CASI Pharmaceuticals Receives CTA Approval From China's NMPA for CID-103 in Immune Thrombocytopenia
CASI Pharmaceuticals (NASDAQ:CASI) has received Clinical Trial Application (CTA) approval from China's NMPA to conduct a phase 1/2 study of CID-103 in adult patients with chronic Immune Thrombocytopenia (ITP). The China study is part of a global study previously approved by the US FDA in May 2024. CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody that has shown promising preclinical efficacy and safety compared to other anti-CD38 monoclonal antibodies.
CASI Pharmaceuticals (NASDAQ:CASI) ha ricevuto l'approvazione della Clinical Trial Application (CTA) dalla NMPA cinese per condurre uno studio di fase 1/2 su CID-103 in pazienti adulti affetti da trombocitopenia immunitaria cronica (ITP). Lo studio in Cina fa parte di uno studio globale precedentemente approvato dalla FDA degli Stati Uniti nel maggio 2024. CID-103 è un anticorpo monoclonale anti-CD38 IgG1 completamente umano che ha mostrato una promettente efficacia e sicurezza preclinica rispetto ad altri anticorpi monoclonali anti-CD38.
CASI Pharmaceuticals (NASDAQ:CASI) ha recibido la aprobación de la Clinical Trial Application (CTA) de la NMPA de China para llevar a cabo un estudio de fase 1/2 de CID-103 en pacientes adultos con trombocitopenia inmune crónica (ITP). El estudio en China es parte de un estudio global previamente aprobado por la FDA de EE. UU. en mayo de 2024. CID-103 es un anticuerpo monoclonal anti-CD38 IgG1 completamente humano que ha demostrado una prometedora eficacia y seguridad preclínica en comparación con otros anticuerpos monoclonales anti-CD38.
CASI Pharmaceuticals (NASDAQ:CASI)는 중국 NMPA로부터 만성 면역혈소판 감소증(ITP) 성인 환자를 대상으로 한 CID-103의 1/2상 연구를 수행할 Clinical Trial Application (CTA) 승인을 받았습니다. 중국 연구는 2024년 5월 미국 FDA에서 이전에 승인된 글로벌 연구의 일부입니다. CID-103은 다른 항-CD38 단클론 항체에 비해 유망한 전임상 효능과 안전성을 보여준 완전 인간 IgG1 항-CD38 단클론 항체입니다.
CASI Pharmaceuticals (NASDAQ:CASI) a reçu l'approbation de la Clinical Trial Application (CTA) de la NMPA chinoise pour mener une étude de phase 1/2 sur CID-103 chez des patients adultes atteints de thrombocytopénie immunitaire chronique (ITP). L'étude en Chine fait partie d'une étude mondiale précédemment approuvée par la FDA américaine en mai 2024. CID-103 est un anticorps monoclonal anti-CD38 IgG1 entièrement humain qui a montré une efficacité et une sécurité précliniques prometteuses par rapport à d'autres anticorps monoclonaux anti-CD38.
CASI Pharmaceuticals (NASDAQ:CASI) hat von der NMPA in China die Genehmigung für die Clinical Trial Application (CTA) erhalten, um eine Phase 1/2-Studie zu CID-103 bei erwachsenen Patienten mit chronischer Immunthrombozytopenie (ITP) durchzuführen. Die Studie in China ist Teil einer globalen Studie, die zuvor im Mai 2024 von der US-amerikanischen FDA genehmigt wurde. CID-103 ist ein vollständig humaner IgG1-anti-CD38-Monoklonantikörper, der im Vergleich zu anderen anti-CD38-Monoklonantikörpern vielversprechende präklinische Wirksamkeit und Sicherheit gezeigt hat.
- Received regulatory approval from China's NMPA for CID-103 clinical trials
- Expansion of global clinical program following previous FDA approval
- Promising preclinical efficacy and safety profile for CID-103
- None.
Insights
The CTA approval from China's NMPA marks a significant regulatory milestone for CASI's CID-103 development program. The expansion into China's market, following FDA clearance, creates a dual-market opportunity for this novel anti-CD38 monoclonal antibody. The ITP treatment landscape is currently dominated by medications like corticosteroids and TPO receptor agonists, leaving room for innovative therapies.
