Cycloserine

NRx has refiled its Abbreviated New Drug Application for KETAFREE™ (preservative free ketamine), received supportive correspondence from FDA, and expects Q2 2026 GDUFA date.HOPE Therapeutics is now operating three revenue-generating facilities in Florida and expects six or more by year-end providing neuroplastic drugs, transcranial magnetic stimulation, hyperbaric therapy, and digital therapeutics to treat suicidal depression and PTSD.NRx has secured operating capital anticipated to be sufficient for drug development operations through July 2026. The Company additionally expects to increase revenue from clinical operations.NRx received FDA grant of Fast Track Designation for NRX-100 in the treatment of suicidal ideation in patients with depression, including bipolar depression.New Real-World Data support the effect of D-cycloserine (NRX-101 active ingredient) in doubling the effectiveness of Transcranial Magnetic Stimulation (TMS). Company has expanded access program for NRX-101 in augmenting TMS in depression, suicidality, and PTSD. WILMINGTON, Del., Nov. 17, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals,” the “Company”), a clinical-stage biopharmaceutical company, today announced financial results for the quarter ended September 30, 2025, and provided a corporate update. “In 2025 we have advanced each of our corporate objectives and entered into revenue-generating activity for the first time. For NRX-100 in suicidal depression, we received an expanded Fast Track designation, opened an Expanded Access program and enhanced our regulatory package. Additionally, FDA granted our Suitability Petition for a single patient, preservative free ketamine strength and we have received validation that our ANDA filing is on track with no major deficiencies. In parallel, the Real World Data demonstrating a doubling of antidepressant and antisuicidal effect of Transcranial Magnetic Stimulation (TMS) when D-cycloserine is added creates a new and significant indication for NRX-101 that has potential for approval, if confirmed in an additional phase 3 trial. For HOPE, we continue to execute on building our delivery platform of three active facilities in Florida, with three more planned by year-end. Dr. Rebecca Cohen and LTC Charles Paul, RN (US Army, Ret.) are assembling a network of best-in-class interventional psychiatrists to meet the needs of people, including active duty military, first responders, and veterans, across Florida and beyond,” said Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals. Key Research and Development and Corporate ActivitiesNRX-100 (intravenous ketamine)NRx is pursuing two paths to market for NRX-100: a distinct innovative pathway via a New Drug Application (NDA) under FDA Fast Track designation to develop NRX-100 for suicidal ideation in depression, including bipolar depression, and a generic pathway via an Abbreviated New Drug Application (ANDA) to supply a preservative-free ketamine (KETAFREE™) into the existing ketamine market. Recent correspondence from the FDA suggests that the latter pathway is on track for a Q2 2026 GDUFA date. The current generic ketamine market is estimated at approximately $750 million, as previously disclosed. By contrast, the innovative ketamine-based product SPRAVATO® is expected to generate over $1.6 billion in 2025 sales, although its labeling states that effectiveness in preventing suicide or reducing suicidal ideation has not been demonstrated. This highlights a differentiated opportunity for NRX-100, specifically in suicidal ideation.A New Drug Application (“NDA”) for NRX-100 for suicidal depression, originally initiated during the fourth quarter of 2024, is expected to be completed in the fourth quarter 2025 with the addition of Real World Efficacy Data drawn from more than 60,000 patients treated for depression with intravenous ketamine compared to 6,000 patients treated with intranasal S-ketamine to be submitted as part of the NDA. An interim analysis drawn from the first 20,000 patients suggests that IV ketamine may have a more rapid onset of action and larger magnitude of effect than nasal S-ketamine. The Company has applied to receive a Commissioner’s National Priority Voucher (CNPV), which could significantly reduce review time. The Abbreviated New Drug Application (“ANDA”) for NRX-100 was filed, with Priority Review requested, during the third quarter of 2025. After meeting with the FDA in August 2025, the Company re-filed the ANDA, following FDA notification of approval of a Suitability