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注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。近五年我国累计获批上市33款中成药，包括20款1类中药创新药、11款3类古代经典名方。本文基于摩熵咨询最新发布的《数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况》报告中的内容，筛选出其中最值得关注的3款重磅中药新药进行详细介绍。 01解郁除烦胶囊  以岭药业的解郁除烦胶囊于2021年12月获批上市，2022年纳入医保乙类目录，为国内首款治疗抑郁症的1.1类中药创新药。据摩熵医药全国医院销售（全终端）数据库显示，2023年我国抗抑郁中成药院内销售额达7.24亿元，同比增长约17%。组方源自汉代张仲景经方“半夏厚朴汤、栀子厚朴汤”化裁而成，具有解郁化痰，清热除烦的功效，适用于轻、中度抑郁症中医辨证属气郁痰阻、郁火内扰证患者。截图来源：摩熵咨询《数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况》报告临床试验有效性方面，在随机双盲、双模拟、多中心，样本量560例临床试验中，解郁除烦胶囊改善汉密尔顿抑郁量表评分优于安慰剂（P＜0.01），非劣于氟西汀（P＞0.05）；且显著改善汉密尔顿焦虑量表评分和中医证候总分，优于安慰剂和氟西汀（均P＜0.01）。数据来源：以岭药业公司官网，国家医保局，摩熵咨询整理02虎贞清风胶囊 一力制药研发的虎贞清风胶囊于2021年12月获批上市，2024年首次纳入医保乙类目录，是首个用于治疗急性痛风的中成药，属于国家1.1类中药创新药。截图来源：摩熵咨询《数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况》报告这款新药通过完成严格的上市前研究以验证临床有效性，包括药理药效学试验、毒性试验、Ⅱa期临床试验、Ⅱb期临床试验、Ⅲ期临床试验。虎贞清风胶囊临床优势显著，可明确用于急性痛风性关节炎，急性期控制症状疗效显著，且滋补肝肾兼顾治本，在心血管系统、肝肾功能、消化道溃疡、痛风石破溃等方面可能带给痛风患者更多获益。同时安全性佳，禁忌相对较少。数据来源：一力制药公司官网，国家医保局，摩熵咨询整理 03苓桂术甘颗粒苓桂术甘颗粒是国家药监局首个批准上市的按古代经典名方目录管理的中药复方制剂，属于中药3.1类新药，上市许可持有人为康缘药业。截图来源：摩熵咨询《数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况》报告苓桂术甘颗粒处方来源于汉·张仲景《金匮要略》苓桂术甘汤，已列入《古代经典名方目录（第一批）》。苓桂术甘汤为温化水湿的代表方，自古以来有较多医案证据作为支撑，为千古第一祛湿方，业内认可度较高。这款药物由康缘药业和上海中医药大学合作研发，于2022年12月获批上市，截止上市日康缘药业对苓桂术甘颗粒项目累计研发投入近1000万元。截图来源：摩熵咨询《数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况》报告END本文为原创文章，转载请留言获取授权《数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况》下期内容预告目录一、中药研发哪家强？中药企业研发实力榜单出炉二、4700亿大市场，注射用血塞通、安宫牛黄丸、阿胶三强争霸三、安宫牛黄丸狂卖近60亿元！盘点销售表现强势的8款中成药大品种近期将持续更新，敬请期待近期热门资源获取数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-2025042023H2-2024H1中国药品分析报告-2025042024年中国1类新药靶点白皮书-202503中国AI医疗健康企业创新发展百强榜单-202502解码护肤抗衰：消费偏好洞察与市场格局分析-2025022024年FDA批准上市的新药分析报告-2025012024年NMPA批准上市的新药分析报告-2025012024年医保谈判及市场分析报告-2025.012024年中国医疗健康投融资全景洞察报告-202501小分子化药白皮书（上）-2025012024医美注射材料市场发展分析报告-202412中国放射性药物产业白皮书-202410近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

AGOURA HILLS, Calif., April 16, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) ("Oncotelic", the "Company" or "We"), a developer of treatments for rare and orphan indications, including Parkinson's Disease, pancreatic ductal adenocarcinoma (“PDAC”), diffuse intrinsic pontine glioma (“DIPG”), and various other cancers, today announced its financial results for the fiscal year ended December 31, 2024 (“FY 2024”), as compared to the fiscal year ended December 31, 2023 (“FY 2023”). The financial results are based on the Annual Report on Form 10-K (“Form 10-K”) as filed with the Securities and Exchange Commission (“SEC”) on April 15, 2025. Highlights for FY 2024 and thereafter: 2024 has been a transformational year for us. We made great progress on multiple fronts and this momentum continues in 2025. We individually discuss each of these areas below: San Diego Facility Our joint venture (“JV”), GPM Biotechnology Limited, with Dragon Capital Overseas Limited has continued the development of its nanoparticle pipeline at its facility in San Diego (“Facility”) since late 2023 / early 2024. In late 2024, just over a year after breaking ground, the Facility became good manufacturing practices certified and was issued a Drug Manufacturing License by the State of California Department of Public Health and Food and Drug Branch. The Facility is planned to primarily manufacture our drug product, including the clinical trial materials, for the clinical programs for each of our compounds. Nanoparticle Platform At the Facility, the JV initially identified 5 compounds, including OT-101, for development as nanoparticles. Subsequently, the JV identified an additional compound, bringing the total to 5 new compounds, not including OT-101. Each of the nanoparticle compounds is designed as a next-generation anticancer agents. We believe that each of these new compounds can potentially lead to significant revenue and value for the JV, which in turn could lead to significant value to the Company due to our investment in the JV. Two of the 6 compounds are in late stages of manufacturing, and the Company plans to file INDs for both before the end of the year. Our proprietary nanoparticle platform enables the development of multiple therapeutic candidates, to address various oncology