The tariff classification of BHV-1400 and BHV-1420 from China

N361430May 21, 2026CLA-2-98:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 9817.85.01 Javier GonzalezBiohaven Pharmaceuticals Inc.215 Church StreetNew Haven, CT 06510RE: The tariff classification of BHV-1400 and BHV-1420 from ChinaDear Mr. Gonzalez:In your letter dated April 8, 2026 , you requested a tariff classification ruling on BHV-1400 andBHV-1420. This ruling request was submitted by Kirti Jadeja, Deloitte Tax LLP.BHV-1400 is an engineered bifunctional antibody conjugate designed to selectively recognize and degradecirculating pathogenic Gd-IgA1 for the treatment of IgA nephropathy autoimmune diseases, specifically forBerger’s disease. In your letter, you indicated that the BHV-1400 will be imported for investigationalresearch and drug development purposes to conduct Phase 1 through Phase 3 clinical trials. The BHV-1400will be imported as the BHV-1400 drug product and BHV-1400 Active Pharmaceutical Ingredient (API).Biohaven Pharmaceuticals, Inc. (“Biohaven”) has an approved IND from the FDA to support the execution ofearly-stage clinical trials for drug development. The BHV-1400 drug product will be used in Phase 1 throughPhase 3 clinical trial studies to test for efficacy in treating IgA nephropathy (IGAN), and other IgAautoimmune diseases. The BHV-1400 API will be formulated into the drug product for testing or for use intoxicology studies to evaluate safety and efficacy in disease treatment in living organisms.The BHV-1400will be imported in four different forms as follows: APIin solution. Sterile drug product in vials. glassSingle use Prefilled Syringe a auto-injector device.(PFS) ssembled intoPFS without the auto-injector device.BHV-1420 is a targeted bifunctional degrader of anti-PLA2R autoantibodies that is being tested againstmultiple autoimmune diseases, specifically for the treatment of Idiopathic Membranous Nephropathy(“IMN”). In your letter, you indicated that the BHV-1420 will be imported for investigational research anddrug development purposes to conduct Phase 1 through Phase 3 clinical trials. The BHV-1420 will be imported as the BHV-1420 drug product and BHV-1420 API. Biohaven has an approved IND from the FDAto support the execution of early stage clinical trials for drug development. The BHV-1420 drug product willbe used in Phase 1 through Phase 3 clinical trial studies to test for efficacy in treating autoimmune diseases.The BHV-1420 API will be formulated into the drug product for testing or for use in toxicology studies toevaluate safety and efficacy in disease treatment in living organisms.The BHV-1420 will be imported in two different forms as follows:API in solution.Sterile drug product in glass vials.You inquired about whether the imported BHV-1400 and BHV-1420 qualifies for duty free treatment asprototypes under subheading 9817.85.01, Harmonized Tariff Schedule of the United States (HTSUS), whichprovides for “Prototypes to be used exclusively for development, testing, product evaluation, or qualitycontrol purposes.” You indicated that Biohaven will import the BHV-1400 and BHV-1420 for further drugdevelopment in limited non-commercial quantities in accordance with industry practice solely to conductFDA clinical trials and toxicology studies. You further indicate that Biohaven will not incorporate BHV-1400and BHV-1420 into other products that will be sold and any remaining BHV-1400 and BHV-1420 will bedisposed of in accordance with applicable regulations. Finally, you state that BHV-1400 and BHV-1420 arenot 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-1400 and BHV-1420, imported in various forms,qualifies for duty free treatment as prototypes under subheading 9817.85.01, HTSUS, provided that all of theconditions delineated in U.S. Note 7, Chapter 98, Subchapter XVII, HTSUS are satisfied.The applicable subheading for the BHV-1400 and BHV-1420 will be 9817.85.01, HTSUS, which providesfor “Prototypes to be used exclusively for development, testing, product evaluation, or quality controlpurposes.” The general 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-digitnumber 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 forsubheading 9817.85.01, HTSUS; as such, this ruling does not address this issue. You also submitted a rulingrequest for BHV-1450 which will be issued separately under ruling N360524.The duties cited above are current as of this ruling’s issuance. Duty rates are provided for your convenienceand are subject to change. The text of the most recent HTSUS and the accompanying duty rates are providedat https://hts.usitc.gov/.This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or othercharges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and otherduties as provided for in Subchapter III to Chapter 99, HTSUS.Thus, for example, in addition to the classification stated above, the merchandise covered by this ruling may also need to be reported with eitherthe Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisionscovering exceptions to such tariffs. For further information to assist with the importation process, please refer to the frequently updated CargoSystems Messaging Service (CSMS) messages at https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and the Trade Remedies page at https://www.cbp.gov/trade/programs-administration/trade-remedies.The holding set forth above applies only to the specific factual situation and merchandise description asidentified 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 theinformation furnished in the ruling letter, whether directly, by reference, or by implication, is accurate andcomplete in every material respect. In the event that the facts are modified in any way, or if the goods do notconform to these facts at time of importation, you should bring this to the attention of U.S. Customs andBorder 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 periodicverification by CBP.This ruling is being issued under the provisions of Part 177 of the Customs and Border ProtectionRegulations (19 C.F.R. 177).A copy of the ruling or the control number indicated above should be provided with the entry documentsfiled at the time this merchandise is imported. If you have any questions regarding the ruling, please contactNational Import Specialist Judy Lee at judy.h.lee@cbp.dhs.gov. Sincerely, (for)James P. ForkanDirectorNational Commodity Specialist Division