[Edaily Reporter KIM SUNG-JIN ] On the 8th, in the domestic pharmaceutical and biotech market, shares of Peptron, Inc.(087010)fell sharply as hopes for a partnership with global pharmaceutical company Eli Lilly faded, while HanmiPharm(128940)also saw a significant drop despite receiving approval for Korea’s first domestically developed obesity drug. In contrast, HLB Group shares continued their strong rally after receiving approval from the U.S. Food and Drug Administration (FDA) for a new bile duct cancer drug, as some of the uncertainty surrounding riboceranib was resolved.

Expectations for Lilly Collaboration Dampened… Financial Burden Also a Concern

According to KG Zeroin’s MP Doctor on that day, Peptron, Inc.’s stock price closed at 91,500 won, down 39,100 won (29.94%) from the previous trading day. Following news after the close of regular trading the previous day that the technical evaluation of “SmartDepo,” a long-acting drug delivery platform developed in collaboration with Eli Lilly, had concluded, the stock plummeted by 25.8% in after-hours trading. On this day, the stock price began to fall sharply right from the market open and converged toward the daily price limit down around 11:00 a.m.

Peptron, Inc. and Lilly signed a technical evaluation agreement in October 2024 to determine whether the SmartDepo platform could be applied to Lilly’s peptide drugs. The evaluation period, originally set at 14 months, was extended to a maximum of 24 months last December, and the agreement concluded on the 7th of this month. Ahead of the evaluation’s conclusion, the market had been growing increasingly optimistic about the possibility of a follow-up licensing agreement or joint development agreement being signed.

Peptron, Inc.’s SmartDepo is a long-acting drug delivery technology that uses peptide drugs and the biodegradable polymer PLGA to create microspheres, enabling the drug to be released slowly within the body. It has garnered significant attention for its ability to extend the dosing interval for drugs that must be administered daily or weekly to as infrequently as once a month. In particular, as Lilly has been expanding its influence in the obesity treatment market with drugs like Mounjaro and Zepbound, market interest has focused on the potential for a partnership with Peptron, Inc.

However, by the time the technology evaluation concluded, the anticipated commercialization agreement had not been announced. In response, Peptron, Inc. issued a statement on the 7th, stating, “The company takes it very seriously that we were unable to announce the signing of a follow-up commercialization agreement at the conclusion of the technology evaluation period,” while adding, “The joint research and technology evaluation between the two companies were completed normally within the contract period, and we have received all payments stipulated in the technology evaluation agreement. All joint research and contractual procedures were properly carried out and completed.” As the market reaction remained lukewarm—with the stock price falling sharply despite this announcement—the company issued another statement that morning, stating, “Although a follow-up commercialization agreement was not signed at the conclusion of the technology evaluation, it is inappropriate to interpret this as the follow-up commercialization agreement having ‘fallen through.’”

The issue is that Peptron, Inc. has already begun expanding its production facilities with the goal of commercializing SmartDepo. On the 3rd of last month, Peptron, Inc. announced that it had signed a construction contract with GC Biopharma Corp. to build its second plant at Osong Bio Park in Cheongju, North Chungcheong Province. The plant is scheduled for completion on February 15, 2028, with a total construction cost of 89 billion won. Peptron, Inc. is not yet a profitable company, and concerns have been raised that its financial burden from building additional production facilities will increase if it fails to secure future orders.

HanmiPharm Faces Lukewarm Market Reaction Despite Approval of First Domestic Obesity Drug HanmiPharm

’s stock price fell sharply

despite receiving approval for

“Epe,”

the first domestically developed

GLP-1-based

obesity drug

. HanmiPharm’s stock closed at 480,500 won, down 53,500 won (10.02%) from the previous trading day. Although the Ministry of Food and Drug Safety approved HanmiPharm’s “Epe Autoinjector” (active ingredient: efeglenatide) the previous day, signaling the green light for the product’s launch, the stock price moved in the opposite direction.