indications. Investigational New Drug Filing Platform with Shanghai Medicilon We recently announced that we entered into an agreement to utilize the proprietary rapid investigational new drug (“IND”) platform created and owned by Shanghai Medicilon Inc. (“Medicilon”) to file up to 20 new INDs. We, and the JV, plan to utilize it to file the 6 compounds identified utilizing the Medicilon IND platform, among and upto 20 total filings. OT-101 Clinical Program The primary candidate of our JV, OT-101, which has previously completed multiple clinical trials, is currently undergoing a Phase 3 trial in pancreatic cancer. OT-101 also completed a phase 1 combination trial with IL-2. This will allow us to pursue OT-101 in combination with various checkpoint inhibitors, such as PD-1 blockers. Artificial Intelligence Platform Our artificial intelligence (“AI”) team has played an increasingly important role in the development of the Company and the Facility. Our proprietary AI technology has been used by our scientists in writing research papers, development reports, and regulatory documents from the data gathered from our Facility and elsewhere. As announced in December 2024, we are leveraging our AI Platform, “PDAOAI”, to allow third party researchers and individuals to utilize our platform in their workflow. Unlike standard AI tools, PDAOAI is specifically designed for pharmaceutical regulatory processes and research documentation, streamlining workflows and potentially accelerating development timelines. Results of Operations Below is a presentation of our financial results comparing FY 2024 to FY 2023, and are based on our results published in our Form 10-K filed with the SEC on April 15, 2025. FY 2024 compared to FY 2023 Financial Results Overview ONCOTELIC THERAPEUTICS, INC. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF OPERATIONS For the Year Ended December 31, 2024 2023 Service Revenue $- $70,000 Total Revenue - 70,000 Operating expenses: Research and development $- $61,143 General and administrative 376,013 573,726 Goodwill impairment (See note 2 and 3) 3,200,000 6,083,146 Total operating expenses 3,576,013 6,718,015 Income/(Loss) from operations (3,576,013) (6,648,015)Other income (expense): Interest expense, net (857,723) (1,044,786)Reimbursement for expenses - related party 22,937 72,246 Change in fair value of investment in GMP Bio - 12,706 Change in fair value of derivative on debt (280,402) (225,074)Loss on debt conversion (88,258) (373,142)Total other income (expense) (1,203,446) (1,558,050)Net income (loss) before non-controlling interests (4,779,459) (8,206,065)Net loss attributable to non-controlling interests (255,527) (302,972)Net income (loss) attributable to Oncotelic Therapeutics, Inc. $(4,523,932) $(7,903,093) Basic net loss per share attributable to common stock $(0.01) $(0.02)Basic weighted average common stock outstanding 404,396,473 384,075,369 We incurred a lower net loss per basic share of $0.01 for the year ended December 31, 2024 as compared to net loss per basic share of $0.02 for the year ended December 31, 2023. We incurred a significantly lower net loss of approximately $3.4 million between December 31, 2024 and 2023, respectively. The lower net loss was primarily due to lower impairment of goodwill by approximately $2.9 million, lower general and administrative expenses of approximately $0.2 million and lower other expenses, including interest cost, or approximately $0.3 million. All operational costs associated with OT-101 and the nanoparticle platform are substantially covered by the JV, significantly reducing our direct financial burden till such time we make a determination to commence development of our own compounds. “Our JV is growing rapidly and is moving towards a potential initial public offering, the timing of which is under evaluation. The JV’s product portfolio has the potential to generate significant revenues and value for itself and, consequently, the Company and its shareholders due to our ownership in the JV. That has been the plan for the Company, since we entered into the JV. As reported in our Form 10-K, while we believe that the valuation of the JV has increased, we have opted to revise the fair value of our investment in the JV only upon a