[Edaily Reporter KIM SUNG-JIN ] On the 6th, in the biotech sector, the stock prices of affiliates of the HLB INC.(028300) Group—which received South Korea’s first-ever approval from the U.S. Food and Drug Administration (FDA) for a new anticancer drug—rose across the board. In particular, HLB PHARMACEUTICAL(047920)and HLBbioStep(278650)both hit their daily price limits.

SAM CHUN DANG PHARM CO. LTD(000250), whose stock price had plummeted due to successive delays in key pipeline schedules and controversies over regulatory disclosures, has seen its stock price rise for five consecutive trading days, drawing attention to the reasons behind this trend.

HLB PHARMACEUTICAL and HLBbioStep

Hit Daily Price Limits…

Will Riboceranib Follow in the Footsteps of Lyrfigtu?

According to KG Zeroin’s MP DOCTOR on that day, HLB PHARMACEUTICAL’s stock price rose 3,000 won (29.97%) from the previous trading day, hitting the daily price limit. After news broke that HLB INC.’s new bile duct cancer drug “Lyrfigtu” (LYRFIGTU) had received FDA approval, the stock hit the daily price limit for two consecutive days before entering a downtrend; however, the stock price surged again today.

Affiliate HLBbioStep also hit the daily price limit. Its stock price rose 860 won (29.91%) from the previous trading day to close at 3,735 won. In addition, the stock prices of the group’s major affiliates— HLB Life Science(067630)(25.03%), HLB GLOBAL Co., Ltd.(003580)(16.88%), HLB INC. (16.81%), and HLB Therapeutics(115450)(15.99%)—all surged simultaneously.

HLB INC.’s stock surge is attributed to the FDA approval of Refictu. Refictu is a new drug that HLB INC.’s U.S. subsidiary, Eleva Therapeutics, acquired through a technology transfer from U.S.-based Relay Therapeutics in December 2024; Eleva plans to launch the product in the U.S. during the fourth quarter of this year.

This marks the first time a South Korean company has received FDA approval for a new anticancer drug, and HLB INC. is drawing significant industry attention for having independently managed the process from securing the rights to Ripicto through to FDA approval. Some observers are even saying that this has opened a new chapter for the domestic new drug development market.

With HLB INC.’s successful approval of Rifictu, industry attention is now turning to its next drug development project. Riboceranib, which HLB INC. has spent nearly 20 years developing, is widely regarded as the leading candidate for its next anticancer drug.

Although Riboceranib is a new liver cancer drug that HLB INC. has been developing for about 20 years, it received three Complete Response Seohans (CRLs) from the FDA, raising concerns about the feasibility of its development. Issues identified during a cGMP (Current Good Manufacturing Practice) inspection of the manufacturing facilities (active pharmaceutical ingredients and finished drug products) of its partner, China’s Hangzhou Pharmaceutical, also contributed to the third CRL.

However, these concerns appear to be easing somewhat. HLB PHARMACEUTICAL announced today that the FDA classified its routine cGMP inspection of the manufacturing facility for the finished riboceranib product as a “Voluntary Action Recommendation (VAI).” Previously, on the 3rd, Hangzhou Pharmaceutical, a partner of Eleva, also received a Seohan of inspection completion.

A VAI is a classification assigned when, although some findings were identified during an FDA inspection, the agency determines that no separate formal regulatory action is necessary because the company can voluntarily correct them. Eleva is currently working with Hangzhou Pharmaceutical to finalize the documentation required for the resubmission of the New Drug Application (NDA) for a new liver cancer treatment.

An HLB PHARMACEUTICAL official stated, “This VAI classification is the result of Hangzhou Pharmaceutical’s proactive response, in which it concentrated its company-wide resources to resolve the issues identified during the inspection,” adding, “Eleva will work closely with Hangzhou Pharmaceutical to swiftly finalize preparations for the resubmission of the NDA for the new liver cancer drug and will proceed without a hitch in the subsequent FDA review.”

SAM CHUN DANG PHARM CO. LTD Up 49% Over 5 Trading Days… “No Specific Reason for the Rise”

The sharp rise in SAM CHUN DANG PHARM CO. LTD’s stock price was also one of the notable events in the biotech sector that day. According to KG Zeroin’s MP DOCTOR, SAM CHUN DANG PHARM CO. LTD’s stock price rose by 34,500 won (16.67%) compared to the previous trading day, closing at 241,500 won.

