RAPT Therapeutics and Shanghai Jemincare Pharmaceutical Announce Exclusive License Agreement for Novel Long-Acting anti-IgE Antibody
RAPT Therapeutics and Shanghai Jemincare Pharmaceutical have entered into an exclusive license agreement for JYB1904 (RPT904), a clinical-stage anti-IgE antibody. RAPT obtains worldwide rights excluding China, Hong Kong, Macau, and Taiwan for a $35 million upfront payment, up to $672.5 million in milestone payments, and high single-digit to low-double digit royalties.
RPT904 is being developed as a potential improvement over omalizumab (Xolair®), targeting the same epitope but with an extended half-life. Jemincare's Phase 1 study showed good safety profile and a half-life more than twice that of omalizumab. RAPT plans to initiate a Phase 2b trial in food allergy in the second half of 2025, while Jemincare is conducting Phase 2 trials in asthma and chronic spontaneous urticaria in China.
RAPT Therapeutics e Shanghai Jemincare Pharmaceutical hanno firmato un accordo di licenza esclusiva per JYB1904 (RPT904), un anticorpo anti-IgE in fase clinica. RAPT ottiene i diritti globali escludendo Cina, Hong Kong, Macao e Taiwan per un pagamento iniziale di 35 milioni di dollari, fino a 672,5 milioni di dollari in pagamenti di traguardo, e royalties in percentuali elevate a una cifra singola fino a basse cifre doppie.
RPT904 è in fase di sviluppo come un potenziale miglioramento rispetto all'omalizumab (Xolair®), mirando allo stesso epitopo ma con una vita media prolungata. Lo studio di Fase 1 di Jemincare ha mostrato un buon profilo di sicurezza e una vita media più di due volte superiore a quella dell'omalizumab. RAPT prevede di avviare un studio di Fase 2b sulle allergie alimentari nella seconda metà del 2025, mentre Jemincare sta conducendo studi di Fase 2 sull'asma e l'urticaria cronica spontanea in Cina.
RAPT Therapeutics y Shanghai Jemincare Pharmaceutical han firmado un acuerdo de licencia exclusiva para JYB1904 (RPT904), un anticuerpo anti-IgE en etapa clínica. RAPT obtiene derechos mundiales excluyendo China, Hong Kong, Macao y Taiwán por un pago inicial de 35 millones de dólares, hasta 672,5 millones de dólares en pagos por hitos, y regalías de un solo dígito alto a bajo dígito doble.
RPT904 se está desarrollando como una posible mejora sobre el omalizumab (Xolair®), dirigido al mismo epítopo pero con una vida media extendida. El estudio de Fase 1 de Jemincare mostró un buen perfil de seguridad y una vida media más de dos veces superior a la del omalizumab. RAPT planea iniciar un ensayo de Fase 2b en alergias alimentarias en la segunda mitad de 2025, mientras Jemincare está llevando a cabo ensayos de Fase 2 en asma y urticaria crónica espontánea en China.
RAPT Therapeutics와 Shanghai Jemincare Pharmaceutical는 임상 단계의 항체인 JYB1904 (RPT904)에 대한 독점 라이선스 계약을 체결했습니다. RAPT는 중국, 홍콩, 마카오 및 대만을 제외한 전 세계 권리를 3,500만 달러의 선불 지급과 최대 6억 7,250만 달러의 이정표 지급, 그리고 높은 단일 수치부터 낮은 이중 수치의 로열티를 포함하여 확보합니다.
RPT904는 옴알리주맙(Xolair®)보다 개선된 잠재력을 가지고 개발되고 있으며, 동일한 에피트로를 목표로 하지만 반감기가 연장되었습니다. Jemincare의 1상 연구는 좋은 안전성 프로필과 옴알리주맙보다 두 배 이상 긴 반감기를 보여주었습니다. RAPT는 2025년 하반기에 식품 알레르기 관련 2b상 시험을 시작할 계획이며, Jemincare는 중국에서 천식 및 만성 자발성 담반에 대한 2상 시험을 진행하고 있습니다.
RAPT Therapeutics et Shanghai Jemincare Pharmaceutical ont conclu un accord de licence exclusif pour JYB1904 (RPT904), un anticorps anti-IgE en phase clinique. RAPT obtient les droits mondiaux, à l'exception de la Chine, Hong Kong, Macao et Taïwan, pour un paiement initial de 35 millions de dollars, jusqu'à 672,5 millions de dollars en paiements d'étape et des redevances à deux chiffres basses à élevées.
RPT904 est en cours de développement comme une amélioration potentielle par rapport à l'omalizumab (Xolair®), ciblant le même épitope mais avec une demi-vie prolongée. L'étude de phase 1 de Jemincare a montré un bon profil de sécurité et une demi-vie plus de deux fois celle de l'omalizumab. RAPT prévoit de commencer un essai de phase 2b sur les allergies alimentaires au cours de la seconde moitié de 2025, tandis que Jemincare mène des essais de phase 2 sur l'asthme et l'urticaire chronique spontanée en Chine.
