[Kim Sungjin, Edaily Reporter] South Korea’s pharmaceutical and biotech stocks posted mixed results on Oct. 8, with Peptron plunging nearly 30% after its technology evaluation with Eli Lilly concluded without a follow-on commercialization deal, while Hanmi Pharmaceutical fell 10% despite receiving approval for South Korea’s first domestically developed GLP-1 obesity drug. Meanwhile, shares of HLB Group companies continued to surge as regulatory uncertainty surrounding rivoceranib eased following the U.S. approval of another HLB drug.

Peptron Plunges as Hopes for Lilly Collaboration Fade

According to KG Zeroin’s MP DOCTOR, Peptron closed at 91,500 won, down 39,100 won, or 29.94%, from the previous session. The stock had already plunged 25.8% in after-hours trading after the company announced that its technology evaluation with Eli Lilly for its long-acting drug delivery platform, SmartDepot, had ended.

Peptron’s shares continued to fall after the market opened, approaching the daily lower limit around 11 a.m.

Peptron and Lilly signed a technology evaluation agreement in October 2024 to assess whether SmartDepot could be applied to peptide drugs owned by Lilly. The evaluation period, initially set at 14 months, was extended to as long as 24 months in December of last year before ending on Oct. 7.

The market had anticipated that the evaluation would lead to a licensing or co-development agreement.

SmartDepot uses biodegradable polymers such as PLGA to form microspheres containing peptide drugs, allowing the drugs to be released gradually in the body. The technology is designed to extend dosing intervals for drugs that are typically administered daily or weekly, potentially enabling monthly dosing.

The platform drew particular attention because Lilly is rapidly expanding its presence in the obesity drug market with Mounjaro and Zepbound.

However, no commercialization agreement was announced when the evaluation concluded. Peptron said in a statement on October 7 that it was “taking seriously” the fact that it could not announce a follow-on commercialization agreement at the end of the evaluation period.

The company nevertheless emphasized that the joint research and technology evaluation had been completed as planned and that it had received all payments stipulated under the agreement.

As investor concerns persisted, Peptron issued another statement on the morning of Oct. 8, stating that the absence of a commercialization agreement at the end of the evaluation should not be interpreted as meaning that a follow-on deal had “failed.”

Concerns are also mounting regarding Peptron’s financial burden as it expands production capacity in anticipation of commercialization.

Last month, Peptron announced plans to build a second plant at its Osong Bio Park in Cheongju, North Chungcheong Province, under a construction contract with GCEM. The facility is scheduled for completion on February 15, 2028, with construction costs totaling 89 billion won.

Since Peptron has yet to turn a profit, investors are concerned that the additional production capacity could increase the company’s financial burden if it fails to secure commercial orders for SmartDepot.

Hanmi Falls 10% Despite Approval of First Domestically Developed GLP-1 Obesity Drug

Hanmi Pharmaceutical also saw its shares fall sharply despite receiving regulatory approval for Efe, South Korea’s first domestically developed GLP-1 obesity drug.

Hanmi Pharmaceutical closed at 480,500 won, down 53,500 won, or 10.02%, from the previous session.

The Ministry of Food and Drug Safety approved Hanmi’s Efe Auto-Injector, which contains the active ingredient efpeglenatide, on October 7, paving the way for its commercial launch. The stock, however, moved in the opposite direction.

Efpeglenatide is South Korea’s 45th domestically developed new drug and the first GLP-1 obesity treatment independently developed by a Korean pharmaceutical company.

The approved doses are 2, 4, 6, 8, and 10 milligrams. In a Phase 3 trial involving 448 Korean adults with obesity, patients achieved an average weight reduction of 9.75% after 40 weeks of treatment.

Efe is indicated for chronic weight management in adults who are obese or overweight but do not have diabetes. It is administered as an injection in conjunction with a reduced-calorie diet and exercise. By activating GLP-1 receptors located in the central nervous system and gastrointestinal tract, the drug suppresses appetite and delays gastric emptying, thereby increasing satiety and promoting weight loss.

Hanmi aims to launch the drug later this year. The company is expected to compete with Novo Nordisk’s Wegovy and Lilly’s Mounjaro in the Korean obesity treatment market by offering a relatively lower price.

Wegovy currently sells for roughly 200,000 to 400,000 won per month depending on the dosage, while Mounjaro costs about 300,000 to 600,000 won.

The decline in Hanmi’s stock price is largely attributed to profit-taking, as the approval had already been factored into the stock price. Shares had traded in the low 300,000-won range in late July before rising steadily to above 500,000 won.

Hanmi is also seeking to expand Efe’s indications and is currently conducting a Phase 3 trial to evaluate the drug as a treatment for diabetes.

HLB Affiliates Surge as Rivoceranib Uncertainty Eases

Shares of HLB Group affiliates continued to surge following the U.S. approval of HLB’s cholangiocarcinoma drug Ripictu, whose active ingredient is lirafugratinib. Expectations of another U.S. regulatory challenge for rivoceranib are also providing additional momentum.

According to KG Zeroin’s MP DOCTOR, three HLB affiliates—HLB bioStep, HLB Panagene, and HLB Global—reached their daily upper price limits.

HLB bioStep rose 1,455 won to close at 6,310 won, while HLB Panagene gained 409 won to 1,774 won. HLB Global advanced 605 won to 2,635 won. Smaller HLB affiliates generally saw larger price swings.

The rally reflects improving prospects for HLB’s drug development and regulatory pipeline. HLB announced on September 23 that the U.S. Food and Drug Administration had approved Ripictu, marking the first time a drug developed by a Korean company had received FDA approval as an anticancer treatment.

HLB is also working to expand Ripictu’s presence in Europe. On Oct. 7, the company announced that the European Medicines Agency had begun reviewing its marketing authorization application.

The company is also pursuing development programs aimed at expanding the drug’s use beyond cholangiocarcinoma to other solid tumors.

Meanwhile, expectations are growing that HLB could make another attempt to secure U.S. approval for rivoceranib, its liver cancer drug that has been in development for roughly two decades.

The drug has faced setbacks after receiving three complete response letters from the FDA. A key issue was deficiencies identified during inspections of manufacturing facilities operated by HLB’s Chinese partner, Hengrui Pharmaceuticals, including facilities for active pharmaceutical ingredients and finished products.

The matter was recently resolved with a “Voluntary Action Indicated” (VAI) classification, alleviating some of the regulatory uncertainty surrounding a potential resubmission.