[Edaily Reporter Song Young-doo] On the 16th, the pharmaceutical and biotech stock market saw a mixed performance among individual stocks as business momentum and shareholder returns intersected. Shares of HLB Group affiliates surged amid reports of an on-site inspection by the U.S. Food and Drug Administration (FDA) regarding their core pipelines. Ciers rose more than 10% on expectations of bed expansion and the fact that the number of hospitals adopting its AI inpatient monitoring platform, “thynC™,” has surpassed 200, while Algenomics also posted double-digit gains, buoyed by its decision to conduct a 100% bonus stock issuance.

Possibility Raised That Written Submission May Replace FDA Inspection for Riboceranib-Camrelizumab Combination Therapy

According to KG Zeroin MP Doctor (MP DOCTOR, formerly Marketpoint) on the 16th, #HLB Group stocks showed strong performance. Compared to the previous day, they rose as follows: △#HLB 6.26%(2,850 won), #HLB Pharmaceuticals by 9.85% (1,080 won), #HLB Life Sciences by 7.31% (225 won), #HLB Global by 6.00% (90 won), and #HLB Therapeutics by 5.25% (130 won).

The rise in HLB Group’s stock prices today is believed to have been influenced by speculation that the review of its key pipeline—the combination therapy of riboceranib and camrelizumab—may be concluded through a document review by the U.S. Food and Drug Administration (FDA) without an on-site inspection.

The riboceranib-camrelizumab combination therapy is a first-line treatment for liver cancer for which HLB’s U.S. subsidiary, Eleva Therapeutics, and Hangzhou Pharmaceutical are jointly seeking U.S. approval. In January of this year, the two companies resubmitted the New Drug Application (NDA) for riboceranib and the Biologics License Application (BLA) for camrelizumab. The FDA began the substantive review immediately upon receipt and set the Prescription Drug User Fee Act (PDUFA) target date for a final approval decision as July 23.

The market has identified the CMC (Chemistry, Manufacturing, and Control) validation of the camrelizumab manufacturing facility as the biggest variable in this review. This is because the combination therapy in question received a Complete Response Letter (CRL) on two separate occasions—in May 2024 and March 2025—due to issues with the manufacturing and quality control of camrelizumab.

According to HLB, Hangzhou Pharmaceutical has submitted all facility-related documents requested by the FDA and has not yet received any requests for additional documentation or notifications regarding an on-site inspection schedule. The company maintains that the mere fact that an on-site inspection has not yet taken place does not necessarily mean there will be delays in the approval schedule.

An HLB official explained to a media outlet, “Hangzhou Pharmaceutical has submitted all documents requested by the FDA and has not received any separate notification regarding an on-site inspection,” adding, “There are currently no new issues to disclose.”

In particular, the official noted, “It is a positive development that the FDA operates the RLI (Reports in Lieu of Inspection) system, under which it reviews documents and data submitted by the manufacturer to substitute for an on-site inspection, and there have been numerous recent cases of this,” but added, “At this stage, various possibilities remain until the FDA’s final decision, so we are calmly awaiting the outcome.”

In other words, industry analysts interpret this as suggesting that Hengrui Pharmaceutical—which faced issues during the approval review for the riboceranib and camrelizumab combination therapy—might be able to utilize this route, as the FDA operates a system that substitutes on-site inspections with document reviews. However, the industry believes it is unlikely that the FDA will actually replace Hengrui Pharmaceutical’s CMC inspection with a document submission.

Ciers Jumps 12%… Expectations for Bed Expansion as ‘thynC™’ Surpasses 200 Institutions

#Ciers, a wearable medical artificial intelligence (AI) company, saw its stock rise on news that the number of medical institutions adopting its AI inpatient monitoring platform “thynC™” has surpassed 200, as well as the recruitment of key talent. The market is focusing less on the mere increase in the number of hospitals adopting the platform and more on the strengthening of barriers to entry through bed expansion and the accumulation of operational data.

According to the Korea Exchange, Cears’ stock price closed at 32,300 won, up 12.15% (3,500 won) from the previous trading day. The rise in the stock price is attributed to the full-scale expansion of the thynC™ business and the strengthening of customer management capabilities. Ciers announced that the number of medical institutions adopting thynC™ had surpassed 200 and that it had recruited Director Jeong Hoon, formerly of global pharmaceutical company Daiichi Sankyo Korea, to enhance customer experience and operational systems.

