[Edaily Reporter KIM JI-WAN ] On the 25th, the domestic pharmaceutical sector showed a generally weak performance. The pharmaceutical sector index fell 0.45% from the previous day. Out of a total of 160 stocks, 34 rose, 13 remained unchanged, and 113 fell.

The life sciences sector saw an even sharper decline. The index fell 2.76%, and out of a total of 101 stocks, 13 rose, 13 remained unchanged, and 81 fell, with declining stocks overwhelmingly outnumbering the rest. However, some stocks bucked the market trend and posted gains based on individual positive developments.

ADBIOTECH Co.,Ltd.: Corporate Restructuring + Investment Inflow

ADBIOTECH Co.,Ltd. surged on expectations of

corporate restructuring

, an investment inflow of around 13 billion won, and the expansion of new business ventures. HK inno.N Corporation saw growing optimism regarding the U.S. commercialization of “K-Cap,” a new drug for gastroesophageal reflux disease. Prestige Biologics Co.,Ltd. saw rising expectations for consecutive CDMO orders and the expansion of commercial production.

ADBIOTECH Co.,Ltd.(179530)The stock price surged on expectations of growth driven by this corporate restructuring and the inflow of approximately 130억 won in investment funds.

According to KG Zeroin MP Doctor (MP DOCTOR, formerly Market Point) on that day, ADBIOTECH Co.,Ltd. closed at 2,310 won, up 391 won (20.38%) from the previous trading day. The company recently completed the payment for a third-party private placement and is accelerating management restructuring and the expansion of new businesses.

By completing a 13.2617 billion won rights offering, ADBIOTECH Co.,Ltd. has secured working capital and funds for business expansion. The largest shareholder, BK Partners Investment Fund No. 1, received an allocation of new shares, securing a stake of approximately 34.86%, and the fund’s largest investor has changed to LNJ Trust Holdings, resulting in changes to the company’s ownership structure.

The company has also decided to issue 3 billion won worth of private convertible bonds (CBs). The funds raised will be used for investments in new businesses and to strengthen the company’s operational foundation.

The management team has also been reorganized. At a recent board meeting, Kim Do-hyung, CEO of OnHill and a former veterinarian, was appointed as the sole CEO. CEO Kim is known for having led the founding of Notus (now HLBbioStep), a company specializing in non-clinical CRO services.

At the extraordinary general meeting of shareholders, proposals to add new business objectives—including biotech research and development (R&D), medical and healthcare, animal healthcare, and digital platforms—as well as the appointment of new board members were passed as originally proposed. The company plans to secure growth momentum by strengthening its existing immune antibody platform business while expanding its business scope to include companion animal healthcare and digital healthcare.

ADBIOTECH Co.,Ltd. stated, “We have strengthened our financial stability and foundation for business operations through a capital increase and organizational restructuring,” adding, “We will enhance the competitiveness of our existing immune antibody business while diversifying our portfolio into the biotech and digital healthcare sectors to increase our corporate value.”

HK inno.N Corporation: Expectations for Imminent U.S. Commercialization

Shares of HK inno.N Corporation rose as expectations grew for the U.S. commercialization of “K-Cap,” a treatment for gastroesophageal reflux disease (GERD) based on “ HK inno.N Corporation(195940)”—South Korea’s 30th domestically developed new drug.

On that day, HK inno.N Corporation closed at 39,700 won, up 2.58% (1,000 won) from the previous trading day. Analysts suggest that the company’s entry into the North American market is gaining momentum as its local partner has begun securing key manufacturing and quality assurance (QA/QC) personnel for the U.S. launch.

According to industry sources, Sequela—which holds the North American business rights for K-Cap—is currently recruiting a Quality Control (QC) Director to work at its subsidiary Braintree’s facility in Holbrook, Massachusetts. In the U.S. pharmaceutical industry, the Director level is considered a key executive-level position responsible for overseeing all aspects of manufacturing and quality.

According to the job posting, the QC Director will be responsible for ensuring compliance with the FDA’s current Good Manufacturing Practice (cGMP) standards, managing testing, responding to FDA inspections, and supporting commercial production and the introduction of new products. In addition, the company is also recruiting a Qualification of Manufacturing Equipment (CQV) Engineer and a Documentation Manager, who will be responsible for equipment qualification, managing manufacturing and quality documentation, and liaising with regulatory agencies.

