The tariff classification of BHV-1500, BHV-1510, and BHV-1530 from China

N360154 April 24, 2026 CLA-2-98:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 9817.85.01 Javier Gonzalez Biohaven Pharmaceuticals Inc. 215 Church Street New Haven, CT 06510 RE: The tariff classification of BHV-1500, BHV-1510, and BHV-1530 from China Dear Mr. Gonzalez: In your letter dated March 30, 2026, you requested a tariff classification ruling on BHV-1500, BHV-1510, and BHV-1530. This ruling request was submitted by Kirti Jadeja, Deloitte Tax LLP. BHV-1500 consists of Brentuximab, a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody (mAb) directed against a cluster of differentiation (CD) 30 conjugated to the monomethyl auristatin E (MMAE), a microtubule-disrupting agent. The product attacks cells that contain CD30 and gets into the tumor cells to stop its ability to grow and divide, resulting in death of the cancer cells. In your letter, you indicated the BHV-1500 will be imported as the BHV-1500 Active Pharmaceutical Ingredient (API) and as the BHV-1500 drug product for investigational research and drug development purposes to conduct Phase 1 through Phase 3 clinical trials. The BHV-1500 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-1500 drug product will be used in Phase 1 through Phase 3 clinical trial studies to test for efficacy in treating lymphoma and other solid tumors. BHV-1510 consists of a recombinant humanized immunoglobulin G1 (IgG1) anti-trophoblast cell surface antigen 2 (Trop-2) monoclonal antibody (BH-0006587), a cleavable linker-payload (BH-0006588) which includes a deoxyribonucleic acid (DNA) topoisomerase I inhibitor (TopoIx) payload (BHC-0080269). BHV-1510 binds to the Trop-2 receptor on cancer cell surfaces, killing tumor cancer cells. In your letter, you indicated the BHV-1510 will be imported as the BHV-1510 API and BHV-1510 drug product for investigational research and drug development purposes to conduct Phase 1 through Phase 3 clinical trials. The BHV-1510 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-1510 drug product will be used in Phase 1 through Phase 3 clinical trial studies to test for efficacy in treating tumors. BHV-1530 is an ADC of a specific anti-FGFR3 human monoclonal antibody (mAb), BHC-0080276, conjugated through site-specific conjugation to a novel topoisomerase I (Topo I) inhibitor, free payload (TopoIx) (BHC-70080269). BHV-1530 is designed to target tumors with FGFR3 alterations, overexpression, or fusions, and is anticipated to be potentially effective against tumors exhibiting these FGFR3-related abnormalities. In your letter, you indicated the BHV-1530 will be imported as the BHV-1530 API and BHV-1530 drug product for investigational research and drug development purposes to conduct Phase 1 clinical trials. In a follow-up email to this office, you stated that if Phase 1 clinical trials will be successful, it will move to Phase 2 and 3 clinical trials. The BHV-1530 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-1530 drug product will be used in Phase 1 through Phase 3 clinical trial studies to test for efficacy in treating solid tumors. The BHV-1500, BHV-1510 and BHV-1530 has IND’s from the FDA to support the execution of early stage clinical trials for drug development and to support the commencement of clinical trials. They will be imported in two different forms as follows: 1. APIs in frozen liquid form. 2. Sterile drug product in single dose vials (BHV-1500) and in 100 mg/5 mL glass vials (BHV-1510 and BHV-1530). You inquired about whether the imported BHV-1500, BHV-1510, and BHV-1530 qualifies for duty free treatment as prototypes in 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-1500, BHV-1510, and BHV-1530 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-1500, BHV-1510, and BHV-1530 into other products that will be sold and any remaining BHV-1500, BHV-1510, and BHV-1530 will be disposed of in accordance with applicable regulations. Finally, you state that BHV-1500, BHV-1510, and BHV-1530 are 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-1500, BHV-1510, and BHV-1530, imported in two different forms, qualifies for duty free treatment as prototypes in 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 BHV-1500, BHV-1510, and BHV-1530 will be 9817.85.01, HTSUS, which provides for “Prototypes to be used exclusively for development, testing, product evaluation, or quality control purposes.” 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-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. This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or other charges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and other duties 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 either the Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisions covering exceptions to such tariffs. For further information to assist with the importation process, please refer to the frequently updated Cargo Systems 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 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) James P. Forkan Director National Commodity Specialist Division