[Edaily Reporter Minji Son ] From July 20 to 24, the pharmaceutical and biotech industry was rocked by news that Kolon TissueGene, Inc.(950160)failed to achieve statistical significance in the U.S. Phase 3 clinical trial of its osteoarthritis treatment “TG-C” (formerly Invossa). Meanwhile, SAMSUNG BIOLOGICS(207940)drew attention with news that it is expanding its business portfolio by acquiring a global peptide contract development and manufacturing organization (CDMO).

Kolon TissueGene, Inc. Fails to Demonstrate Efficacy in First U.S. Phase 3 Trial of TG-C

Kolon TissueGene, Inc. announced on the 20th that TG-C, a cell-gene therapy for knee osteoarthritis, failed to meet the co-primary endpoint in the first top-line results from its U.S. Phase 3 clinical trial. Although pain relief and improved joint function were observed in the TG-C treatment group, similar levels of improvement were also seen in the placebo group, resulting in no statistically significant difference between the two groups.

In fact, the pain index (VAS) in the TG-C treatment group improved by 38.7 points compared to pre-treatment levels, and the World Health Organization Osteoarthritis Index (WOMAC) composite score for joint function and pain also decreased by 27.61 points. However, the VAS and WOMAC scores in the placebo group also improved by 39.2 points and 26.54 points, respectively, showing changes similar to or even greater than those in the TG-C treatment group.

Nevertheless, Kolon TissueGene, Inc. maintains that it is difficult to conclude the trial was a failure. This is because the TG-C group itself replicated the pain and functional improvements seen in previous clinical trials. Jeon Seung-ho, CEO of Kolon TissueGene, Inc., described these results as a “half-success” during a press conference held on the 21st and expressed his intention to continue development.

The future direction of development hinges on the results of the second U.S. Phase 3 clinical trial, which will be released in October. The company plans to analyze the results of the second trial before discussing its marketing authorization strategy with the U.S. Food and Drug Administration (FDA). However, since the first trial failed to demonstrate efficacy, the originally targeted timeline—a Biologics License Application (BLA) submission next year and commercialization in 2028—is now likely to be delayed.

SAMSUNG BIOLOGICS Invests 2.7 Trillion Won… Enters Obesity Drug CDMO Market

On the same day, SAMSUNG BIOLOGICS announced that it would acquire the Swiss peptide CDMO company Polypeptide Group for approximately 2.7 trillion won. This marks the largest merger and acquisition (M&A) deal in South Korea’s pharmaceutical and biotech industry. SAMSUNG BIOLOGICS plans to secure 100% ownership of Polypeptide Group through the acquisition of shares from major shareholders and a tender offer, with the transaction expected to be finalized by the end of the year.

Polypeptide Group is a global CDMO specializing in the development and production of peptide-based active pharmaceutical ingredients (APIs). With over 70 years of production experience, it has developed and produced more than 1,000 therapeutic peptides and operates six production facilities across five countries, including Sweden, Belgium, France, India, and the United States.

SAMSUNG BIOLOGICS plans to take over the CDMO contracts and customer base currently managed by the Polypeptide Group to secure revenue immediately following the acquisition. This is interpreted as a strategy to shorten the time to market by acquiring a company with global technology, customers, and production hubs, rather than building new production facilities from scratch.

With this acquisition, SAMSUNG BIOLOGICS’ business portfolio will expand to include messenger RNA (mRNA), antibody-drug conjugates (ADCs), and peptides, in addition to its existing core business of antibody drugs. In particular, peptides—which serve as key active ingredients in glucagon-like peptide-1 (GLP-1) class treatments for obesity and diabetes—are seeing rapidly growing demand. With this acquisition, SAMSUNG BIOLOGICS is also making a full-scale entry into the growing peptide drug CDMO market, centered on obesity and diabetes treatments.

Heo Hye-min, an analyst at KIWOOM Securities, stated, “The success of the acquisition is expected to hinge on factors such as future profit margin dilution, the commercialization of the Phase 3 pipeline, the expansion of GLP-1-related volumes, and cross-orders from clients.” She added, “We view this transaction as a strategic move to simultaneously secure peptide technology, talent, clients, and a proven track record, which we believe will positively contribute to the company’s mid- to long-term growth.”