Second Amendment to License Agreement by and between Athenex, Inc. and PharmaEssentia Corp., effective as of November 27, 2018

Exhibit 10.46

Portions of this exhibit marked [*] are requested to be treated confidentially.

SECOND AMENDMENT TO LICENSE AGREEMENT

This SECOND AMENDMENT TO LICENSE AGREEMENT (this “Second Amendment”) is made and entered into as of this 27th day of November, 2018 (“Effective Date”) by and between Athenex, Inc., formerly known as Kinex Pharmaceuticals, Inc., a corporation organized and existing under the laws of the state of Delaware, USA, with a principal place of business at 1001 Main Street, Suite 600, Buffalo, New York 14203 (“Athenex” or “Kinex”), and PharmaEssentia Corp., a publicly traded company organized and existing under the laws of Taiwan with a principal place of business at 13F., No. 3 YuanQu Street, Nankang District, Taipei 115, Taiwan (“PharmaEssentia”).

WITNESSETH:

WHEREAS, Athenex and PharmaEssentia entered into a License Agreement on December 16, 2013 for the license by Athenex to PharmaEssentia of rights in Oraxol and Oratecan, which agreement was subsequently amended by a First Amendment to License Agreement on December 23, 2016 (collectively, the “License”);

WHEREAS, Athenex and PharmaEssentia wish to amend the terms of the License to add the rights to Athenex’s Oradoxel and to make other amendments;

NOW, THEREFORE,

“1.42 ‘Licensed Product(s)’ means Oraxol, Oratecan and Oradoxel for use in the Territory.”

“1.46.5 ‘Oradoxel’ means any oral dosage, chemotherapy drug that contains the Compound and Docetaxel as active pharmaceutical ingredients.”

“3.2(a) General.  PharmaEssentia shall be responsible for and shall itself, or through its Affiliates or Third Parties, conduct Development and Commercialization in the Territory in the Field during the term of this Agreement.  Within 60 days after the Effective Date, PharmaEssentia shall prepare a draft plan and budget (in English) for Development and Commercialization in each of the countries within the Territory and submit such draft plan to the Steering Committee (as defined in Section 3.4) which will agree on and oversee the plan for Development and Commercialization (the “Development Plan”) during the term of this Agreement.  If PharmaEssentia fails to (i) file an IND with the Taiwan Regulatory Authority within six months after Kinex provides it with the IND that Kinex has filed with the United States Regulatory Authority, (ii) assuming that a 505b2 strategy is allowed by Taiwan FDA, enrollment of at least forty (40) patients for the Oraxol program within eighteen (18) months after IND is allowed by the Taiwan FDA, (iii) assuming that a 505b2 strategy is allowed,

enrollment of at least forty (40) patients for the Oratecan program within 18 months after the IND for Oratecan is allowed by the Taiwan FDA, (iv) file an IND application to Drug Administration Of Vietnam for the Oraxol program by December 31, 2019, and (v) file an application for a Free Sale Certificate within three (3) months after the approval of an NDA for each Licensed Product, all rights and licenses under this Agreement shall immediately terminate, provided, however, Kinex shall grant a six month extension on any of the foregoing timelines at the reasonable written request of PharmaEssentia prior to any termination of this Agreement.

“(i)conduct all Clinical Studies in the Territory for Oraxol, Oratecan and Oradoxel in support of the clinical strategy under the Development Plan; and

(ii)participate in the Phase III Studies for Oraxol, Oratecan and Oradoxel in such a manner in conjunction with Kinex which will support PharmaEssentia’s application for a Regulatory Approval of Licensed Product in each of the countries within the Territory.”

“(k) Supply of Licensed Product.  Kinex shall supply PharmaEssentia free of charge, in accordance with regulatory requirements and as requested in writing by PharmaEssentia, the Licensed Products that are sufficient for the Clinical Studies (up to 80 patients) in the Territory, except for Oradoxel.  For Oradoxel, Kinex shall supply PharmaEssentia, in accordance with regulatory requirements and as requested in writing by PharmaEssentia, Oradoxel sufficient for Clinical Trials in the Territory and PharmaEssentia shall be responsible to Kinex for the reasonable cost and expense of such supply.”

[*]Confidential treatment requested; certain information omitted and filed separately with the SEC.

IN WITNESS WHEREOF, Athenex and PharmaEssentia have executed this First Amendment as of the date first set forth above.

[*]Confidential treatment requested; certain information omitted and filed separately with the SEC.