triggering event occurring, and justifying the revision to our fair value, such as, but not limited to, a financing, licensing, an IPO, or results of late stage clinical trials such as our Phase 3 pancreatic cancer trial”, said Amit Shah, CFO for Oncotelic. About Oncotelic Oncotelic (f/k/a Mateon Therapeutics, Inc.), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic has rare pediatric designation for Diffuse Intrinsic Pontine Glioma “DIPG” (through OT-101) through its 45% joint venture, melanoma (through CA4P), and Acute Myeloid Leukemia “AML” (through OXi 4503). Oncotelic also acquired PointR Data Inc. in November 2019. Oncotelic acquired AL-101, during the 4th quarter of 2021, for the intranasal delivery of apomorphine. We intend to develop AL-101 for the treatment of Parkinson Disease ("PD"). Over 60,000 new patients are being diagnosed with PD in the United States and currently there are over 1 million patients in the US and expected to increase to over 1.2 million by 2030. In addition, approximately 10 million suffer from this disease globally. https://www.parkinson.org/Understanding-Parkinsons/Statistics. AL-101 is also being developed for Erectile Dysfunction ("ED"). ED is the most prevalent male sexual disorder globally. The percentages of men affected by ED are as follows: 14.3-70% of men aged 60 years, 6.7-48% of men aged 70 years, and 38% of men aged 80 years (Geerkens MJM et al. (2019). Eur Urol Focus. pii: S2405-4569(19)30079-3). However, with the increasing administration of PDE5 inhibitors in clinical practice, it was found that approximately 30-35% of ED patients are treatment failures (McMahon CN et al. (2006). BMJ, 332: 589-92). AL-101 is designed to target treatment failure ED patients who do not respond to PDE5 inhibitors. Through similar mechanism of action, AL-101 is being developed for Female Sexual Dysfunction ("FSD"). Female sexual dysfunction is a prevalent problem, afflicting approximately 40% of women and there are few treatment options. FSD is more typical as women age and is a progressive and widespread condition. (Allahdadi, KJ et al. (2009) Cardiovascular & hematological agents in medicinal chemistry, 7(4), 260-269). There is no available drug for the treatment of FSD. In June 2019, the U.S. Food and Drug Administration approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder ("HSDD") in premenopausal women. This is the only available drug treatment. Vyleesi has essentially replaced the only other drug for HSDD - however, it has a long list of drug-drug interactions, including commonly used antidepressants, such as fluoxetine and sertraline. In addition, it has a black box warning regarding its use with alcohol, a combination that has been associated with hypotension and syncopal episodes. Therefore, there is an urgent need for effective therapy against FSD and HSDD. Oncotelic's Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”) that involve substantial risks and uncertainties. We generally identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “would,” “intend,” “target,” “aim,” “project,” “believe,” “estimate,” “predict,” “potential,” “seek,” “indicate,” or “continue” or the negative of these terms or other similar words, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements regarding our or our management’s expectations, hopes, beliefs, intentions or strategies regarding the future, such as our estimates regarding anticipated operating income or losses, future performance, future revenues and projected expense, including that to fund our clinical and other development programs; our liquidity and our expectations regarding our needs for and ability to raise additional capital; our ability to continue as a going concern; our ability to select and capitalize on commercially desirable product opportunities as a result of limited financial resources; our ability to manage our expenses effectively and raise the funds needed to continue our business; our ability to retain the services of our current or future executive officers, directors and principal consultants; the competitive nature of our industry and the possibility that our products or product candidates may become obsolete or may not generate revenues as expected or at all; our ability