The unique epitope targeting of CID-103 could potentially translate to improved efficacy and safety compared to existing anti-CD38 antibodies. The global Phase 1/2 study approach indicates strong confidence in the drug's potential and could accelerate the development timeline. However, investors should note that early-stage clinical trials carry significant execution risks and substantial development costs.
BEIJING, CHINA / ACCESSWIRE / October 24, 2024 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a biopharmaceutical company specializing in the development and commercialization of innovative therapeutic and pharmaceutical products announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved the Company's Clinical Trial Application (CTA) to proceed with a phase 1/2 study of CID-103 in adults patients with chronic Immune Thrombocytopenia (ITP) in China. This China study is part of the global study that was approved by the US FDA in May 2024.
CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies.
Dr. Wei-Wu He, Chairman and CEO of CASI, said "Following the IND clearance by the FDA and the subsequent CTA approval in China, CASI continues to demonstrate its global commitment to develop innovative therapies to address unmet medical need in autoimmune diseases. We're optimistic that CID-103 could offer a promising new treatment option for ITP patients."
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing, and commercializing products that augment its focus on hematology oncology therapeutics and therapeutics for organ transplant rejection and autoimmune disease, as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the Greater China market, leveraging the Company's China-based regulatory and commercial competencies and its global drug development expertise. The Company's operations in China are conducted through its wholly owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., located in Beijing, China. More information on CASI is available at www.casipharmaceuticals.com.
CASI Forward-Looking Statements
This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Among other things, the business outlook and quotations from management in this announcement, as well as the Company's strategic and operational plans, contain forward-looking statements. The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the "SEC"), in in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: uncertainties related to the non-binding proposal to acquire the Company's certain business operations in China; the risk that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; the possibility that we may be delisted from trading on The Nasdaq Capital Market if we fail to satisfy applicable continued listing standards; the volatility in the market price of our ordinary shares; the risk of substantial dilution of existing shareholders in future share issuances; the difficulty of executing our business strategy on a global basis including China; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; legal or regulatory developments in China that adversely affect our ability to operate in China, our lack of experience in manufacturing products and uncertainty about our resources and capabilities to do so on a clinical or commercial scale; risks relating to the commercialization, if any, of our products and proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); our inability to predict when or if our product candidates will be approved for marketing by the U.S. Food and Drug Administration, European Medicines Agency, PRC National Medical Products Administration, or other regulatory authorities; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; the risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; the risks associated with our product candidates, and the risks associated with our other early-stage products under development; the risk that result in preclinical and clinical models are not necessarily indicative of clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; our ability to protect our intellectual property rights; the lack of success in the clinical development of any of our products; and our dependence on third parties; the risks related to our dependence on Juventas to conduct the clinical development of CNCT19 and to partner with us to co-market CNCT19; risks related to our dependence on Juventas to ensure the patent protection and prosecution for CNCT19; the risk related to the Company's ongoing development of and regulatory application for CID-103 with respect to the treatment of antibody-mediated rejection for organ transplant and the license arrangements of CID-103; risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); risks relating to interests of our largest shareholder and our Chairman and CEO that differ from our other shareholders; and risks related to the development of a new manufacturing facility by CASI Pharmaceuticals (Wuxi) Co., Ltd. Further information regarding these and other risks is included in the Company's filings with the SEC. All information provided herein is as of the date of this announcement, and the Company undertakes no obligation to update any forward-looking statement, except as required under applicable law.
EVOMELA® is proprietary to Acrotech Biopharma Inc. and its affiliates. FOLOTYN®is proprietary to Acrotech Biopharma Inc and its affiliates.
COMPANY CONTACT:
Rui Zhang
CASI Pharmaceuticals, Inc.
240.864.2643
ir@casipharmaceuticals.com
SOURCE: CASI Pharmaceuticals, Inc.
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FAQ
What regulatory approval did CASI Pharmaceuticals receive for CID-103 in October 2024?
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