# EDGAR Filing Document

**Accession Number:** 0001835268
**File Stem:** 0001628280-25-034551
**Filing Date:** 2025-7
**Character Count:** 18452
**Document Hash:** 2add4f452038c9589193840c0118798a
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001628280-25-034551.hdr.sgml**: 20250709

**ACCESSION NUMBER**: 0001628280-25-034551

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20250709

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250709

**DATE AS OF CHANGE**: 20250709

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Connect Biopharma Holdings Ltd
- **CENTRAL INDEX KEY:** 0001835268
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** E9
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-40212
- **FILM NUMBER:** 251112396

**BUSINESS ADDRESS:**
- **STREET 1:** 3580 CARMEL MOUNTAIN ROAD, SUITE 200
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92130
- **BUSINESS PHONE:** 858-727-1040

**MAIL ADDRESS:**
- **STREET 1:** 3580 CARMEL MOUNTAIN ROAD, SUITE 200
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92130

?xml version='1.0' encoding='ASCII'? cntb-20250709

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**WASHINGTON, D.C. 20549**

________________________________________

**FORM 8-K**

________________________________________

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** July 9, 2025

________________________________________

**Connect Biopharma Holdings Limited**

**(Exact name of Registrant as Specified in Its Charter)**

________________________________________

---

| | | |
|:---|:---|:---|
| **Cayman Islands** | **001-40212** | **Not Applicable** |
| (State or Other Jurisdiction <br>of Incorporation) | (Commission File Number) | (IRS Employer <br>Identification No.) |
| | **3580 Carmel Mountain Road, Suite 200** | |
| | **San Diego, California** | **92130** |
| | (Address of Principal Executive Offices) | (Zip Code) |

---

**Registrant's Telephone Number, Including Area Code: (858) 727-1040**

________________________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

□ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

□ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

□ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

□ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

**Securities registered pursuant to Section 12(b) of the Act:**

---

| | | |
|:---|:---|:---|
| **Title of each class** | **Trading <br>Symbol(s)** | **Name of each exchange on which registered** |
| American Depositary Shares, each representing one Ordinary Share, par value $0.000174 per Share | CNTB | The Nasdaq Global Market |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. □

------

**Item 7.01 Regulation FD Disclosure.**

On July 9, 2025, Connect Biopharma Holdings Limited (the "Company") issued a press release announcing that the Company's collaborator and exclusive licensee in China, Simcere Pharmaceutical Co., Ltd. ("Simcere"), has submitted its New Drug Application ("NDA") for rademikibart to the National Medical Products Administration of China ("NMPA") for the treatment of atopic dermatitis ("AD") in adults and adolescents. A copy of the press release is furnished herewith as Exhibit 99.1 and is incorporated into this Item 7.01 by reference.

The information in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

**Item 8.01 Other Events.**

On July 9, 2025, the Company announced that Simcere has submitted its NDA for rademikibart to the NMPA for the treatment of AD in adults and adolescents.

**Forward-Looking Statements**

This disclosure, including the press release furnished herewith as Exhibit 99.1, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "expect," "anticipate," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on the Company's expectations and assumptions as of the date of this Current Report on Form 8-K. Forward-looking statements contained herein include, but are not limited to, statements regarding the Company's strategy and plans, the potential clinical effects, benefits, safety and efficacy of rademikibart, the timing, nature and significance of enrollment and data from the Company's trials evaluating rademikibart, the timing of any further releases of data or of any presentations or investor conference calls, the Company's plans and expectations for its asthma and COPD program, anticipated patient populations or market opportunities for the Company's prospective products, if approved, whether the NMPA approves Simcere's NDA and the timing of any such approval, whether the Company becomes eligible for any additional milestone or royalty payments under its agreement with Simcere, and risks and uncertainties associated with drug development and commercialization. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials or in data readouts; the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; difficulties in collaborating with other companies; successful development and/or commercialization of alternative product candidates by the Company's competitors; changes in expected or existing competition; delays in or disruptions to the Company's business or clinical trials due to geopolitical changes or other external factors; and unexpected litigation or other disputes. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements herein are discussed in the Company's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein, including in our annual report on Form 10-K for the year ended December 31, 2024, and any subsequent filings with the SEC. Except as required by law, the Company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

**Item 9.01 Financial Statements and Exhibits.**

**(d) Exhibits**

---

| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | <u>[Press Release of the Company, dated](exhibit991-pressrelease.htm)[July 9](exhibit991-pressrelease.htm)[, 2025](exhibit991-pressrelease.htm)</u> |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

------

**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | | |
|:---|:---|:---|:---|
| | | | **CONNECT BIOPHARMA HOLDINGS LIMITED** |
| Date: | July 9, 2025 | By: | /s/ David Szekeres |
|  |  | Name: | David Szekeres |
|  |  | Title: | President |

---

## Exhibit 99.1

**Exhibit 99.1**

**Connect Biopharma's Exclusive Licensee in China, Simcere Pharmaceutical, Announced Submission of its New Drug Application for Rademikibart for the Treatment of Atopic Dermatitis in China**

SAN DIEGO July 9, 2025, (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) ("Connect Biopharma", "Connect", or the "Company"), a clinical-stage biopharmaceutical company focused on transforming care for the treatment of inflammatory diseases, today announced that the Company's collaborator and exclusive licensee in China, Simcere Pharmaceutical Co., Ltd. ("Simcere"), has submitted its New Drug Application for rademikibart to the National Medical Products Administration of China ("NMPA") for the treatment of atopic dermatitis ("AD") in adults and adolescents.