to obtain and maintain regulatory approval of our existing products and any future products we may develop; the development of and the process of commercializing AI/Blockchain and other technologies for supporting the development of OT- 101 and Artemisinin for COVID-19, OT-101, including development of OT-101, Artemisinin, OXi4503, CA4P and our 2021 in-licensing of apomorphine; the initiation, timing, progress and results of our preclinical and clinical trials, research and development programs; regulatory and legislative developments in the United States and foreign countries; the timing, costs and other limitations involved in obtaining regulatory approval for any product; the further preclinical or clinical development and commercialization of our product candidates; the entering into any corporate transactions to develop our products through partnerships, joint ventures or other corporate transactions; our ability to make a proposed initial public offering between us and our joint-venture partners for the joint venture, statements about future plans related to the operations of the JV, taking the JV into an initial public offering or the success thereof: building and the success of our nanoparticle platform and the related success of launching the platform; the expected valuation of the JV, and therefore a corresponding increase in the valuation of the Company, by virtue of it’s ownership in the JV; the success of the launch of Pet2DAO, a corporation with a DAO infrastructure, the success of Pet2DAO and the plans surrounding the pet and animal health, the ability for the Company to register the tokens of Pet2DAO, the actual filing of a registration statement and approval of the tokens as registrable securities with the Securities and Exchange Commission (“SEC”) through a registration statement, the ability of the tokens to be tradable or any value such tokens may have if they become tradable; our ability to obtain and maintain orphan drug exclusivity for some of our product candidates; the potential benefits of our product candidates over other therapies; our ability to enter into and maintain any collaboration with respect to product candidates; our ability to continue to develop or commercialize our products or product candidates in the event any license agreements in place with third parties expire or are terminated; the performance and conduct of third parties, including our third-party manufacturers and third party service providers used in our clinical trials; our ability to obtain and maintain intellectual property protection for our products and operate our business without infringing upon the intellectual property rights of others; the potential liability exposure related to our products and our insurance coverage for such exposure; our ability to form alliances with other third parties to develop the products in our pipeline through partnerships, joint ventures, mergers or acquisitions; the successful development of our sales and marketing capabilities; the size and growth of the potential markets for our products and our ability to serve those markets; the rate and degree of market acceptance of any future products; the volatility of the price of our common stock; the ability to achieve secondary trading of our stock in certain states; the dilutive effects of potential future equity issuances; our expectation that no dividends will be declared on our common stock in the foreseeable future; our ability to maintain an effective system of internal controls; the payment and reimbursement methods used by private or governmental third-party payers; our ability to retain adequate staffing levels; unfavorable global economic conditions; unfavorable global epidemic and pandemic conditions; a failure of our internal computer systems or those of our contractors and consultants; potential misconduct or other improper activities by our employees, contractors or consultants; the ability of our business continuity and disaster recovery plans to protect us in the event of a natural disaster; and other factors discussed elsewhere in this document or any document incorporated by reference herein or therein. Contact Information: For Oncotelic Therapeutics, Inc.:Investor Relationsir@oncotelic.com