Petition for NRx’s proposed strength of preservative-free ketamine, KETAFREE™. On November 6, 2025, the Company received a communication from FDA in which no significant deficiencies were identified in the revised filing. The Company has additionally submitted a Citizen Petition seeking to have benzethonium chloride, a toxic preservative, removed from all commercial presentations of ketamine. The Company has manufactured multiple commercial lots of NRX-100 and KETAFREE™ with ongoing stability data supporting a room temperature shelf life of three years. NRX-101: Oral Treatment for Suicidal Bipolar DepressionBipolar depression affects over seven million people in the US. Current treatment options carry the risk of suicide and akathisia, a side-effect of serotonin active antidepressants, which is closely related to suicide. People with bipolar depression and akathisia or suicidality are at imminent risk of self-harm. These patients need better treatment options urgently. An NDA filing for NRX-101 has been initiated with the submission of the Module 3 manufacturing file to publishing. The drug was previously awarded Breakthrough Therapy Designation, and accordingly the Company is requesting rolling review of the NDA. Breakthrough Therapy Designation is granted by the FDA to facilitate the development and expedite the review of drugs to treat serious conditions meet an unmet medical need and have demonstrated preliminary evidence of efficacy, as determined by the FDA. Recently published Real World Efficacy data provides confirmatory evidence from a prior randomized controlled trial that low-dose D-cycloserine (the active ingredient in NRX-101) more than doubles the anti-depressant and anti-suicidal effect of Transcranial Magnetic Stimulation. The company has more than 25,000 manufactured doses of NRX-101 at the appropriate strength on hand and has launched a nationwide expanded access program to enable physicians to access this medication at no charge to the patient under Expanded Access and Federal Right to Try laws. A confirmatory phase 3 trial of NRX-101 to augment the effects of TMS is planned for early 2026. The market estimate for this newly validated indication for NRX-101 is in excess of $1 Billion. HOPE Therapeutics: Interventional Psychiatry Clinic NetworkHOPE Therapeutics, Inc., is a medical care delivery organization providing cutting-edge interventional psychiatric treatment of the above conditions with neuroplastic drugs, such as ketamine, Spravato and NRX-101, neuromodulatory devices, such as Transcranial Magnetic Stimulation (“TMS”), hyperbaric therapy, digital therapeutics, and medication management. On September 8, 2025, HOPE initiated revenue-generation through its acquisition of Dura Medical, LLC (“Dura”) in Naples and Ft. Myers, Florida and subsequently added Cohen and Associates in Sarasota, FL to the HOPE Network. Dr. Rebecca Cohen has been appointed as HOPE’s Medical Director. Last week, HOPE was the first organization in Florida to launch one day TMS treatment for severe depression with the ONE-D protocol using the Ampa TMS device. The ONE-D protocol has been reported in the peer-reviewed literature to achieve 87% response and 72% remission from severe depression at 6 weeks following a single day of TMS treatment, combined with D-cycloserine. HOPE is in the process of adding three more facilities in 2025 and is in active discussion with numerous acquisition opportunities around the country. Financial Results for the Quarter Ended September 30, 2025 For the three months ended September 30, 2025, the Company reported a loss from operations of $4.0 million versus a loss from operations of $3.0 million for the comparable quarter in 2024. The difference was primarily attributable $800,000 of additional research and development expense to support our FDA initiatives for NRX-100 and NRX-101, including the previously discussed ANDA submission for preservative-free IV ketamine; and, $400,000 of additional general and administrative expense, which included our efforts to close, operate and identify clinic acquisition targets for HOPE. As of September 30, 2025, NRx Pharmaceuticals had approximately $7.1 million in cash and cash equivalents. Including approximately $3.1 million from a subscription receivable, for which the Company received the cash in early October, total cash as of September 30, 2025 would have been $10.3 million. For the third quarter ended September 30, 2025, the Company reported revenue for the first time in its history driven by the acquisition