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
Connect Biopharma (NASDAQ:CNTB) announced that its Chinese partner Simcere Pharmaceutical has submitted a New Drug Application (NDA) to China's NMPA for rademikibart, targeting atopic dermatitis treatment in adults and adolescents.
The submission follows a 2023 exclusive licensing agreement where Simcere acquired rights to develop, manufacture, and commercialize rademikibart in Greater China. Connect remains eligible for up to $110 million in milestone payments plus tiered royalties up to low double-digit percentages on net sales. The opportunity is significant, with an estimated 70 million atopic dermatitis patients in China.
Connect Biopharma (NASDAQ:CNTB) ha annunciato che il suo partner cinese, Simcere Pharmaceutical, ha presentato una domanda di nuovo farmaco (NDA) all'NMPA cinese per rademikibart, destinato al trattamento della dermatite atopica in adulti e adolescenti.
La presentazione segue un accordo di licenza esclusiva del 2023 con cui Simcere ha acquisito i diritti per sviluppare, produrre e commercializzare rademikibart nella Grande Cina. Connect rimane idonea a ricevere fino a 110 milioni di dollari in pagamenti legati a obiettivi oltre a royalties a scaglioni che possono arrivare a percentuali a una cifra bassa doppia sui ricavi netti. L'opportunità è rilevante, considerando gli stimati 70 milioni di pazienti con dermatite atopica in Cina.
Connect Biopharma (NASDAQ:CNTB) anunció que su socio chino, Simcere Pharmaceutical, ha presentado una Solicitud de Nuevo Medicamento (NDA) a la NMPA de China para rademikibart, destinado al tratamiento de la dermatitis atópica en adultos y adolescentes.
La presentación se produce tras un acuerdo de licencia exclusiva de 2023 mediante el cual Simcere adquirió los derechos para desarrollar, fabricar y comercializar rademikibart en la Gran China. Connect sigue siendo elegible para recibir hasta 110 millones de dólares en pagos por hitos además de regalías escalonadas que pueden alcanzar un porcentaje bajo de dos dígitos sobre las ventas netas. La oportunidad es significativa, con un estimado de 70 millones de pacientes con dermatitis atópica en China.
Connect Biopharma (NASDAQ:CNTB)는 중국 파트너인 Simcere Pharmaceutical가 성인 및 청소년의 아토피 피부염 치료를 위한 라데미키바트(rademikibart)에 대해 중국 NMPA에 신약 허가 신청서(NDA)를 제출했다고 발표했습니다.
이번 제출은 2023년 체결된 독점 라이선스 계약에 따른 것으로, Simcere는 중화권에서 라데미키바트를 개발, 제조 및 상업화할 권리를 획득했습니다. Connect는 최대 1억 1천만 달러의 마일스톤 지급금과 순매출에 대해 낮은 두 자릿수 비율의 단계별 로열티를 받을 자격이 있습니다. 중국 내 아토피 피부염 환자가 약 7천만 명으로 추산되어 큰 기회가 예상됩니다.
Connect Biopharma (NASDAQ:CNTB) a annoncé que son partenaire chinois, Simcere Pharmaceutical, a soumis une demande d'autorisation de mise sur le marché (NDA) auprès de la NMPA chinoise pour le rademikibart, destiné au traitement de la dermatite atopique chez les adultes et les adolescents.
Cette soumission fait suite à un accord de licence exclusive en 2023 par lequel Simcere a acquis les droits de développement, de fabrication et de commercialisation du rademikibart en Grande Chine. Connect reste éligible à recevoir jusqu'à 110 millions de dollars en paiements d'étapes ainsi que des redevances échelonnées pouvant atteindre des pourcentages à un chiffre bas sur les ventes nettes. L'opportunité est importante, avec environ 70 millions de patients atteints de dermatite atopique en Chine.
Connect Biopharma (NASDAQ:CNTB) gab bekannt, dass sein chinesischer Partner Simcere Pharmaceutical einen Antrag auf Zulassung eines neuen Medikaments (NDA) bei der chinesischen NMPA für Rademikibart eingereicht hat, das zur Behandlung der atopischen Dermatitis bei Erwachsenen und Jugendlichen vorgesehen ist.
Die Einreichung erfolgt nach einer exklusiven Lizenzvereinbarung aus dem Jahr 2023, bei der Simcere die Rechte zur Entwicklung, Herstellung und Vermarktung von Rademikibart im Großraum China erworben hat. Connect bleibt berechtigt, bis zu 110 Millionen US-Dollar an Meilensteinzahlungen sowie gestaffelte Lizenzgebühren in niedrigen zweistelligen Prozentsätzen auf den Nettoumsatz zu erhalten. Die Chance ist bedeutend, mit geschätzten 70 Millionen Patienten mit atopischer Dermatitis in China.
- Potential milestone payments up to $110 million plus tiered royalties up to low double-digits
- Large market opportunity with 70 million atopic dermatitis patients in China
- NDA submission represents significant regulatory progress
- Additional potential in asthma and chronic obstructive pulmonary disease indications
- Regulatory approval still pending and success not guaranteed
- Commercialization timeline and market penetration uncertain
Insights
Connect Biopharma's Chinese partner submitted NDA for atopic dermatitis drug; potential milestone payments of $110M plus royalties await approval.
The submission of a New Drug Application (NDA) by Simcere for rademikibart represents a significant regulatory milestone for Connect Biopharma in the Chinese market. This IL-4Rα antibody targeting atopic dermatitis (AD) is positioned in a therapeutic class that has shown substantial efficacy in treating inflammatory skin conditions.
The deal structure provides Connect with considerable upside potential without bearing the costs and risks of commercialization in China. The agreement includes up to $110 million in remaining milestone payments plus tiered royalties reaching low double-digit percentages on net sales. Given China's estimated 70 million AD patients, this represents a substantial commercial opportunity.
Strategically, this licensing approach allows Connect to maintain focus on other markets while leveraging Simcere's established presence in China to navigate the complex regulatory environment and commercialization landscape. The submission suggests that clinical data has been sufficiently promising to warrant regulatory review. The broader pipeline strategy targeting multiple inflammatory conditions (AD, asthma, COPD) with the same molecule demonstrates a platform approach that could maximize the drug's commercial potential across indications.
While approval isn't guaranteed, this NDA submission significantly derisks Connect's China strategy and moves them one step closer to potential revenue generation in one of the world's largest pharmaceutical markets.
SAN DIEGO, July 09, 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
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.
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FAQ
What is the status of Connect Biopharma's (CNTB) rademikibart drug application in China?
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