On November 21, 2023, the Company announced that two of its wholly owned subsidiaries, Connect Biopharma HongKong Limited (“Connect HK”) and Suzhou Connect Biopharma Co., Ltd. (“Connect SZ” and, together with Connect HK, the “Licensor”), have entered into an exclusive license and collaboration agreement with Simcere Pharmaceutical Co., Ltd. (the “Licensee”), a subsidiary of Simcere Pharmaceutical Group Ltd to develop and commercialize Connect Biopharma’s rademikibart in Greater China.
Under the agreement, the Licensor will complete all of rademikibart’s ongoing China clinical trials and related analysis in atopic dermatitis (AD), which is on track for a new drug application submission for AD in China by the end of Q1 2024. The Licensee has been granted exclusive rights to develop, manufacture and commercialize rademikibart for all indications in Greater China, including mainland China, Hong Kong, Macau, and Taiwan, while the Licensor retains rights in all other markets. The Licensee will be responsible for rademikibart’s new drug application for AD in China and will also conduct and be responsible for the costs of all future clinical studies in all additional disease indications for rademikibart in Greater China.
According to the terms of the agreement, the Licensor will receive a ¥150 million RMB (US$21 million) upfront payment, up to ¥875 million RMB (US$120 million) upon achieving certain development and commercial milestones, in addition to royalties up to low double-digit percentages of net sales. The translation from renminbi to U.S. dollars was made at RMB 7.3166 to US$1.00, representing the exchange rate as of October 31, 2023 set forth in the China Foreign Exchange Trade System.
The description of the Exclusive License and Collaboration Agreement is qualified in its entirety by the Exclusive License and Collaboration Agreement, the English translation of which is furnished herewith as Exhibit 99.1, and incorporated herein by reference.
Other Events.
On November 21, 2023, the Company announced positive topline results from the Stage 2 (maintenance period) of its China pivotal trial evaluating rademikibart’s (formerly known as CBP-201) efficacy and safety in patients with moderate-to-severe AD. These results follow the previously reported Stage 1 results of the trial, which met all primary and key secondary endpoints.
Positive Stage 2 results at Week 52 show the potential of rademikibart as a Q4W treatment for AD
In Stage 2, patients that achieved EASI-50 (responders) regardless of initial treatment in the 16-week Stage 1 were randomized to either dosing every two weeks (“Q2W”) rademikibart (n=113) or dosing every four weeks (“Q4W”) rademikibart (n=112) arms. Patients that did not achieve EASI-50 (non-responders) were assigned to an open label Q2W rademikibart arm (n=86).
An efficacy analysis in patients that achieved Investigator’s Global Assessment scale (“IGA”) 0/1 or Eczema Area and Severity Index (“EASI”)-75 at Week 16, showed that with both Q2W at Q4W dosing regimens, 76%-87% of them maintained their IGA 0/1 and 92% of patients maintained their EASI-75 at Week 52, respectively.
Rademikibart Week 52 Results
In patients that achieved IGA 0/1 or EASI-75 at Week 16
Rademikibart
300 mg Q4W
Rademikibart
300 mg Q2W
IGA 0/1 with
≥2-point reduction
87.2%
(n=40)
76.0%
(n=34)
EASI-75
91.9%
(n=79)
91.7%
(n=76)
Evaluation of all patients that achieved EASI-50 at Week 16 with rademikibart (active drug responders) showed continued improvement from Week 16 to Week 52. 21%-28% more patients achieved IGA 0/1, and 11%-16% more patients achieved EASI-75 at Week 52.
Rademikibart Week 52 Results
In patients that achieved EASI-50 at Week 16
Rademikibart
300 mg Q4W (n=91)
Rademikibart
300 mg Q2W (n=91)
Week 16
Week 52
Week 16
Week 52
IGA 0/1 with
≥2-point reduction
41.8%
62.6%
30.9%
59.1%
EASI-75
73.6%
84.6%
68.5%
84.8%
Additionally, of the patients who achieved a clinically meaningful ≥4-point reduction in peak pruritus numerical rating scale (“PP-NRS”), 95.2% were able to maintain that level with Q4W dosing and 81.6% with Q2W dosing at the end of the study. With respect to quality of life, a ≥5-point reduction on the dermatology life quality index (“DLQI”) is considered clinically important and 93.4% (Q2W) and 90.0% (Q4W) were able to maintain this level at the end of the 52-week study.
Treatment with 300 mg Q2W and Q4W of rademikibart was generally well tolerated, and there were no new safety signals. There was only one patient discontinuation due to an adverse event (pregnancy) in the rademikibart Q2W open label arm.
On November 21, 2023, the Company issued the press release attached hereto as Exhibit 99.2. The furnishing of the attached press releases is not an admission as to the materiality of any information therein. The information contained in the press releases is summary information that is intended to be considered in the context of more complete information included in the Company’s filings with the SEC and other public announcements that the Company has made and may make from time to time. The Company undertakes no duty or obligation to update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing or furnishing of other reports or documents with the SEC or through other public disclosures.
The information in the paragraphs above under “Information Contained in this Report on Form 6-K” in this Report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form F-3 (File No. 333-264340) and Form S-8 (File Nos. 333-254254 and 333-266006) of the Company, filed with the Securities and Exchange Commission, and to be a part thereof from the date on which this report is furnished, to the extent not superseded by documents or reports subsequently filed or furnished.
Forward-Looking Statements
