ROCKVILLE, Md.

and

BEIJING

,

Dec. 10, 2021

/PRNewswire/ — CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announces that the China National Medical Products Administration (NMPA) has approved the Company’s Clinical Trial Application (CTA) for BI-1206, a First-in-class fully human monoclonal antibody (“mAb”) that targets FcγRIIB. CASI is planning Phase 1 trials of BI-1206 as a single agent to evaluate the PK/safety profile and in combination with rituximab in NHL (mantle cell lymphoma, marginal zone lymphoma, and follicular lymphoma) to assess safety and tolerability, select the Recommended Phase 2 Dose and assess early signs of clinical efficacy as part of its development program for BI-1206 in

China

. The studies are expected to start in 1H 2022.

Wei-Wu He

, Ph.D., CASI’s Chairman, and Chief Executive Officer, commented, “We are excited about the approval of BI-1206’s CTA application in

China

. This approval is an important step closer to making BI-1206, a first-in-class molecule, available to patients and healthcare providers across

Greater China

.  Our partner, BioInvent, has shown promising clinical data in Phase 1/2a clinical trial in combination with rituximab (anti-CD20 monoclonal antibody) in patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL) and will be presenting an update at ASH 2021. CASI is responsible for conducting the studies in

China

, and will initiate these important clinical trials as soon as possible. We are excited to be able to accelerate the development of BI-1206 in

China

and contribute to its global development.”

Alexander Zukiwski

, M.D., CASI’s Chief Medical Officer continued, “With the CTA application submitted on

September 29


^th

, 2021, the rapid NMPA review and approval, allows CASI to quickly progress both of the BI-1206 Phase 1 clinical studies in

China

; and in collaboration with BioInvent, we are looking forward to our participation in the future global clinical development program.”

Martin Welschof, CEO of BioInvent commented, “We are very pleased to see the first fruit of our development collaboration with CASI on BI-1206. As BioInvent develops the molecule across

Europe

and the US, our Asian partnership with CASI adds significant shareholder value to the company. Our expanding pipeline of first-in-class immunotherapies creates multiple development and commercial opportunities for the company and its partners.”

About BI-1206 (Anti-FcyRIIB antibody)

BI-1206 has a novel mode-of-action, blocking the single inhibitory antibody checkpoint receptor FcγRIIB to unlock anti-cancer immunity in both liquid and solid tumors. Fcγ receptors are “antibody checkpoints” that modulate efficacy of tumor-cell direct-targeting antibodies and immune checkpoint-targeting antibodies used in cancer immunotherapy. BI-1206 can potentially be used with all therapeutic mAbs that rely on ADCC/CDC for efficacy.

BI-1206 is a high-affinity monoclonal antibody that selectively binds to FcγRIIB (CD32B), the only inhibitory member of the FcγR family. FcγRIIB is overexpressed in several forms of NHL and overexpression has been associated with poor prognosis in difficult-to-treat forms of NHL, such as mantle cell lymphoma. By blocking FcγRIIB, BI-1206 is expected to recover and enhance the activity of rituximab or other anti-CD20 monoclonal antibodies in the treatment of these diseases. The combination of the two drugs could provide a new and important option for patients suffering from NHL, and represents a substantial commercial opportunity.

BI-1206 is BioInvent’s lead drug candidate and is currently being investigated in two Phase 1/2 trials. One is evaluating the BI-1206 combination with rituximab for the treatment of non-Hodgkin’s lymphoma; and the other evaluates BI-1206 in combination with anti-PD1 therapy Keytruda® (pembrolizumab) in solid tumors.

BioInvent and CASI have an exclusive licensing agreement for the development and commercialization of BI-1206 in mainland

China

,

Taiwan

,

Hong Kong

and

Macau

in both liquid and solid cancers, with CASI responsible for commercialization in

China

and associated markets. BioInvent is eligible to receive up to

$83 million

in development and commercial milestone payments plus tiered royalties in the high-single to mid-double-digit range on net sales of BI-1206.

About BioInvent

BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently three drug candidates in four ongoing clinical programs in Phase l/ll trials for the treatment of hematological cancer and solid tumors, respectively and a fifth program just initiating clinical development. The Company’s validated, proprietary F.I.R.S.T™ technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline or for additional licensing and partnering.

The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company’s fully integrated manufacturing unit. More information is available at www.bioinvent.com.

About CASI Pharmaceuticals

CASI Pharmaceuticals, Inc. (NASDAQ: CASI) is a U.S. 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 hematology oncology therapeutic focus 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., which is located in

Beijing, China

. The Company has built a commercial team of more than 100 hematology oncology sales and marketing specialists based in

China

. More information on CASI is available at

www.casipharmaceuticals.com

.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance, revenue growth, strategies, expectations and goals. Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and we assume no duty to update forward-looking statements. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Actual results could differ materially from those currently anticipated due to a number of factors.

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SOURCE CASI Pharmaceuticals, Inc.