After its subsidiary Sheng Nuo Pharmaceutical underwent an on-site FDA inspection, peptide CDMO company Chengdu Sheng Nuo Biotec Co.,Ltd. (688117) received a Form 483 observation list and was subsequently placed on the import ban list. The US market has already become an important source of revenue for the company, and this regulatory event will bring significant uncertainty to its operations.

FDA on-site inspection exposes multiple defects in the quality system

After completing the FDA on-site inspection, Sheng Nuo Pharmaceutical received a Form FDA 483 observation list with a total of eight defects. The problems were concentrated in several key aspects of production quality management, including identification of critical quality attributes, contamination control, acceptance of test results, and quality system governance, covering the entire production and packaging process for the same group of products. The company was then added to the FDA import ban list, meaning exports of its products to the United States will be restricted. As of now, the company has not received an FDA warning letter or a final official disposition conclusion, but the ban has already objectively created a binding constraint. In the peptide CDMO business, overseas clients have stringent requirements for good manufacturing practices. The results of FDA on-site inspections directly determine whether a company can secure overseas orders. The listing of multiple quality defects reflects shortcomings in the company's quality control system. If effective rectification cannot be completed later, not only will existing export business be blocked, but the company's brand reputation among global pharmaceutical clients will also be damaged, affecting future expansion of overseas orders.

Rapidly rising share of US revenue means performance may take a hit

Chengdu Sheng Nuo Biotec Co.,Ltd. (688117) is mainly engaged in peptide drug CDMO and the sale of peptide APIs and formulations. In recent years, its performance has grown rapidly, and the share of its US market business has climbed quickly. In 2025, sales revenue from the United States was 153 million yuan, accounting for 20.19% of total revenue; in the first half of 2026, US revenue reached 167 million yuan, with its share surging to 32.83%. Overseas business, especially the US market, has become an important pillar of the company's performance. The import ban directly hits exports of products to the United States. If the rectification cycle is prolonged, the delivery of related orders and revenue recognition will both be affected, directly weighing on revenue and profit. There are two major things to watch going forward: first, the progress of the company's rectification and whether it can eliminate the various defects raised by the FDA as soon as possible and lift the import restrictions; second, whether confidence among overseas clients wavers and whether order losses occur. Although the company's performance has been improving in the short term, regulatory compliance risks have already emerged, and the degree of disruption to its US business will become a key variable affecting the company's future performance.