Behind Shengnuo Bio's FDA Import Ban: Heightened Scrutiny on GLP-1 API Suppliers

Source: Jian Shi Ju

In the first half of 2026, a Chinese pharmaceutical company generated revenue in the U.S. market that exceeded its total annual revenue for 2025, only to be abruptly placed on the FDA’s ban list.

September 22,Sheng Nuo BiotechAnnouncement,Wholly-ownedChildSirnaomics has been placed on the U.S. FDA’s Import Alert No. 66-40 list.Sirnaomics will completely halt all sales and shipments of peptide active pharmaceutical ingredients (APIs) to the U.S. market until the FDA lifts the relevant warning.

On the day of the announcement, Cheng Du Sheng Nuo Biotec Co., Ltd.’s stock price fell 18.61%, closing at RMB 19.99 per share and hitting a new 52-week low during intraday trading; on the 23rd, the company’s shares continued to decline by 1.2%.

Shengnuo Biotech is an active pharmaceutical ingredient (API) CXO company, with its most scrutinized business segment being GLP-1 peptide APIs, including semaglutide API and tirzepatide API, the latter of which was filed with the U.S. Food and Drug Administration (FDA) in May this year. There had been speculation that Shengnuo Biotech was one of Eli Lilly’s suppliers.A small-cap company, partnering with the global top two best-selling drugs, has drawn significant market attention.

Given that none of Sirnaomics’ peptide active pharmaceutical ingredients (APIs) can currently be sold to the United States, it is no surprise that the market reaction has been so severe. Moreover, Sheng Nuo Biotec’s U.S. business is precisely in a phase of accelerated volume growth: in 2025, its revenue from the U.S. market amounted to RMB 153 million, and in the first half of 2026, this figure had already reached RMB 167 million, accounting for 32.83% of its total revenue.A single ban has disrupted Sheng Nuo Biotec’s accelerating U.S. business operations. In its announcement, Sheng Nuo Biotec also stated that this incident will impact its business operations.

Why Did the Rectification Response Fail to Prevent the Ban?

The FDA took decisive action this time.

The incident originated on August 27, when the FDA issued an Inspectional Observation Report (Form FDA 483) to Cheng Du Sheng Nuo Biotec Co., Ltd. According to the company’s announcement,Form 483 lists eight observations,It primarily focuses on the same product portfolio and the same production and packaging processes, involving the identification of critical quality attributes, contamination control capabilities, detection and result acceptance capabilities, as well as aspects related to the quality management system.

Form 483, which lists the potential violations identified by the FDA during an on-site inspection of a company,Major Chinese pharmaceutical companies that export products to the United States, such as WuXi Biologics,Bio-Thera Solutions、Junshi Biosciencesand others have been obtained。As required, the company must submit a written response within 15 business days, analyze the root cause of the issue, and provide a corrective action plan to have the opportunity to gain FDA approval.

The issue is that, on September 17, Sheng Nuo BiotecTo the FDASubmittedRectification Response, butJust two days laterSeptember 19, the FDAXuanClothWillSheng NuoBiologyListed in the Import Ban List No. 66-40。

This ban is not directed at any specific peptide product, but rather covers all products from the manufacturing facility. This means that,This regulatory scrutiny may have extended from whether a specific batch of products is compliant to this factory'sGMPSystem，The FDA considers that Cheng Du Sheng Nuo Biotec Co., Ltd. is unable to consistently ensure product quality.

This may involve the company’s entire quality control chain: Has the company clearly identified which indicators determine product quality? During production, can cross-contamination and other contamination risks be effectively prevented? After anomalies are detected during testing, how are they investigated, confirmed, and handled? Can the quality department independently identify issues and drive corrective actions? The FDA is certain to raise questions on these matters.