Epe glenatide is the 45th new drug developed in South Korea and the first GLP-1-based obesity treatment independently developed by a domestic pharmaceutical company. The approved dosages include 2, 4, 6, 8, and 10 mg. A Phase 3 clinical trial involving 448 obese Korean adults confirmed an average weight loss of 9.75% after 40 weeks of treatment.

Epe is an injectable medication for the chronic weight management of obese and overweight adults without diabetes. It is used in conjunction with a low-calorie diet and exercise therapy. It induces weight loss by activating GLP-1 receptors distributed throughout the central nervous system and gastrointestinal tract, thereby suppressing appetite and delaying gastric emptying to increase feelings of fullness.

HanmiPharm aims to launch the drug by the end of the year. It is expected to leverage its relatively low price as a competitive advantage in the domestic obesity treatment market, which is currently dominated by Wegovy and Mounjaro. Currently, the monthly sales price for Wegovy ranges from 200,000 to 400,000 won depending on the dosage, while Mounjaro ranges from 300,000 to 600,000 won.

The reason for the stock price decline despite this positive news is believed to be the impact of the recent rise in the stock price driven by expectations for the new drug’s approval. The stock price, which had remained in the low 300,000 won range at the end of July, showed a steady upward trend and even exceeded 500,000 won at one point.

HanmiPharm is also pursuing an expansion of Epe’s therapeutic indications. The company is currently conducting a Phase 3 clinical trial to expand its indications for the treatment of diabetes.

HLB INC. Affiliates Show Strong Gains as Uncertainty Surrounding Riboceranib Eases

The stock prices of

HLB

INC

. affiliates

have continued to show

strong gains

following the FDA approval of the new bile duct drug Ripictu (active ingredient: lirapugratinib). Growing expectations for a renewed attempt to secure U.S. approval for Riboceranib appear to be providing additional momentum for further gains.

According to KG Zeroin MP Doctor, three HLB affiliates— HLBbioStep(278650), HLB PANAGENE(046210), and HLB GLOBAL Co., Ltd.(003580) —hit their daily price limits on the day. HLBbioStep closed at 6,310 won, up 1,455 won, while HLB PANAGENE rose 409 won from the previous day to 1,774 won. HLB GLOBAL Co., Ltd. closed at 2,635 won, up 605 won. Overall, subsidiaries with smaller market capitalizations showed the greatest volatility in their stock prices. HLBbioStep alone hit the daily price limit for three consecutive trading days, more than doubling its share price from below 3,000 won.

The strong performance of HLB INC. affiliates’ stock prices is attributed to positive developments in new drug development and approval. HLB INC. announced late last month, on the 23rd (local time), that it had received FDA approval for Ripictu. Ripictu is the first anticancer drug developed by a Korean company to receive FDA approval, and it is regarded as a milestone for the domestic new drug development industry. HLB INC. is also accelerating its efforts to enter the European market with Ripictu. On the 7th, HLB INC. announced that the European Medicines Agency (EMA) had begun reviewing Ripictu’s marketing authorization application. Currently, HLB INC. is also conducting development to expand the treatment scope from cholangiocarcinoma—a market with a somewhat limited size—to other solid tumors.

In addition, expectations for a renewed attempt to secure U.S. approval for Riboceranib are cited as a factor driving the stock price higher. Riboceranib is a new liver cancer drug that HLB INC. has been developing for about 20 years, but its progress was halted after receiving three Complete Response Letters (CRLs) from the FDA. In particular, the issue stemmed from concerns raised during a cGMP (Current Good Manufacturing Practice) inspection of the manufacturing facilities (for active pharmaceutical ingredients and finished dosage forms) of its partner, China’s Hangzhou Pharmaceutical. However, uncertainty has been significantly alleviated as the matter was recently resolved through a “Voluntary Action Recommendation (VAI).”