The tariff classification of BHV-1600 from China

N355252 November 18, 2025 CLA-2-98:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 9817.85.01 Javier Gonzalez Biohaven Pharmaceuticals Inc. 215 Church St. New Haven, CT 06510 RE: The tariff classification of BHV-1600 from China Dear Mr. Gonzalez: In your letter dated October 24, 2025, you requested a tariff classification ruling on BHV-1600. This ruling request was submitted by Kirti Jadeja, Global Trade Advisory, Deloitte Tax LLP. BHV-1600 is a novel bifunctional extracellular protein degrader designed to selectively bind circulating anti-1AR autoantibodies, redirecting them to the liver for ASGPR-mediated endolysosomal degradation. BHV1600 is being developed for the treatment of Dilated Cardiomyopathy (DCMs) caused by humoral autoimmune response to 1AR. In your letter, you indicated the BHV-1600 will be imported for investigational research and drug development purposes to conduct Phase 1 through Phase 3 clinical trials. The BHV-1600 will be imported as the BHV-1600 drug product and BHV-1600 Active Pharmaceutical Ingredient (API). Biohaven Pharmaceuticals, Inc. (“Biohaven”) has an approved IND from the FDA for BHV-1600 to support testing and clinical trials for drug development. The BHV-1600 drug product will be used in Phase 1 clinical trial through Phase 3 clinical trial studies to test for efficacy in treating Dilated cardiomyopathy (DCM)s caused by humoral autoimmune response to 1AR. The BHV-1600 API will be formulated into the drug product for testing or for use in toxicology studies to evaluate safety and efficacy in disease treatment in living organisms. The BHV-1600 will be imported in two different forms as follows: 1. API formulated in a solution. 2. Sterile drug product solution in glass vials. You inquired about whether the imported BHV-1600 qualifies for duty free treatment as a prototype under subheading 9817.85.01, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Prototypes to be used exclusively for development, testing, product evaluation, or quality control purposes.” You indicated that Biohaven will import the BHV-1600 for further drug development in limited non-commercial quantities in accordance with industry practice solely to conduct FDA clinical trials and toxicology studies. You further indicate that Biohaven will not incorporate BHV-1600 into other products that will be sold and any remaining BHV-1600 will be disposed of in accordance with applicable regulations. Finally, you state that BHV-1600 is not subject to any of the restrictions detailed in paragraph (c) of U.S. Note 7 to Chapter 98, HTSUS. Based on the information presented, we find that BHV-1600, imported in two different forms, qualifies for duty free treatment as a prototype under subheading 9817.85.01, HTSUS, provided that all of the conditions delineated in U.S. Note 7, Chapter 98, Subchapter XVII, Harmonized Tariff Schedule of the United States, (HTSUS) are satisfied. The applicable subheading for the subject merchandise will be 9817.85.01, HTSUS, which provides for “Prototypes to be used exclusively for development, testing, product evaluation, or quality control purposes.” The rate of duty will be free. Please note a statistical classification in chapters 1-97 for subheading 9817.85.01, HTSUS, is also required. Statistical Note 1 to Subchapter XVII of Chapter 98, HTSUS, states, in pertinent part: For statistical reporting of merchandise under subheading [ ] …9817.85.01, …: (a) Report the 8-digit number (or 10-digit number, if any) found in this subchapter in addition to the 10-digit number appearing in chapters 1-97 which would be applicable but for the provisions of this subchapter; We note that the request did not seek a determination as to the statistical classification in chapters 1-97 for subheading 9817.85.01, HTSUS; as such, this ruling does not address this issue. The tariffs and additional duties cited above are current as of this ruling’s issuance. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided at https://hts.usitc.gov/. This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov. The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact National Import Specialist Judy Lee at judy.h.lee@cbp.dhs.gov. Sincerely, (for) Deborah Marinucci Designated Official Performing the Duties of the Division Director National Commodity Specialist Division