In May this year, the two active pharmaceutical ingredients (APIs) of tirzepatide and terlipressin acetate from Shengnuo Biotech were successively approved by the FDA for DMF filing and entered into an activated status. This means that companies can purchase these two APIs for use in manufacturing drug products and submit applications to the FDA.Shengnuo Biotech previously had 11 active pharmaceutical ingredients (APIs) filed with the U.S. Drug Master File (DMF) and in activated status,including bivalirudin, eptifibatide, liraglutide, semaglutide, etc.

Generally, filing a Drug Master File (DMF) does not trigger an FDA on-site inspection. However, if a company procures active pharmaceutical ingredients (APIs) from Cheng Du Sheng Nuo Biotec Co., Ltd. and submits a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) for the resulting drug product to the FDA, the agency will conduct an on-site inspection. This product has been clearly identified as a peptide API, primarily corresponding to GLP-1 APIs such as semaglutide and tirzepatide.

In other words, Cheng Du Sheng Nuo Biotec Co.,ltd may be on the verge of signing a major contract.Moment, suddenly flagged in redBrand。

Rapid Expansion of GLP-1 Drug Demand Creates a Windfall for Upstream API Manufacturers. In 2025, the combined sales of the two core products, semaglutide and tirzepatide, exceeded $72 billion.Guosen SecuritiesThe CXO industry report released in July 2026 predicts that the global market size for peptide drugs will reach $160.3 billion by 2030.

WhoBeing able to catch this wave of opportunity,As forWill Take Off Vertically，Chengdu Sheng Nuo Biotec may have been all set for takeoff, only to be hit by an unexpected ban.

The Higher the Overseas Revenue, the Harder It Is to Bypass FDA Approval

In accordance with relevant FDA regulations, import alerts for listed facilities may be lifted upon verification of corrective actions or following a successful FDA re-inspection.

How long does this process typically take? There is significant variation among publicly available cases. Indian active pharmaceutical ingredient (API) manufacturer Aarti Drugs underwent an FDA inspection in September 2024 and was removed from the Import Alert 66-40 list in February 2025.From examination to recovery, approximately 5 months;Global Calcium was added to the 66-40 list in December 2024 and remained restricted until August 2026, a period spanning nearly 20 months.

For a company whose U.S. revenue already accounts for more than 30%, each additional quarter of the ban will directly impact its financial performance. Moreover, as competitors strive to gain ground, even a slight lag could result in missed market opportunities.

The first half of 2026,Hybio PharmaceuticalRevenue from active pharmaceutical ingredient (API) business reached RMB 546 million, representing a year-on-year increase of 217.67%.AsymchemDisclosure: The total production capacity for solid-phase peptide synthesis is expected to increase to 69,000 liters by the end of 2026. Nuotai Bio’s fourth-generation ton-scale peptide production workshop has also commenced operations. Peptide suppliers are vying for greater market share; for Shengnuo Bio, an initial delay could lead to a cascade of setbacks.

NearPeriod, the US market is strengthening its scrutiny of API suppliers, particularly for GLP-1 APIs.

The FDA, through on-site inspections, remote assessments, and other methods, addresses issues within the U.S. supply chain of48 GLP-1 active pharmaceutical ingredient (API) manufacturing sites were assessed, with 21% found to be non-compliant.Reasons include data reflecting non-compliance with Good Manufacturing Practice (GMP) regulations, or failure to respond in a timely manner to requests for record retrieval.

The impact of stricter regulatory oversight extends beyond just Cheng Du Sheng Nuo Biotec Co., Ltd. In May this year, the FDA issued toHarbin Jixianglong BiotechnologyIssued a warning letter, pointing out that the enterpriseRepurchased semaglutide API was repackaged, relabeled, and marked as self-produced.The external sourcing originates from manufacturing sites not included in the FDA’s Green List (66–80). The FDA also cited deficiencies in process validation, cleaning validation, and other areas.

Special Statement: The above content represents only the views or positions of the author and does not reflect the views or positions of Sina Finance Headlines. If you need to contact Sina Finance Headlines regarding the content, copyright, or other issues, please do so within 30 days of the publication of the above content.