CLA-2-29:OT:RR:NC:N3:138
Kamil Sitarz
Ryvu Therapeutics
Sternbacha Street 2
Kraków 30-394
Poland
RE: The tariff classification of RVU305 in bulk form, from China
Dear Ms. Sitarz:
In your letter dated July 23, 2025, you requested a tariff classification ruling.
RVU305 is an MTA-cooperative PRMT5 inhibitor that selectively impedes the growth of cancer cells with
MTAP deletions, while sparing normal cells. The RVU305 will be undergoing drug development in the
pre-IND stage for use in Phase 1 clinical studies. In your letter, you indicated the RVU305 will be imported
in bulk form and formulated into dosage form tablets for first-in-human, Phase I clinical studies on solid
tumors.
The applicable subheading for the RVU305 in bulk form will be 2934.99.3900, Harmonized Tariff Schedule
of the United States (HTSUS), which provides for “Nucleic acids and their salts, whether or not chemically
defined; other heterocyclic compounds: Other: Other: Aromatic or modified aromatic: Other: Other: Products
described in additional U.S. note 3 to section VI.” The general rate of duty will be 6.5 percent ad valorem.
Effective March 4, 2025, pursuant to U.S. Note 2(u) to Subchapter III, Chapter 99, all products of China and
Hong Kong as provided by heading 9903.01.24, HTSUS, other than products classifiable under headings
9903.01.21, 9903.01.22, and 9903.01.23, HTSUS, will be subject to an additional 20 percent ad valorem rate
of duty. At the time of entry, you must report the applicable Chapter 99 heading, i.e. 9903.01.24, in addition
to subheading 2934.99.3900, HTSUS, listed above.
Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must
be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the
Chapter 99 provisions covering exceptions to the reciprocal tariffs. At this time, products of China, Hong
Kong, and Macau will be assessed an additional ad valorem rate of duty of 10 percent. Your product falls
within an excepted subheading. At the time of entry, you must report the Chapter 99 heading applicable to
your product classification, i.e. 9903.01.32, in addition to subheading 2934.99.3900, HTSUS, listed above.
You also inquired about whether the imported RVU305 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 RVU305 will be imported
solely for use in Phase 1 clinical studies. You also stated the RVU305 will be imported in approximately 10
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 RVU305, 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.
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 [email protected].
Sincerely,
(for)
James Forkan
Acting Director
National Commodity Specialist Division