SAM CHUN DANG PHARM CO. LTD’s stock price has risen for five consecutive trading days. The share price, which stood at 162,300 won per share on the 28th of last month, has surged by a staggering 48.8% in just five trading days.

SAM CHUN DANG PHARM CO. LTD recently announced plans to expand its age-related macular degeneration (AMD) treatment business—established with Canada’s Apotex—from a single biosimilar to a portfolio of multiple products. The key focus is to add new AMD treatments following the commercialization in Canada of its existing Eylea biosimilar, “SCD411.”

Additionally, starting today, SAM CHUN DANG PHARM CO. LTD is participating for the first time with its own booth at “CPHI Worldwide,” a global pharmaceutical industry exhibition taking place in Milan, Italy. At this event, SAM CHUN DANG PHARM CO. LTD plans to unveil its pipeline of products currently in development, including oral insulin, oral GLP-1, long-acting injectables, and biosimilars for immuno-oncology.

However, regarding this week’s stock price rise, a SAM CHUN DANG PHARM CO. LTD official stated, “Stock prices are determined by the market, so it is difficult for the company to comment specifically,” adding, “The company is focusing on its ongoing business.”

Alteogen Inc. Secures 200 Billion Investment and Merges Subsidiary… Stock Price Remains Steady

Alteogen Inc.(196170)Although Alteogen Inc. announced that it would secure 200 billion won in investment from the Kookmin Growth Fund and SkyLake, its stock price showed little movement. According to KG Zeroin MP DOCTOR, Alteogen Inc.’s stock price is trading in the after-hours market at a level 4,500 won (1.73%) higher than the previous trading day’s close.

Alteogen Inc. announced today that it will issue a total of 200 billion won in preferred stock, with SkyAlt—a company established through a joint venture between the Kookmin Growth Fund and SkyLake—serving as the acquirer. This investment round will be carried out by issuing 100 billion won in convertible preferred stock (CPS) and 100 billion won in redeemable convertible preferred stock (RCPS).

Through this investment, Alteogen Inc. plans to expand its production capacity based on the current business performance of ALT-B4 while securing new pipeline candidates to diversify its business portfolio. ALT-B4 is the core substance of Alteogen Inc.’s subcutaneous injection formulation modification platform, Hybrozyme. MSD’s Keytruda subcutaneous injection formulation, which utilizes ALT-B4, has been approved and launched in the U.S., Europe, Canada, South Korea, and Japan.

Alteogen Inc. also announced today that it will merge with its subsidiary, Alteogen Biologics, through a merger by absorption. The merger will take the form of a small-scale merger, with Alteogen Inc. remaining as the surviving company and Alteogen Biologics ceasing to exist after the merger.

Until now, Alteogen Inc. has been responsible for research and development and production, while Alteogen Biologics has handled clinical trials, regulatory approvals, and marketing. Alteogen Inc. explained the reason for the merger, stating, “There was complexity in the management structure between the two companies regarding product supply and the settlement of development costs. This complexity posed risks such as delays in decision-making and inefficient resource allocation during urgent business initiatives—such as the commercialization of the Eylea biosimilar (ALT-L9) and the overseas expansion of Tergaze—as well as risks related to securing development funding for pipelines under independent development.”

An Alteogen Inc. official said, “We aim to secure new pipelines, such as ALTS-OP01—a new drug for the treatment of xanthin deposition disease—and enhance our development capabilities. By internalizing the domestic and international sales and marketing personnel and know-how held by Alteogen Biologics, we will reduce the time and burden of having to build a sales organization from scratch when commercializing our in-house developed products in the future, and instead leverage the existing organization and experience.”

Alteogen Inc. announced on the same day that it would issue preferred stock totaling 200 billion won to SkyAlt, an acquirer established through a joint investment by the National Growth Fund and SkyLake. This capital raise will be conducted by issuing 100 billion won in convertible preferred stock (CPS) and 100 billion won in redeemable convertible preferred stock (RCPS).

Through this investment, Alteogen Inc. plans to expand its production capacity based on the current business performance of ALT-B4 while securing new pipeline candidates to diversify its business portfolio. ALT-B4 is the core compound of Alteogen Inc.’s Hybrozyme platform for subcutaneous injection formulation modification. MSD’s Keytruda subcutaneous injection formulation, which incorporates ALT-B4, has been approved and launched in the U.S., Europe, Canada, South Korea, and Japan.