RAPT Therapeutics und Shanghai Jemincare Pharmaceutical haben eine exklusive Lizenzvereinbarung für JYB1904 (RPT904), einen Antikörper gegen IgE in der klinischen Phase, abgeschlossen. RAPT erhält weltweite Rechte, mit Ausnahme von China, Hongkong, Macao und Taiwan, für eine Vorauszahlung von 35 Millionen US-Dollar, bis zu 672,5 Millionen US-Dollar an Meilensteinzahlungen und hohe Einzel- bis niedrige Doppelzahlen an Lizenzgebühren.
RPT904 wird als mögliche Verbesserung gegenüber Omalizumab (Xolair®) entwickelt, das dasselbe Epitop anvisiert, jedoch mit einer verlängerten Halbwertszeit. Die Phase-1-Studie von Jemincare zeigte ein gutes Sicherheitsprofil und eine mehr als doppelt so lange Halbwertszeit wie Omalizumab. RAPT plant, in der zweiten Hälfte des Jahres 2025 eine Phase-2b-Studie zu Nahrungsmittelallergien zu starten, während Jemincare Phase-2-Studien zu Asthma und chronischer spontaner Urtikaria in China durchführt.
- Secured worldwide rights (excluding China region) for a clinical-stage anti-IgE antibody
- Phase 1 results showed doubled half-life compared to competitor omalizumab
- Product demonstrated deeper and more sustained reduction of free IgE compared to omalizumab
- Targeting established market with proven commercial potential (following omalizumab's success)
- Substantial upfront payment of $35 million required
- Phase 2b trials won't start until H2 2025
- Royalty payments will impact future revenue margins
Insights
This strategic licensing deal marks a significant expansion of RAPT's portfolio with RPT904, a potential best-in-class anti-IgE antibody. The
The demonstrated superior half-life and pharmacodynamics compared to Xolair® (omalizumab) in Phase 1 trials suggests strong commercial potential. The food allergy market, where Xolair® recently gained approval, represents a lucrative opportunity with high unmet needs. The timing of planned Phase 2b trials in H2 2025 positions RAPT to potentially capture market share in this growing segment.
The preliminary clinical data for RPT904 is compelling, showing more than double the half-life of omalizumab and superior pharmacodynamic profile with deeper, more sustained free IgE reduction. These characteristics could translate to less frequent dosing and better patient compliance. The ongoing Phase 2 trials in asthma and CSU in China will provide important efficacy data by 2026, potentially de-risking future development in additional indications.
The molecule's targeting of the same validated epitope as omalizumab, combined with enhanced pharmacological properties, suggests a lower development risk profile. The planned food allergy trial leverages recent regulatory precedent from omalizumab's approval, potentially streamlining the development pathway.
The commercial positioning of RPT904 is strategically sound, targeting the rapidly growing food allergy market where Xolair® has already established proof of concept. The improved half-life profile could lead to competitive advantages in pricing and market access. The high single-digit to low double-digit royalty structure on future sales provides meaningful revenue potential while maintaining profitability margins.
The partnership with Jemincare effectively splits development costs and risks while maintaining rights in major markets. The concurrent development in multiple indications (food allergy, asthma, CSU) could accelerate market penetration and expand the total addressable market substantially.
- RAPT obtains worldwide rights excluding China -
- Jemincare receives
- Jemincare is currently conducting Phase 2 trials in asthma and chronic spontaneous urticaria in China -
- RAPT plans to initiate Phase 2b trial in food allergy next year -
- RAPT to host a conference call at 8:30 a.m. ET -
SOUTH SAN FRANCISCO, Calif., Dec. 23, 2024 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients with significant unmet needs in inflammatory diseases, and Shanghai Jemincare Pharmaceutical Co., Ltd (“Jemincare”), a subsidiary of Jiangxi Jemincare Group, a leading pharmaceutical company in China, today announced they have entered into an exclusive license agreement for JYB1904 (RAPT designation RPT904), a clinical-stage, half-life extended anti-immunoglobulin E (IgE) monoclonal antibody. Under the terms of the license agreement, RAPT is granted worldwide rights excluding mainland China, Hong Kong, Macau and Taiwan (together, the “Jemincare Territory”) to develop and commercialize RPT904. As consideration for the license, Jemincare receives a
“We’re delighted to partner with Jemincare and excited by RPT904 and its potential to be a novel best-in-class treatment option for patients with food allergy. Omalizumab’s rapid uptake in food allergy since its approval earlier this year confirms the high unmet need and large opportunity in this growing market,” commented Brian Wong, M.D., Ph.D., President and CEO of RAPT. “RPT904 targets the same clinically validated epitope as omalizumab and combined with extended half-life, gives this molecule a best-in-class profile. We plan to initiate a Phase 2b clinical trial of RPT904 in food allergy in the second half of 2025.”
