officially announced that it will directly participate in the domestic approval, supply, or distribution of Mifegymiso.

Bio Solution Co.,Ltd. Receives IND Approval for New Injectable Osteoarthritis Drug

Bio Solution Co.,Ltd.(086820)closed higher on news that it had received

approval

for its domestic Investigational

New Drug

(IND) application for “SperoCure,” an injectable treatment for knee osteoarthritis.

According to MP Doctor, Bio Solution Co.,Ltd. closed at 5,930 won, up 320 won (5.70%) from the previous trading day. The start of clinical trials for this cell therapy—which involves a single intra-articular injection without the need for knee surgery—is believed to have boosted investor sentiment.

Bio Solution Co.,Ltd. received approval from the Ministry of Food and Drug Safety for Phase 1 and 2a clinical trials of SperoCure in South Korea. This comes approximately eight months after the company submitted its IND application last November.

SperoCure is an allogeneic cell therapy that combines 3D cell spheroid culture technology with cartilage differentiation stimulation technology. It aims to develop a disease-modifying osteoarthritis drug (DMOAD) that continuously secretes therapeutic active ingredients within the joint to reduce pain while simultaneously improving damaged cartilage structure.

This clinical trial will be conducted on patients with Kellgren-Lawrence (K&L) Grade 2 and 3 knee osteoarthritis. In Phase 1, safety and tolerability will be evaluated across different dose levels in up to 18 participants to determine the appropriate dose.

In the subsequent Phase 2a trial, 41 or up to 68 participants will be recruited to verify efficacy in a multicenter, randomized, double-blind, placebo-controlled study. Twenty-four weeks after administration, the Visual Analog Scale (VAS) for pain and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for joint function will be measured, and the potential for improvement in cartilage structure will be explored using magnetic resonance imaging (MRI) and biomarkers.

SperoCure was developed with support from the Inter-Ministerial Regenerative Medicine Technology Development Project, jointly promoted by the Ministry of Science and ICT and the Ministry of Health and Welfare. Bio Solution Co.,Ltd. has already filed for domestic patents and submitted a Patent Cooperation Treaty (PCT) application.

Lee Jeong-seon, CEO of Bio Solution Co.,Ltd., stated, “SperoCure is a next-generation core new drug created by combining Cartilife’s commercialization experience with Cartiroid’s clinical development expertise,” adding, “Based on the results of our domestic clinical trials, we will accelerate our expansion into overseas clinical trials and the establishment of global business development partnerships.”