[Edaily Reporter Kim Seung-kwon ] On the 23rd, the domestic stock market surged across the board, driven by expectations of expanded investment in artificial intelligence (AI) and a rally in biotech stocks. In particular, the KOSDAQ market witnessed an unusual trading session at 2:27 p.m., when biotech stocks soared in unison—led by a sharp rise in the sector’s bellwether, Alteogen Inc.(196170)—triggering a “buy-side sidecar” (a temporary suspension of program buy orders).

Analysts say news of a patent victory in a European court fueled expectations that the “Halozime risk” had been resolved. SAM CHUN DANG PHARM CO. LTD(000250), which had recently experienced a roller-coaster ride due to FDA-related issues, also joined the rebound, though the market remains cautious regarding the actual impact of the news.

Alteogen Inc. Gains the Upper Hand in European Patent Battle… “IP Risks Largely Resolved”

According to KG Zeroin MP Doctor, Alteogen Inc. closed at 302,500 won today. During the session, when the “sidecar” mechanism was triggered, the stock surged as high as 304,500 won, up 13.62% (Maeil Business Newspaper). Considering that the stock price—which had risen to the 520,000 won range earlier this year—had fallen to about half its peak due to royalty controversies and concerns over patent disputes, today’s sharp rise is interpreted as a signal that the patent risks weighing on the market are beginning to subside.

The catalyst came from Europe. The District Court of The Hague in the Netherlands dismissed a preliminary injunction request filed by competitor Halozyme against its partner, MSD (Merck) (Pharm iDaily). Halozime had requested that “Keytruda Qurex,” the subcutaneous (SC) formulation of Keytruda, be excluded from the drug price lists in Denmark and Sweden pending the final ruling on the main case, but this request was denied. This product incorporates Alteogen Inc.’s “ALT-B4” formulation modification platform, which is based on hyaluronidase (PH20). This contrasts with the Munich court’s 2025 ruling granting Halozime a preliminary injunction blocking the product’s launch in Germany, indicating that the tide of the European legal battle has turned in MSD’s favor.

MSD’s advantage has also solidified in the United States. On May 12, the U.S. Patent Trial and Appeal Board (PTAB) invalidated Halozyme’s key patent (US 11,952,600). The ruling cited that the claims were overly broad, as Halozyme sought to assert rights over all 6,753 variants based solely on data from a single PH20 variant. Subsequently, three related family patents were also invalidated, marking the fourth invalidation ruling against Halozime in the U.S. Furthermore, Halozime’s petition for invalidation targeting Alteogen Inc.’s manufacturing method patent (US 12,221,638) was dismissed before the hearing even began.

However, oral arguments in the main lawsuit—in which Halozime alleges patent infringement by Keytruda SC—are scheduled for July 31 in the U.S. District Court for the District of New Jersey, meaning the final showdown is still to come.

Kim Sun-ah, an analyst at Hana Securities, commented, “The invalidity proceedings filed by Halozyme have concluded with a final invalidity decision, and it appears that the remaining 14 family patents will also be sequentially invalidated.” She added, “In the UK, the dispute was resolved when Halozyme abandoned its patents, and in Germany, a motion to revoke the preliminary injunction is pending.”

SAM CHUN DANG PHARM CO. LTD Rebounds on FDA Optimism… “Question the Substance of the News”

SAM CHUN DANG PHARM CO. LTD closed at 165,400 won, up about 8.2% for the day, marking a rebound after four days. This was driven by a rally in KOSDAQ biotech stocks and bargain-hunting, but given the recent extreme volatility, analysts say it is too early to be optimistic about the sustainability of the rebound.

SAM CHUN DANG PHARM CO. LTD’s stock price, which was in the 200,000-won range earlier this year, soared to an intraday high of 1,233,000 won on March 30, fueled by expectations for an “oral obesity treatment,” propelling the company to the top spot in KOSDAQ market capitalization and the status of a “blue-chip stock.” However, shortly after reaching that peak, the company was designated as a “non-compliant discloser” in April—partly due to its decision to release sales results for its Eylea biosimilar in Canada via a press release rather than a formal regulatory filing—and on the 21st, the stock plummeted to the daily lower price limit (167,800 won), marking a crash of over 86% from its March high. This means that if an investor had invested 100 million won at the peak, the value of their holdings would have shrunk to approximately 13.58 million won.

According to data from NH INVESTMENT & SECURITIES, as of the 16th, the average purchase price for individual investors in SAM CHUN DANG PHARM CO. LTD was approximately 448,441 won, and 94.6% of all investors are currently recording massive losses. If you had invested 100 million won at the March peak, your current portfolio value would have shrunk to the 13 million won range.

The trigger for the recent sharp fluctuations was an issue involving the U.S. Food and Drug Administration (FDA). On the 20th, the company announced that it had received a “Pre-ANDA” response from the FDA—a consultation process preceding the Abbreviated New Drug Application (ANDA) for an oral semaglutide generic—and the stock price immediately surged to the daily price limit (239,000 won). The company emphasized that the response specified Novo Nordisk’s “Rybelsus” as the reference listing drug (RLD) along with a meeting tracking number, stating that “regulatory uncertainty has been significantly alleviated.”

However, the stock failed to hold the daily price limit for even a single day. When the company refused to disclose the full text of the response, citing commercial confidentiality, the market lost the means to verify the basis for the claimed “reduction in uncertainty,” causing the stock to plummet to the daily price floor on the 21st. Lee Jae-won, an analyst at Yuanta Securities Korea, assessed, “By refusing to disclose the original text, market skepticism was reignited, causing the stock to give up the previous day’s gains.”

The problem is that the actual impact of this news falls far short of the impression suggested by its title. Above all, industry sources say that the FDA has drawn a clear line, significantly narrowing the scope for interpretation. According to industry sources, in response to the inquiry, the FDA stated, “Acceptance of a request for a pre-ANDA meeting does not imply a determination that the product is eligible for ANDA filing, nor does it confirm that the proposed development approach is acceptable.”