Tegafur/Gimeracil/Oteracil Potassium

YANTAI, China, June 5, 2024 /PRNewswire/ -- RemeGen Co., Ltd. ("RemeGen" or "the Company") (9995.HK, SHA: 688331), a commercial-stage biotechnology company, showcased its innovation in the field of global cancer treatment at the American Society of Clinical Oncology Annual Meeting (ASCO 2024) held in Chicago from May 31-June 4, 2024, sharing major research results including its proprietary antibody drug conjugates (ADCs) Disitamab Vedotin (RC48) and RC88. RemeGen's innovative drugs featured in one Clinical Science Symposium, five Poster presentations, and ten online Abstracts at ASCO 2024, covering multiple cancer types including gastric and bladder cancer, and gynecological tumors in studies that included both monotherapy and combination therapies. Dr. Jianmin Fang, CEO of RemeGen, commented, "It is always such an honor to present our latest research findings on an internationally renowned stage such as ASCO Annual Meeting 2024. This not only demonstrates RemeGen's leading position in the field of antibody-drug conjugates in China but also proves our commitment to continuing our research efforts to provide effective treatment options for patients worldwide." Clinical Science Symposium First author Professor Song Li from Qilu Hospital of Shandong University gave an oral presentation at a Clinical Science Symposium at ASCO 2024 based on a randomized, controlled (RCT) multicenter, single-arm, Phase II trial investigating the efficacy of RemeGen's disitamab vedotin (RC48) combined with toripalimab and the oral fluoropyrimidine S-1 in first-line HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma. Poster Sessions First author Professor Sheng Xinan from Peking University Cancer Hospital presented RemeGen's poster session (Poster #263) of a Phase II study of neoadjuvant treatment with disitamab vedotin plus toripalimab in patients with HER2-expressing muscle-invasive bladder cancer (MIBC) focusing on the preliminary efficacy and safety results of RC48-C017. The standard of care for MIBC is neoadjuvant cisplatin-based chemotherapy followed by radical cystectomy plus pelvic lymph node dissection (RC + PLND). Disitamab vedotin monotherapy, or combined therapy with toripalimab, showed promising anti-tumor activity in metastatic urothelial carcinoma. This Phase II trial aimed to evaluate the safety and efficacy of disitamab vedotin plus toripalimab as perioperative therapy in MIBC patients and the interim results presented at ASCO showed promising efficacy results with a manageable safety profile in operable MIBC patients. These results support further investigation for disitamab vedotin plus toripalimab in this population. Other poster presentations included a Phase II multi-center study in poster session (poster #311a) on adjuvant or rescue disitamab vedotin (RC48-ADC) for high-risk non-muscle invasive bladder cancer with HER2 expression; and a prospective, single-arm, single-center clinical study in poster session (poster #513a) on disitamab vedotin combined with toripalimab in patients with advanced penile cancer who have progressed on treatment or are intolerant to cisplatin chemotherapy. Online Abstract Publications Ten other online abstracts accepted by ASCO reflected results of RemeGen's RC48 and RC88 in bladder, breast, and GI cancers, demonstrating the Company's prolific innovation in global cancer treatment. About ASCO The ASCO 2024 meeting is the premier event for strategies to improve quality care in oncology. It provides superb panels featuring experts who are leading and implementing innovative programs focused on value. ASCO's diverse network of nearly 42,350 oncology professionals recognizes ASCO's dedication to providing the highest-quality resources in education, policy, the pioneering of clinical research, and above all, advancing the care for patients with cancer. About RemeGen Co. Ltd. Founded in 2008, RemeGen (9995.HK, SHA: 688331) is a leading biopharmaceutical company in China committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices throughout China and the United States. The company is committed to discovering, developing, and commercializing innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology, and ophthalmic diseases. For more details, please visit: About Disitamab Vedotin (RC48) Disitamab Vedotin (RC48) is an investigational anti-HER2 antibody-drug conjugate targeting prevalent solid cancers with significant unmet medical needs and is the first domestically developed ADC to receive marketing approval in China. The company is implementing a differentiated development and commercial strategy for disitamab vedotin, including (i) gastric cancer (GC), (ii) urothelial carcinoma (UC), (iii) breast cancer (BC), and (iv) other HER2-expressing cancers. SOURCE RemeGen Co., Ltd

CHARLOTTESVILLE, Va., March 01, 2024 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced the entry into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 1,150,000 shares of common stock of the Company originally issued in October 2023, having an exercise price of $2.82 per share and eighteen months term. The shares of common stock issuable upon exercise of the warrants are registered pursuant to an effective registration statement on Form S-1 (No. 333-275397). The gross proceeds to the Company from the exercise of the warrants are expected to be $3,530,500, prior to deducting placement agent fees and estimated offering expenses. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. In consideration for the immediate exercise of the warrants for cash and the payment of $0.125 per new warrant, the Company will issue new unregistered warrants to purchase up to 2,300,000 shares of common stock. The new warrants will have an exercise price of $2.82 per share, will be immediately exercisable upon issuance and will have a term of eighteen months from the issuance date. The offering is expected to close on or about March 6, 2024, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds for general corporate purposes, including general and administrative expenses, working capital and to support regulatory and clinical activities related to AD04, its lead investigational drug product for the treatment of Alcohol Use Disorder (AUD). The new warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the new warrants issued in the private placement and the shares of common stock underlying the new warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. About Adial Pharmaceuticals, Inc. Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions and related disorders. The Company's lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company's ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes (estimated to be approximately one-third of the AUD population) identified using the Company's companion diagnostic genetic test. ONWARD showed promising results in reducing drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at www.adial.com. Forward-Looking Statements This communication contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include without limitation, statements regarding the closing of the private placement, the satisfaction of the closing conditions of the private placement, and the use of net proceeds from the private placement as well as the potential of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, market and other conditions, our ability to pursue our regulatory strategy, our ability to maintain our Nasdaq listing, our ability to advance ongoing partnering discussions, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to retain our key employees or maintain our Nasdaq listing, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2022, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law. Investor Contact Crescendo Communications, LLCDavid Waldman / Alexandra SchiltTel: 212-671-1020Email: adil@crescendo-ir.com