"Not 'Samchundang' but 'Hwangcheondang'? Dramatic Reversal as Samchundang Pharmaceutical Hits Upper Limit After FDA Response"

'Upper Limit' Surge on Confirmation of FDA Development Process

Samchundang Pharmaceutical, which had been on a rapid downtrend due to controversies surrounding its technological substance, contract credibility, and research and development (R&D) infrastructure—earning the derogatory nickname "Hwangcheondang"—has now found a turning point. News that the company has received an official Pre-ANDA (pre-application meeting) response letter from the U.S. Food and Drug Administration (FDA) regarding the development of a generic oral semaglutide has led to a swift recovery in investor sentiment, sending its share price to the upper limit.

Samchundang Pharmaceutical headquarters building in Seocho-gu, Seoul. Samchundang Pharmaceutical

As of 11:00 a.m. on July 20, shares of Samchundang Pharmaceutical are trading at 239,000 won, up 29.8% from the previous session. The stock opened at 182,000 won that day and quickly expanded its gains, hitting the intraday price ceiling.

FDA Official Review Confirmed... Uncertainty in Development Eased

On this day, Samchundang Pharmaceutical announced that it had received a Pre-ANDA response letter from the FDA for its generic oral semaglutide application (ANDA), submitted in preparation for the formal approval process.

Pre-ANDA is an official procedure in the initial stage of generic drug development, in which matters such as the development strategy, reference listed drug (RLD), and bioequivalence (BE) study design are discussed in advance. According to Samchundang Pharmaceutical, this response letter confirmed that its development strategy is being formally reviewed under the FDA's ANDA process.

The reply included an ANDA meeting tracking number assigned by the FDA, and specified that the original drug, Rybelsus, is the reference listed drug (RLD). As a result, Samchundang Pharmaceutical believes that much of the regulatory uncertainty regarding its development pathway, previously raised in the market, has now been largely resolved.

'SNAC-Free' Strategy for Differentiation

Samchundang Pharmaceutical is advancing differentiated product development based on its proprietary platform technology. The oral semaglutide under development is based on its unique "S-PASS" platform and does not use the absorption enhancer SNAC, used in the original product—in other words, it is a SNAC-Free formulation.

Image to aid understanding of the article. Yonhap News TV

The original drug Rybelsus is protected by a formulation patent until 2039, which restricts market entry for competing products using the same technology. Samchundang Pharmaceutical aims to be the world's first to commercialize a SNAC-Free, oral semaglutide generic drug through its proprietary technology.

Repeating Sharp Rises and Falls... A Pivotal Moment for Investor Sentiment

Earlier this year, on the back of expectations for an "oral obesity treatment," the company's share price soared, making it a leading stock on KOSDAQ. At one point, its price surpassed 1 million won, earning it the status of a "blue chip" stock.

However, the stock price then plummeted as a series of issues emerged, including disputes over contract size, indications that additional clinical trials were needed, plans for large-scale share sales, and a prior notice designating the company as an unfaithful disclosure entity. Throughout this period, the derogatory nickname "Hwangcheondang" took hold online—a sign of sharply deteriorating investor sentiment.

The recent price surge and hitting the upper limit is meaningful as it represents a rebound amid this negative trend. The market has interpreted this as a clear signal of reduced regulatory risk and a start to reappraising the company's technological credibility.

However, some parties remain cautious. They note that, because further data collection and regulatory review are still required before final approval can be granted, the possibility of greater short-term volatility in the share price cannot be ruled out.

"The Stock Picked by Grandma"... SNS Meme Resurfaces

Alongside the rapid share price rise, the story of the so-called "Samchundang Grandma" is once again attracting attention. In February, a photo was posted on a social networking service (SNS) showing an elderly woman with white hair at a securities firm's customer desk, handing a slip of paper to an employee. On her note, she had neatly written the names of stocks and exchange-traded funds (ETFs) she wanted to buy—among them, "KODEX150 Leverage" and "Samchundang Pharmaceutical."

At that time, the stock price had already doubled from the end of the previous year, trading in the 500,000 won range. As a result, online commentators made sarcastic remarks such as, "If even grandma wants to buy, it's the sign of a market top."

Meme related to 'Samcheondang Grandma.' SNS screenshot

However, a month later, in March, when the share price doubled again to surpass 1 million won, reactions online shifted: "Grandma has a better eye than the professionals," and "She turned out to be the real market master," and the story spread as a meme.

This content was produced with the assistance of AI translation services.