CLA-2-98:OT:RR:NC:N3:138
Neil Flanagan
Apollo Therapeutics Ltd
3rd Floor, 22 Station Road
Cambridge CB1 2JD
United Kingdom
RE: The tariff classification of HEC88473 Drug Product (also known as APL-18881) in dosage form, from
China
Dear Mr. Flanagan:
In your letter dated July 4, 2025, you requested a tariff classification ruling. We apologize for the delay as the
information was submitted to our laboratory for analysis.
HEC88473 (also known as APL-18881) is a biological bi-specific protein targeting glucagon-like peptide-1
(GLP-1) and fibroblast growth factors 21 (FGF21). It is being developed for the treatment of non-alcoholic
steatohepatitis (NASH) and Alcohol Use Disorder (AUD). In your letter, you stated the HEC88473 drug
product will be imported in 15 mg, 30 mg and 45 mg pre-filled syringes for subcutaneous administration in
clinical trials. According to our laboratory, HEC88473 is a modified immunological product.
The applicable subheading for the HEC88473 drug product in dosage form will be 3002.15.0091,
Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Immunological products,
put up in measured doses or in forms or packings for retail sale: Other.” The general rate of duty will be free.
You also inquired about whether the imported HEC88473 drug product qualifies for duty free treatment as a
prototype under subheading 9817.85.01, HTSUS, which provides for “Prototypes to be used exclusively for
development, testing, product evaluation, or quality control purposes.” You indicated that the HEC88473
drug product will be imported solely for use in Phase 2 clinical studies. You also stated the HEC88473 drug
product will be imported in approximately 10.98 kg in limited non-commercial quantities solely for use in
clinical trials. You further indicate the imported product will not be sold and it is not subject to any
quantitative restrictions, antidumping orders, or countervailing duty orders.
Based on the information presented, we find that HEC88473 drug product, 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 HEC88473 drug product 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.
The 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 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 Frequently Asked Questions on
the Trade Remedy/IEEPA page at
https://www.cbp.gov/trade/programs-administration/trade-remedies/IEEPA-FAQ.
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 [email protected].
Sincerely,
(for)
Evan Conceicao
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division