pharm edaily

[Seungkwon kim, Edaily Reporter] The South Korea, domestic pharmaceutical, biotechnology and healthcare sector showed a mixed performance Wednesday, with companies expected to deliver promising clinical results or having high potential for technology exports seeing their share prices rise. While no stocks hit daily trading limits on the upside, companies with recognized value showed steady upward trajectories.

Ybiologics has maintained a sustained uptrend following its selection for a national project while LigaChem Biosciences appears to be influenced by news of clinical trials initiated by Daiichi Sankyo, a Japanese partner of Alteogen in antibody drug conjugate (ADC) development. Biobijou has also shown an upward trend, surpassing its initial public offering price gains since its first-half listing. Meanwhile, NatureCell hit the daily trading limit down following the regulatory rejection of its JointStem product approval.

Ybiologics share price trend (Image: MP DOCTOR)

Ybiologics Climbs Following National Project Selection

According to KG Zeroin‘s MPDOCTOR (formerly MarketPoint) Ybiologics closed trading Wednesday at 11,780 won, up approximately 9.48% from the previous day. The company’s market capitalization stands at about 176 billion won.

Ybiologics has seen trading volume surge since announcing that its proprietary next generation immuno oncology drug was selected as a national project securing total government funding of 5.8 billion won over the next four and a half years.

The selected project involves developing “manufacturing technology for innovative therapeutic substances that fuse cytokines with dual antibodies that simultaneously block two immune checkpoints, including PD-1.”

Ybiologics is developing a “dual antibody cytokine fusion” platform based on its proprietary PD-1 antibody “acrelizumab,” which combines immune-activating antibodies with cytokines. The strategy aims to expand treatment targets to include cancer patients who do not respond to existing immune checkpoint inhibitors or experience recurrence.

The global blockbuster drug Keytruda (pembrolizumab) has established itself as a standard treatment with excellent therapeutic effects across various cancer types but has limitations with response rates of only about 30% when used alone. The remaining 70% of patients experience treatment resistance or recurrence prompting ongoing efforts in the pharmaceutical and biotechnology industry to overcome these challenges. This project aims to develop next generation immuno oncology drug manufacturing technology that dramatically improves the efficacy limitations of existing PD-1 or PD-L1 antibodies, with the goal of advancing to Phase 1 clinical trials.

Ybiologics recently transferred immuno oncology antibody technology to LigaChem Biosciences. The antibody is being applied to LigaChem’s antibody-drug conjugate (ADC) pipeline for joint development.

“Recent clinical results are proving the superiority of dual antibodies but there remains enormous unmet medical need for refractory and recurrent cancers,” said a Ybiologics representative.

“We plan to accelerate the development of dual antibody cytokine fusions to provide new treatment options for patients who do not benefit from existing immuno oncology drugs.”

LigaChem Biosciences Gains on Technology Export Expectations

LigaChem Biosciences acquired by the Orion Group is a top market capitalization company leading “K-Bio” alongside Alteogen. LigaChem Biosciences’ shares closed Wednesday at 149,500 won, up approximately 8%, with a market capitalization of about 5.47 trillion won.

The recent uptrend appears to be driven by expectations for additional technology exports, along with the influence of Alteogen’s ADC partner Daiichi Sankyo initiating clinical trials for the subcutaneous (SC) formulation of breast cancer treatment Enhertu. The opening of a full scale ADC SC formulation era in the industry would be positive news for LigaChem as an ADC developer.

This has made LigaChem Biosciences the stock with the highest foreign net buying for several consecutive days. The company ranked high for the second consecutive day following the previous day. Both institutional and foreign buying appear to be concentrated, with trading volume surging alongside expectations for new drug development.

LigaChem Biosciences announced last month its vision to secure more than 20 ADC platform-based pipeline projects within 2~3 years. This represents four times the current five ongoing research projects building on previously achieved technology exports. Having already built market trust through more than 10 cumulative technology exports, the company’s stock price hit an intraday all time high of 156,200 won on July 18 following the company‘s announcement.

Biobijou which went public on the KOSDAQ market in the first half of the year, also shows steady upward momentum. Biobijou closed Wednesday at 19,230 won, up about 7%.

Biobijou signed a memorandum of understanding (MOU) last month with stem cell new drug development specialist Medino for “joint development and sales of next-generation medical devices and bio new materials” generating expectations.

The companies agreed to expand networks and pursue joint marketing in key Asian markets particularly China and Japan to increase market share and explore mutual investment options for long term cooperative relationships when necessary.

“Biobijou, which has grown by developing differentiated medical aesthetic products in the global market is confident that this business agreement will secure new growth drivers” the company stated.

NatureCell share-price trend (Image: MP DOCTOR)

NatureCell Plunges on Third Regulatory Rejection

Meanwhile, some companies showed significant declines in the market Wednesday. NatureCell was the main casualty. NatureCell hit the daily trading limit down as its arthritis stem cell therapy “JointStem” once again failed to clear the regulatory approval threshold. The company’s shares traded at the daily limit down of 24,750 won (down 29.89%) immediately after the morning opening, plunging 10,500 won from the previous trading day.

The Korea Food and Drug Administration (KFDA) officially notified Alveolix of “JointStem product approval rejection” at around 6:45 p.m. on Tuesday (August 5), which NatureCell reflected in a corrective disclosure after market close.

JointStem is an autologous cell therapy using adipose-derived adult stem cells, targeting pain relief and functional improvement in degenerative arthritis patients. NatureCell signed an exclusive domestic sales agreement with developer Alveolix in 2013, and would hold sales rights for 10 years if the therapy receives product approval.

This rejection marks JointStem‘s third approval failure. Alveolix first applied for conditional approval in 2018 but was rejected, then applied for formal product approval in 2021 but received a second rejection notice in 2023. After submitting supplementary data and reapplying in March last year, it faced rejection again for the same reason: insufficient clinical significance.

The KFDA held a pharmaceutical review committee meeting in June to discuss safety, efficacy, and approval considerations, ultimately concluding it was difficult to confirm significant differences in the treatment group compared to the control group.