Korean oral obesity, insulin stock yo-yos on rumors

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Korean oral obesity, insulin stock yo-yos on rumors

Sam Chun Dang Pharm CEO Chun In-seok speaks on April 6 to address rumors surrounding the company’s recent stock dip at a press conference held at the company’s building in southern Seoul. [JOINT PRESS CORPS]

Sam Chun Dang Pharm CEO Chun In-seok speaks on April 6 to address rumors surrounding the company’s recent stock dip at a press conference held at the company’s building in southern Seoul. [JOINT PRESS CORPS]

 
Sam Chun Dang Pharm, once the top market-cap company on Korea’s Kosdaq driven by optimism over its oral insulin and obesity drug pipeline, said it has been “maliciously framed” after its stock plunged as doubts over its proprietary technology grew. 
 
The shares fell as much as 47.8 percent from their peak of 1.18 million ($786) won on Monday, fueled by rumors that its S-Pass drug delivery platform is further behind on development than what the company had claimed and lacks patent protection. Concerns also emerged that its oral semaglutide — a GLP-1 receptor agonist and the key ingredient in Novo Nordisk’s Wegovy — may still require large-scale clinical trials.
 
An anonymous blogger uploaded a post on March 30 that labeled the company's stock as rigged, raising suspicion about the validity of its S-Pass platform. Market fear further grew when an analyst from iM Securities questioned the feasibility of the company's U.S. licensing deal and that costly clinical trials are still needed for generic registration on U.S. Food and Drug Administration (FDA).
 
Sam Chun Dang Pharm CEO Chun In-seok speaks on April 6 to address rumors surrounding the company’s recent stock dip at a press conference held at the company’s building in southern Seoul. [JOINT PRESS CORPS]

Sam Chun Dang Pharm CEO Chun In-seok speaks on April 6 to address rumors surrounding the company’s recent stock dip at a press conference held at the company’s building in southern Seoul. [JOINT PRESS CORPS]

 
“The company has submitted materials to the FDA, S-Pass has an assigned patent number, and our oral semaglutide has received ANDA designation as a generic,” CEO Chun In-seok said Monday at a press conference at the company’s headquarters in southern Seoul, convened to address the snowballing rumors. ANDA, or Abbreviated New Drug Application, is the FDA approval of generic versions of existing drugs.
 
“These are official documents submitted to the FDA and the European Medicines Agency [EMA]. It would be impossible to proceed through regulatory processes with such stringent authorities using false technology,” he added.
 
Sam Chun Dang Pharm CEO Chun In-seok speaks on April 6 to address rumors surrounding the company’s recent stock dip at a press conference held at the company’s building in southern Seoul. [JOINT PRESS CORPS]

Sam Chun Dang Pharm CEO Chun In-seok speaks on April 6 to address rumors surrounding the company’s recent stock dip at a press conference held at the company’s building in southern Seoul. [JOINT PRESS CORPS]

 
A central point of contention was whether the company had provided solid evidence to support its claims that development of its technology and drug pipeline is progressing as planned. Sam Chun Dang argues that the FDA’s acceptance of its submission within the ANDA framework effectively indicates that the product is qualified as a generic drug.
 
“If the product were not eligible as a generic, the FDA would have directed us to a different regulatory track. Therefore, the current status can be viewed as equivalent to confirmation,” Chun said.
 
The company’s market value surged earlier this year, briefly making it the largest firm on the Kosdaq on March 20, when shares closed at 907,000 won, giving it a market capitalization of 21.27 trillion won. Investor enthusiasm was further fueled by a March 25 shareholder letter in which Chun said negotiations with a “global big pharma” partner were in the “final stages,” and hinted at imminent news that would “completely change the company’s weight class.”
 
At the annual general meeting on March 30, Chun highlighted the company’s S-Pass technology, which is a drug delivery platform designed to mimic Novo Nordisk’s SNAC mechanism by protecting peptide drugs from stomach acid, allowing it to absorb into the bloodstream.
 
The company’s two flagship programs based on S-Pass are oral insulin and oral semaglutide. Semaglutide is currently marketed by Novo Nordisk as injectable therapies such as Wegovy and Ozempic, as well as the oral formulation Rybelsus, which remains the only approved oral GLP-1 drug.
 
Chun also said the platform could be extended beyond weight-loss treatments to enable oral versions of antibody drugs and vaccines, a claim that helped drive the stock to a record high of 1.184 million won.
 
Sam Chun Dang Pharm CEO Chun In-seok attends a press conference on April 6 to address rumors surrounding the company’s recent stock dip at the company’s building in southern Seoul. [JOINT PRESS CORPS]

Sam Chun Dang Pharm CEO Chun In-seok attends a press conference on April 6 to address rumors surrounding the company’s recent stock dip at the company’s building in southern Seoul. [JOINT PRESS CORPS]

 
However, shares dropped about 30 percent the following day after the much-anticipated licensing deal for oral semaglutide products was revealed to be worth $100 million, which was smaller than market expectations, and the company declined to disclose the counterparty, so it is uncertain whether it’s a big pharma or not.
 
The stock plummet grew steeper after Chun disclosed plans on March 24 to sell shares worth 250 billion won to meet tax obligations, before canceling the plan on Monday.
 
Despite the volatility, Chun reiterated confidence in the company’s technology and development timeline.
 
“I want to personally demonstrate that a global innovator — on par with Eli Lilly or Novo Nordisk — can emerge from Korea,” he said. “Some may dismiss this ambition as unrealistic, but I hope to be remembered as someone who turned that bold vision into reality.”

BY LEE JAE-LIM [[email protected]]
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