Director Jeong is known as a healthcare expert with approximately 19 years of experience in sales, marketing, and medical affairs. In particular, he has experience building a network of medical staff at major university hospitals and tertiary general hospitals while overseeing the anticoagulant Lixiana business. The company expects these capabilities to contribute to strengthening Think’s hospital operational quality and customer management systems.

What investors are focusing on is not so much the number 200 itself, but the fact that operational references are accumulating rapidly. This is because AI-based inpatient monitoring solutions are highly likely to lead to algorithm refinement and increased trust among medical staff as they gain more real-world hospital operational experience and data.

A Ciers representative explained, “Think is not simply a business focused on increasing the number of hospitals where it is installed, but rather a platform that builds barriers to entry based on operational references.” They added, “As the number of participating medical institutions exceeds 200, operational know-how and AI data specific to each hospital are being accumulated, and this serves as the platform’s greatest competitive advantage in ensuring long-term adoption by hospitals.”

In fact, Think is expanding its scope of application to include integrated nursing and care wards, as well as internal medicine, cardiology, neurosurgery, VIP wards, and intensive care units. In particular, many tertiary general hospitals are expanding the system to additional wards following initial adoption, leading to simultaneous growth in the number of beds and the accumulation of operational data.

The market is paying close attention to the potential for this structure to drive future earnings growth. This is because as the number of beds increases, recurring usage fees and operational experience accumulate together, which could make it difficult for latecomer competitors to enter the market. Additionally, with the recruitment of external experts who possess hospital networks, there are expectations that customer management and the pace of new expansion will accelerate further.

A Ciers official stated, “The expansion of beds and the accumulation of operational data are creating a virtuous cycle,” adding, “Given the current trend, we view the growth outlook for the second quarter and beyond as positive.”

Algenomics: Investor Sentiment Strong Following Decision on 100% Stock Split

#Algenomics’ stock price surged after the company decided on a 100% stock split. On that day, Algenomics’ stock price rose 15.22% (13,500 won) compared to the previous day. This surge is believed to have been sparked by the board of directors’ decision the previous day to approve a stock split allocating one new share for every existing common share.

It is estimated that 14,027,718 new common shares will be issued through this stock split. Since the number of newly issued shares is identical to the total number of shares outstanding prior to the split (14,027,718 shares), the total number of outstanding shares will double to 28,055,436. The record date for the new shares is June 30; shareholders listed on the shareholder register as of that date will receive one additional share for every share they hold. The new shares are scheduled to be listed on July 21. The source of funds for the stock split is 7,013,859,000 won in share premium, and the board of directors approved the proposal the previous day with all two outside directors in attendance.

A stock split involves transferring the company’s retained earnings to capital to issue additional shares to shareholders free of charge. From the shareholders’ perspective, the number of shares they hold increases, but their ownership percentage remains unchanged. The company’s total value also remains theoretically unchanged. Nevertheless, there are three main reasons why investors pay close attention to stock splits.

First, trading liquidity increases as the number of shares in circulation rises. For stocks where trading was previously limited due to a high share price, the per-share price is effectively halved, improving accessibility for small investors.

Second, it is interpreted as a sign of financial strength. A stock split is possible only when there are sufficient internal reserves, such as retained earnings or share premium. In the case of Algenomics, the company utilized the share premium accumulated during its IPO as the funding source.

Third, the market perceives it as an expression of the company’s commitment to shareholder returns. Unlike cash dividends, it is often interpreted as a gesture that returns value to shareholders without an actual outflow of funds.

However, it is important to note that a stock split itself does not increase a company’s intrinsic value. Since the stock price theoretically drops to about half its level after the ex-split date due to the ex-split adjustment, experts generally advise that an assessment of the company’s fundamentals should take precedence over strategies aimed at short-term capital gains.

Algenomics is a KOSDAQ-listed biotech company developing RNA trans-splicing ribozyme-based gene therapies. Last year, the company secured a reference with a global big pharma player by signing a platform technology transfer agreement with Eli Lilly worth up to approximately 1.9 trillion won. Its core pipeline candidate, “RZ-001”—a gene therapy for liver cancer and glioblastoma—has received FDA Orphan Drug and Fast Track designations and is currently undergoing global clinical trials.