Samchundang Pharmaceutical and Kolon TissueGene led a sharp decline in pharmaceutical and biotech stocks on the KOSDAQ market, with Samchundang falling 27.41% to 173,500 won and Kolon TissueGene dropping 29.90% to 42,900 won as of 10:41 AM. The decline followed negative clinical trial results and regulatory clarifications that dampened investor sentiment. The pharmaceutical and biotech sector's weakness affected the broader KOSDAQ market, with foreign investors selling 67.1 billion won worth of stocks and institutional investors offloading 22.4 billion won.
Samchundang Pharmaceutical Drops 27.41% Following Regulatory Clarification
Samchundang Pharmaceutical fell 65,500 won (27.41%) to 173,500 won as of 10:41 AM, according to the Korea Exchange. The stock had reached a 52-week high of 1,233,000 won on March 30 before declining to approximately one-seventh of that level.
The company experienced extreme volatility. On the previous trading day, the stock hit the upper price limit after receiving a Pre-ANDA (Product Development Meeting) response letter from the FDA regarding official consultation procedures for a generic application of oral semaglutide. The stock reversed sharply after clarification emerged that the response letter did not confirm an approval pathway or exemption from additional clinical trials.
Kolon TissueGene Falls to Lower Limit After Phase 3 Clinical Trial Failure
Kolon TissueGene recorded 42,900 won, down 18,300 won (29.90%) from the previous day. The stock declined for three consecutive trading sessions and hit the lower price limit at market open. The decline followed news that the company's osteoarthritis gene therapy (TG-C, formerly Invossa) failed in Phase 3 clinical trials.
Kolon Life Science also fell to the lower price limit on the KOSDAQ market. Other biotech stocks showed weakness: Oncoceutics and Optus Pharmaceutical declined over 11%, Chaperone and IM Biomedics fell over 6%, and Ligachem Biosciences and Antrogenesis dropped over 5%. Among top market capitalization stocks, only Alteogen posted modest gains, while HLB and ABL Bio declined.
HLB Experienced Consecutive Lower Limits on Regulatory Setback
HLB hit the lower price limit for two consecutive days on the 10th and 13th. The company's U.S. subsidiary Eleva Therapeutics received a Complete Response Letter (CRL) from the FDA regarding its liver cancer drug approval application, with inspection-related issues identified during the review process.
Biotech Sector Decline Weighs on KOSDAQ Market
As pharmaceutical and biotech stocks constitute a core industry group on the KOSDAQ market, their decline negatively impacted the broader index. The KOSPI index showed weakness with a 1% decline. Foreign investors and institutions sold 67.1 billion won and 22.4 billion won worth of KOSDAQ stocks respectively. Financial investment firms and pension funds actively sold KOSDAQ stocks, indicating reduced institutional investor interest in the market.
Kim Sun-ah, a researcher at Hana Securities, stated: "The atmosphere is insensitive to positive news and only sensitive to negative news, with fundamentals completely ignored. Alteogen's stock price fell significantly on news of Epis' hyaluronidase development, but even after confirmation that the hyaluronidase is an Enhanze biosimilar contrary to the article, the current stock price remains at the level when it was shocked by MSD filing a Patent Grant Review (PGR) against Halozyme in November 2024."
FAQ
What caused Samchundang Pharmaceutical's 27.41% decline?
Samchundang Pharmaceutical fell 27.41% to 173,500 won after clarification emerged that the FDA's Pre-ANDA response letter did not confirm an approval pathway or exemption from additional clinical trials for its oral semaglutide generic application.
Why did Kolon TissueGene hit the lower price limit?
Kolon TissueGene fell to the lower price limit after news that its osteoarthritis gene therapy (TG-C, formerly Invossa) failed in Phase 3 clinical trials, causing investor sentiment to cool rapidly.
How much did foreign investors and institutions sell on the KOSDAQ market?
Foreign investors sold 67.1 billion won worth of KOSDAQ stocks, while institutional investors sold 22.4 billion won, with financial investment firms and pension funds actively exiting the market.
