## Biotech King Stock Faces FDA Approval but Cold Reception; Insider Selling Reveals Market Reality

A company once hailed as a biotech star has recently fallen into trouble. This company, 康霈\*, which was included as a constituent of Taiwan's Top 50 Index not long ago, experienced a series of limit-downs after its mid-September earnings call. Its stock price dropped from NT$229.5 to NT$207 within two trading days, with a market cap shrinking by over NT$40 billion, and over 30,000 shares being sold on the limit-down boards.

The trigger for the event was a regulatory recommendation. The company's core product, the weight-loss injection CBL-514, faced delays in its Phase 3 clinical trial in the US. The main reason was FDA advice to optimize the Abdominal Fat Rating Scale (AFRS) used in the trial. According to CEO凌玉芳, this optimization involves additional validation studies, improved photo selection, and expression methods to make it easier for subjects to interpret. Notably, the FDA did not question the trial design, drug safety, or efficacy—this is essentially an approval—but the delay decision triggered panic in the market.

What is even more intriguing is the behavior of insiders. According to data from the Public Information Observation Station, insiders have been reducing holdings for three consecutive months: in June, they sold 137 shares (pre-split), in July, 117 shares, and in August, four managers sold a total of 324 shares. Insider selling often reflects true market expectations; they started to exit before the stock price declined, which undoubtedly reinforced market pessimism about the company's prospects.

Management has tried to dispel concerns.凌玉芳 emphasized that the company is negotiating licensing agreements with multiple international pharmaceutical giants, including some of the top ten global drug companies. She also described the postponement of patient enrollment as a "proactive choice" rather than a passive response, aiming to improve the success rate of registration and approval. This statement indicates the company hopes the market will reframe this event as a positive signal.

However, analysis from South China Securities Investment Consulting points out the core issue: although CBL-514, as a novel mechanism partial fat reduction drug, has promising prospects, the delay in Phase 3 trials means the earliest US approval would be in 2029. The Asian market will also need to conduct Phase 3 trials again. These time costs pose significant pressure on 康霈\*, which already has a market value exceeding USD 10 billion. Especially in the highly competitive obesity treatment sector, timing often determines market position.

The fall of the biotech king reflects the challenges new drug R&D companies face in regulatory communication and progress management. Future market focus will likely center on three aspects: whether the company can successfully complete the AFRS optimization, whether international licensing can accelerate, and whether interim data analysis meets expectations. These uncertainties will directly influence investors' judgments of 康霈\*’s future performance.