SKADDEN, ARPS, SLATE, MEAGHER & FLOM | ||||
DIRECT DIAL +852 3740 4863 DIRECT FAX +852 3910 4863 EMAIL ADDRESS JULIE.GAO@SKADDEN.COM
PARTNERS CHRISTOPHER W. BETTS GEOFFREY CHAN * ANDREW L. FOSTER * CHI T. STEVE KWOK * EDWARD H.P. LAM ◆* HAIPING LI * RORY MCALPINE ◆ JONATHAN B. STONE * PALOMA P. WANG ◆ (ALSO ADMITTED IN ENGLAND & WALES) * (ALSO ADMITTED IN NEW YORK)
REGISTERED FOREIGN LAWYER Z. JULIE GAO (CALIFORNIA) |
世達國際律師事務所
42/F, EDINBURGH TOWER, THE LANDMARK 15 QUEENS ROAD CENTRAL, HONG KONG
TEL: (852) 3740-4700 FAX: (852) 3740-4727 www.skadden.com |
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October 4, 2019 |
Confidential
Ms. Christine Torney
Mr. Kevin Vaughn
Mr. Jeffrey Gabor
Ms. Christine Westbrook
Division of Corporation Finance
Office of Healthcare & Insurance
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re: | I-Mab (CIK No. 0001778016) |
Response to the Staffs Comments on |
Amendment No.1 to Draft Registration Statement on Form F-1 |
Confidentially Submitted on September 5, 2019 |
Dear Ms. Torney, Mr. Vaughn, Mr. Gabor, and Ms. Westbrook:
On behalf of our client, I-Mab, a foreign private issuer organized under the laws of the Cayman Islands (the Company), we submit to the staff (the Staff) of the Securities and Exchange Commission (the Commission) this letter setting forth the Companys responses to the comments contained in the Staffs letter dated September 19, 2019 on the Companys amendment No.1 to draft registration statement on Form F-1 confidentially submitted on September 5, 2019 (the Draft Registration Statement).
Concurrently with the submission of this letter, the Company is submitting its revised draft registration statement on Form F-1 (the Revised Draft Registration Statement) and certain exhibits via EDGAR to the Commission for confidential review.
Securities and Exchange Commission
October 4, 2019
Page 2
To facilitate the Staffs review, we have separately delivered to the Staff today five courtesy copies of the Revised Draft Registration Statement, marked to show changes to the Draft Registration Statement, and two copies of the submitted exhibits.
The Staffs comments are repeated below in bold and are followed by the Companys responses. We have included page references in the Revised Draft Registration Statement where the language addressing a particular comment appears. Capitalized terms used but not otherwise defined herein have the meanings set forth in the Revised Draft Registration Statement.
Amendment No. 1 to Draft Registration Statement on Form F-1 submitted September 5, 2019
Prospectus Summary
Overview, page 1
1. | We note your response to prior comment 1 and your continued references to potentially first-in-class or best-in-class product candidates. We continue to object to these terms as implying your product candidates are likely to be approved and/or that you will be successful in achieving a given market share, which are inappropriate for you to imply given the uncertainty in the development of biologics. As illustrative examples, we will not object to disclosure stating that TJ107 is the first long-acting recombinant human interleukin-7, Enoblituzumab is the most advanced clinical stage humanized antibody targeting T cell checkpoint regulator B7-H3, and TJX7 is the first humanized neutralizing antibody targeting CXCL13 chemokine. |
The Company respectfully acknowledges the Staffs comment and advises the Staff that all references to first-in-class or best-in-class have been removed throughout the Revised Draft Registration Statement.
Securities and Exchange Commission
October 4, 2019
Page 3
Our Global Strategic Collaborations, page 5
2. | We note your response to comment 15. Please expand your Summary disclosure to disclose that you are the sublicensee under your agreement with Ferring International Center SA related to TJ301, as discussed on page 186. |
The Company respectfully acknowledges the Staffs comment and advises the Staff that it has revised the disclosure on pages 4 and 138 of the Revised Draft Registration Statement.
Business
Collaboration Agreement with MacroGenics (enoblituzumab), page 186
3. | We note your response to prior comment 16 and your revised disclosure indicating that unless prohibited by applicable laws and regulations, you will co-own all clinical data and, to the extent joint ownership is not legally permitted, MacroGenics will be the sole and exclusive owners of such clinical data. Please revise to explain your reference to applicable law or regulation that would preclude you from joint ownership and, to the extent known and applicable, disclose whether you currently qualify for joint ownership. |
The Company respectfully acknowledges the Staffs comment and advises the Staff that it has revised the disclosure on page 185 of the Revised Draft Registration Statement.
Taxation
PRC Taxation, page 274
4. | We note your response to comment 19, which we reissue in part. Please revise your disclosure to clearly state that the disclosure in this section is the opinion of named counsel. |
The Company respectfully acknowledges the Staffs comment and advises the Staff that it has revised the disclosure on page 274 of the Revised Draft Registration Statement.
Securities and Exchange Commission
October 4, 2019
Page 4
Exhibits
5. | It appears your are attempting to redact information pursuant to Item 601(b)(10)(iv) of Regulation S-K from Exhibits 10.14, 10.15, 10.16, 10.18, 10.19, 10.20, and 10.21. Please revise your Exhibit Index as appropriate and refile these exhibits to include on the first page of each redacted exhibit the legend required by Item 601(b)(10)(iv) of Regulation S- K or refile the complete agreement. We note your reference to Rule 406 with respect to Exhibits 10.13 and 10.17. Please tell us whether you plan to submit an application for confidential treatment pursuant to Rule 406 or advise. |
The Company respectfully acknowledges the Staffs comment and advises the Staff that it has refiled the complete agreements for Exhibits 10.14, 10.15, 10.16, 10.18, 10.19, 10.20, and 10.21 and revised the rule reference with respect to Exhibits 10.13 and 10.17 to Item 601(b)(10)(iv) of Regulation S-K.
* * *
Securities and Exchange Commission
October 4, 2019
Page 5
If you have any questions regarding the Revised Draft Registration Statement, please contact the undersigned by phone at +852-3740-4863 or by e-mail at julie.gao@skadden.com or Jane Kong, the partner at PricewaterhouseCoopers Zhong Tian LLP, by telephone at +86-21-2323-2648 or by email at Jane.kong@cn.pwc.com. PricewaterhouseCoopers Zhong Tian LLP is the independent registered public accounting firm of the Company.
Very truly yours, |
/s/ Z. Julie Gao |
Z. Julie Gao |
Enclosures
cc: | Jingwu Zhang Zang, Chairman of the Board of Directors, I-Mab |
Jielun Zhu, Director and Chief Financial Officer, I-Mab
Haiping Li, Esq., Partner, Skadden, Arps, Slate, Meagher & Flom LLP
Jane Kong, Partner, PricewaterhouseCoopers Zhong Tian LLP
Li He, Esq., Partner, Davis Polk & Wardwell LLP