“We are delighted to be working with RAPT Therapeutics to advance development of JYB1904 in food allergy and other allergic disorders. We trust this partnership could significantly enhance and accelerate the development and potential commercialization of JYB1904 to benefit patients,” commented Xiaoxiang Li, President of Jemincare.
Jemincare has completed a randomized, double-blinded, Phase 1 single-dose dose-escalation study in 56 healthy volunteers in China focused on safety, pharmacokinetics (“PK”) and pharmacodynamics (“PD”). Five dose levels of JYB1904 and one dose level of omalizumab were compared to placebo. Overall safety and tolerability of JYB1904 was good, and all treatment-related adverse events were Grade 1-2. The pharmacokinetics of JYB1904 were approximately dose-proportional, and the median half-life of JYB1904 was more than two times that of omalizumab at the same dose. The Phase 1 study also showed deeper and more sustained reduction of free IgE and higher total IgE accumulation by JYB1904 compared to omalizumab at the same dose.
Jemincare is currently conducting two Phase 2 trials of JYB1904 in China. The Phase 2 trial in asthma is primarily focused on PK and PD profiles compared to omalizumab to help inform dosing for a potential Phase 3 registrational trial. Jemincare expects to have topline data from the Phase 2 asthma trial in the second half of 2025. The Phase 2 trial in CSU is focused on evaluating safety and efficacy, and Jemincare expects to have topline data from this trial in the first half of 2026.
Webcast Conference Call Information
RAPT will host a webcast conference call today, December 23, 2024 at 8:30 a.m. ET. To join the conference call via phone and participate in the live Q&A session, please pre-register online here to receive a telephone number and unique passcode required to enter the call. The live webcast and audio archive of the presentation may be accessed on the RAPT Therapeutics website at https://investors.rapt.com/events-and-presentations.
About JYB1904/RPT904
JYB1904/RPT904 is a novel, half-life extended anti-IgE monoclonal antibody (mAb) for the treatment of patients with food allergies, chronic spontaneous urticaria and other allergic inflammatory diseases. RPT904 is designed to bind free human immunoglobulin E (IgE), a key driver of allergic diseases, and in early clinical studies has demonstrated more than twice the half-life, as well as extended pharmacokinetics and pharmacodynamic properties, compared to omalizumab (Xolair®), a first generation anti-IgE mAb.
About RAPT Therapeutics, Inc.
RAPT Therapeutics is a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing therapies for patients with significant unmet needs in inflammatory diseases. The company leverages its proprietary discovery and development platform to advance both biologics and selective small molecules aimed at normalizing critical immune drivers underlying these conditions.
About Jemincare
Jiangxi Jemincare Group Co., Ltd. is a leading pharmaceutical company from China. Founded in 1999, Jemincare is mainly engaged in the pharmaceutical industry. The company is dedicated to the development, manufacturing and commercialization of therapeutics in its strategic fields including oncology, nephrology, cerebro-cardiovascular, anti-infection, analgesic, respiratory and Pediatrics. Shanghai Jemincare Pharmaceutical Co., Ltd is the R&D center of Jiangxi Jemincare Group Co., Ltd. Shanghai Jemincare has developed a strong scientific team with end-to-end drug discovery and development capability. More than 10 programs have entered clinical stage from Jemincare’s in-house pipeline. For more information, please visit www.jemincare.com
RAPT Forward-Looking Statements
This press release contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future performances or achievements expressed or implied by the forward-looking statements. Each of these statements is based only on current information, assumptions and expectations that are inherently subject to change and involve a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements about the licensing agreement and potential future milestone payments and royalties; the company’s business and clinical development plans, including plans to develop RPT904 and associated clinical trial and development timelines; the potential therapeutic potential of RPT904; the potential commercial opportunity for RPT904; the ability to obtain necessary regulatory approvals and other statements that are not historical fact. Factors that may cause actual results to differ materially from the plans, intentions and expectations disclosed in these forward-looking statements include uncertainties inherent in the initiation, progress and completion of clinical trials and clinical development of RAPT’s product candidates; the risk that clinical trials may have unsatisfactory outcomes; risks associated with preclinical development of product candidates; risks that efforts to secure licensing and other business development opportunities may not be successful; and other important factors, detailed in RAPT’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, and subsequent filings made by RAPT with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. RAPT disclaims any obligation to update these forward-looking statements.
Investor Contact:
Sylvia Wheeler
swheeler@wheelhouselsa.com
Media Contact:
Aljanae Reynolds
areynolds@wheelhouselsa.com
FAQ
What are the financial terms of RAPT's license agreement with Jemincare for RPT904?
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When will RAPT Therapeutics begin Phase 2b trials for RPT904 in food allergy?
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