The industry is paying close attention to this hiring because it could provide clues about K-Cap’s local production and supply strategy in the U.S. In particular, since the job posting explicitly mentions “FDA inspection response” and “commercial production support,” and given that BrainTree’s contract development and manufacturing organization (CDMO) facility is located in Holbrook—the designated work location—this lends credence to the interpretation that preliminary preparations for local production and launch following approval are already underway.

K-Cap is a new drug in the P-CAB (potassium-competitive acid blocker) class developed in-house by HK inno.N Corporation. It is marketed as having a faster onset of action than existing proton pump inhibitors (PPIs) and the convenience of being able to be taken regardless of mealtimes. In South Korea, its outpatient prescription sales exceeded 2000억 won last year, establishing it as a flagship product accounting for more than 20% of HK inno.N Corporation’s revenue.

Currently, “Voquezna” by Phathom is the only commercially available P-CAB product in the U.S. market. The product was developed by Takeda of Japan, and Phathom has secured the sales rights for the U.S., Europe, and Canada and is proceeding with its approval and commercialization.

However, HK inno.N Corporation has not yet officially disclosed how K-Cap will be manufactured and supplied as a finished product in the U.S. Although HK inno.N Corporation announced plans to supply raw materials for the U.S. market when it signed the contract with Sebela, it has not provided specific details regarding the production hub for the finished product or how the supply chain will be operated.

An HK inno.N Corporation official stated, “The U.S. business is being led primarily by Sebela,” adding, “It is difficult to disclose details regarding the production and supply system following approval at this time.”

Market outlook is also positive. According to market research firm IQVIA, the U.S. market for gastrointestinal ulcer treatments—including those for gastroesophageal reflux disease—was approximately $2.8 billion (about 4 trillion won) in 2021, and the industry expects it to grow to $5.7 billion (about 8.8 trillion won) by 2036.

Prestige Biologics Co., Ltd.: High Expectations for CDMO Business

Prestige Biologics Co., Ltd.(334970)’s stock price rose as the company fueled expectations for business expansion following a series of CDMO (Contract Development and Manufacturing Organization) order wins.

On that day, Prestige Biologics Co., Ltd. closed at 1,993 won, up 115 won (6.12%) from the previous trading day. The company announced that it had secured an additional order for the production of pre-commercial clinical samples from a domestic client with experience in global biosimilar commercialization.

This contract follows a new CDMO agreement recently signed with a major Asian pharmaceutical company. The identity of the contracting party and the specific products to be manufactured were not disclosed at the client’s request, and the contract term runs through the end of March 2027.

The production volume secured by the company is for a biosimilar project currently under development based on a global blockbuster drug. The product is reportedly nearing the commercialization stage, and Prestige Biologics Co., Ltd. expects that this clinical sample production will serve as a stepping stone to expand the scope of collaboration to include future commercial production.

As of the end of March this year, the company’s cumulative order backlog stood at approximately 65 billion won. Prestige Biologics Co., Ltd. explained that it has entered the stage of converting secured orders into actual production and revenue.

The company operates a production system that complies with the GMP standards of the Ministry of Food and Drug Safety (MFDS) and the European Medicines Agency (EMA), and has strengthened its quality control capabilities based on its experience in responding to inspections by global regulatory agencies.

Recently, the company has been focusing on its “Scale-Bridge CDMO” strategy, which provides continuous support from early-stage clinical production through commercial production. The company aims to build long-term partnerships with clients by reducing the burden of technology transfer and production risks that can arise as development stages change.

Efforts to improve profitability are also underway. The company stated that it has enhanced cost management efficiency by revising its existing structure—where raw material costs were previously recognized before revenue—and expects this to lead to improved operating profit in the future.

A Prestige Biologics Co., Ltd. official stated, “This follow-up order is a result of a client with global biosimilar commercialization experience once again recognizing our CDMO competitiveness,” adding, “We will leverage our experience in producing clinical samples to foster future commercial production partnerships and strive to expand repeat orders and strengthen our cost competitiveness.”