"Simcere continues to make strong progress in advancing rademikibart in China, our potentially best in class next generation IL-4Rα antibody," said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. "Atopic dermatitis remains a large and growing market in China, and rademikibart has the potential to significantly improve the condition for millions of patients. Together, we remain committed to advancing rademikibart for the treatment of a range of inflammatory diseases including AD, asthma, and chronic obstructive pulmonary disease."

In 2023, Connect and Simcere entered into an exclusive license and collaboration agreement for rademikibart in China. Under the agreement, Simcere was granted exclusive rights to develop, manufacture, and commercialize rademikibart for all indications in Greater China, including mainland China, Hong Kong, Macau, and Taiwan, while Connect retains rights in all other markets.

As part of the agreement, Connect is eligible to receive milestone payments up to an aggregate remaining amount of approximately $110 million upon the achievement of certain development, regulatory and commercial milestones. Connect is also eligible to receive royalties at tiered percentage rates up to low double-digit percentages on net sales in Greater China. The AD market in China represents considerable opportunity, with an estimated 70 million patients with AD.

**About Rademikibart**

Rademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα), a common subunit of interleukin-4 receptor (IL-4) and interleukin-13 receptor (IL-13). By binding with IL-4Rα, rademikibart can block the functions of IL-4 and IL-13 effectively, thereby blocking the T helper 2 (Th2) inflammatory pathway, thus achieving the goal of treating Th2 related inflammatory diseases such as atopic dermatitis and asthma.

**About Simcere**

Simcere Pharmaceutical Co., Ltd. is an innovation and R&D-driven pharmaceutical company and focuses on the therapeutic areas including neuroscience, anti-oncology, autoimmune and anti-infection. The company develops innovative therapies in disease areas that may have significant clinical needs in the future, aiming to achieve the mission of "for patients, for life". Driven by its in-house R&D efforts and synergistic innovation, Simcere has established strategic cooperation partnerships with many innovative companies and research institutes.

------

**About Connect Biopharma** 

Connect Biopharma is a global, clinical-stage biopharmaceutical company dedicated to developing innovative therapies and transforming care for the treatment of inflammatory diseases. The Company's lead product candidate, rademikibart (formerly known as CBP-201), is an antibody designed to target IL-4Rα and has demonstrated activity in both atopic dermatitis and asthma. The Company is currently conducting global studies of rademikibart for the treatment of acute exacerbations of asthma and COPD, areas with significant unmet need.

For more information visit www.connectbiopharm.com.

**Forward-Looking Statements**

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended (the "Act"). Forward-looking statements are statements that are not of historical fact and include, without limitation, statements regarding future events, our future financial condition, results of operations, business strategy and plans, prospective products (as well as their potential to achieve a differentiated, competitive, or favorable benefit or profile or trend, including on safety, tolerability, improvement, maintenance, clinical response, dosing, efficacy and/or convenience), planned or expected product approval applications or approvals, anticipated milestones, expected data readouts and enrollments, research and development plans and costs, potential future partnerships, expectations about existing partnerships, timing and likelihood of success, objectives of management for future operations, future results of anticipated product development efforts, adequacy of existing cash and potential partnership funding to fund operations and capital expenditure requirements, anticipated patient populations or market opportunities for our prospective products, if approved, as well as statements regarding industry trends. These statements are based on management's current expectations of future events only as of the date of this press release and are inherently subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among other things: the ability of our clinical trials to demonstrate safety and efficacy of our product candidates and other positive results; whether we will need expanded or additional trials in order to obtain regulatory approval for our product candidates; our ability to obtain and maintain regulatory approval of our product candidates; existing regulations and regulatory developments in the U.S., the PRC, Europe and other jurisdictions; the ability of our current cash and investments position to support planned operations; our plans and ability to obtain, maintain, protect and enforce our intellectual property rights and our proprietary technologies, including extensions of existing patent terms where available; our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials; and the degree of market acceptance of our product candidates, if approved, by physicians, patients, healthcare payors and others in the medical community.

Words such as "aim," "anticipate," "believe," "could," "expect," "feel," "goal," "intend," "look forward to," "may," "optimistic," "plan," "potential," "promising," "will," and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. The inclusion of forward-looking statements should not be regarded as a representation by Connect Biopharma that any of its expectations, projections or plans will be achieved. Actual results may differ materially due to the risks and

------

uncertainties inherent in our business and other risks described in our filings with the U.S. Securities and Exchange Commission (the "SEC"). Further information regarding these and other risks is included under the heading "Risk Factors" in our annual and periodic reports filed with the SEC. These forward-looking statements should not be taken as forecasts or promises nor should they be taken as implying any indication, assurance or guarantee that the assumptions on which such forward-looking statements have been made are correct or exhaustive or, in the case of the assumptions, fully stated in this presentation. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You are cautioned not to place undue reliance on the scientific data presented or any forward-looking statements, which speak only as of the date of such presentation(s) or such statements. Except as required by law, Connect Biopharma undertakes no obligation to publicly update any forward-looking statements, whether because of new information, future events or otherwise. Connect Biopharma claims the protection of the safe harbor for forward-looking statements contained in the Act for all forward-looking statements.

This press release discusses our product candidate, rademikibart, which is under clinical investigation and has not yet been approved for marketing by the U.S. Food and Drug Administration, the NMPA, or by any other regulatory agency. No representation is made as to the safety or effectiveness of rademikibart for the uses for which it is being studied. The trademarks included herein are the property of the owners thereof and are used for reference purposes only.

**Investor Relations Contact:** 

Alex Lobo

Precision AQ

Alex.Lobo@precisionaq.com

(212) 698-8802

**Media Contact:**

Ignacio Guerrero-Ros, Ph.D., or David Schull<br>Russo Partners, LLC<br>Ignacio.guerrero-ros@russopartnersllc.com <br>David.schull@russopartnersllc.com <br>(858) 717-2310 or (646) 942-5604

<br>