of Dura Medical, which closed September 8, 2025. While revenue of approximately $240,000 was relatively modest, it only reflects twenty-two days of the full quarter and a single clinic group. Management anticipates the ability to include results from the full period for Dura in future quarters; closing anticipated additional acquisitions; and organic growth of previously acquired clinics will drive meaningful revenue growth in the fourth quarter and through 2026. Transactions where we acquire a non-controlling interest are expected to improve our overall financial condition but not directly increase revenue. Finally, we remain in active discussions with several additional potential acquisition candidates, and while no assurances can be given that we will close any or all such opportunities, together they represent total revenue of more than $20 million on an annual basis. The Company believes that its current cash position will support operations at least through the second quarter of 2026, as well as provide sufficient capital to reach expected regulatory inflection points and complete potential additional select acquisition opportunities to expand the growing footprint of HOPE clinics. Detailed financials can be found in our recent Form 10-Q filing, available on our website, at https://ir.nrxpharma.com/sec-filings. Conference Call and Webcast DetailsA live webcast of the conference call will be available on the Company's website at 8:30am ET today, at NRx Events . An archive of the webcast will be available on the Company’s website for 30 days. Participants that are unable to join the webcast can access the conference call via telephone by dialing domestically 1-800-717-1738 or internationally +1-646-307-1865. About NRx Pharmaceuticals, Inc.NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has recently re-filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression. About HOPE Therapeutics, Inc.HOPE Therapeutics, Inc. (www.hopetherapeutics.com), a subsidiary of NRx Pharmaceuticals, is a healthcare delivery company that is building a best-in-class network of interventional psychiatry clinics to offer ketamine and other neuroplastic medications, transcranial magnetics stimulation (TMS), Hyperbaric Oxygen Therapy, and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy. HOPE is the first network in Florida to offer the AMPA One Day (ONE-D) treatment that combines TMS, physician-prescribed D-cycloserine, and lisdexamfetamine to achieve remission from treatment resistant depression. Notice Regarding Forward-Looking StatementsThe information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. The Company has reported regulatory milestones as they have been achieved but has not predicted the outcome of any future regulatory determination. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, including uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, and, among other things, liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, the Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise. For further information: Matthew DuffyChief Business Officer, NRx Pharmaceuticalsmduffy@nrxpharma.comBrian KorbInvestor Relations, ASTR Partners917-653-5122brian.korb@astrpartners.com PATIENT and PHYSICIAN INQUIRIES1-(833)-4HOPETMSwww.hopetherapeutics.com

1. 辰欣药业创新药研发概况 1.1 公司创新转型背景与战略定位 辰欣药业股份有限公司作为国内大输液领域的龙头企业，正处于从传统仿制药企业向创新驱动型综合医药集团转型的关键时期。公司成立于1970年，经过五十余年的发展，已成为一家集研发、生产、销售于一体的综合性制药企业。面对医药行业持续调整的大环境和加快培育新质生产力的新要求，辰欣药业坚定"没有科技创新就没有生命力"的发展战略，用技术的制高点来支撑品牌的生命力。 公司坚持仿制药、OTC外用药、创新药、特医食品四轮驱动战略，布局普药精制升级，持续聚焦高壁垒复杂制剂。从以仿制药为主向"仿创结合"迈进，在研国家一类创新药9项，两项进入Ⅲ期临床阶段，四项进入Ⅱ期临床阶段。2025年7月21日，辰欣药业新增"创新药"概念，标志着市场对其创新转型的认可 。 1.2 创新药研发管线整体布局 截至2025年7月30日，辰欣药业已有9款创新药进入不同临床阶段，形成了覆盖抗感染、肿瘤、自身免疫、代谢疾病等重大未满足临床需求领域的差异化管线矩阵 。 抗感染领域占据重要地位，包括抗耐药结核菌1类新药（WX081）、抗流感病毒1类新药（WXSH0208片）和抗真菌1类新药。其中，抗耐药结核菌新药已进入III期临床，有望成为国内首个针对耐药结核的国产创新药 。 肿瘤领域布局最为丰富，拥有4款创新药：双靶点抗肿瘤1类新药（WX390片，mTOR/PI3K抑制剂）、三靶点抗肿瘤1类新药、PARP抑制剂（WM2）以及另一个处于早期阶段的抗肿瘤药物。这些药物通过不同机制克服肿瘤异质性和耐药性 。 代谢疾病领域聚焦糖尿病治疗，口服GLP-1激动剂（TTP-273）作为全球首个口服GLP-1类药物，正在II期临床研究中 。 其他领域包括治疗自身免疫炎症1类新药和急性胰腺炎1类新药，均处于早期临床阶段 。 1.3 研发投入与创新能力建设 辰欣药业持续加大研发投入，2024年研发总投入3.43亿元，占营业收入比例为8.61% 。公司目标将研发投入占比提升至10%-15%，保持同行业上游水平的技术研发投入 。 公司拥有强大的研发平台体系，包括国家级企业技术中心、院士工作站、静脉营养大容量注射剂国家地方联合工程实验室、泰山学者药学特聘专家岗位、山东省抗生素工程技术研究中心、博士后科研工作站等科研创新平台。在济宁、北京、印度、天津、济南等地设有研发机构，形成了集约化研发体系 。 研发团队实力雄厚，现有研发人员600余人，70%以上为研究生以上学历，其中国家级高层次人才3人，省级以上高层次人才7人，高级职称人员80余人 。公司坚持自主创新与合作创新相结合，先后与中国药科大学、中科院上海药物研究所、军事医学科学院等30余家国内外优秀科研院所建立战略合作关系 。 2. 重点创新药研发进展分析 2.1 抗感染类创新药 2.1.1 抗耐药结核菌新药（WX081） 研发进展与临床设计 抗耐药结核菌1类新药（WX081，商品名舒达吡啶）是辰欣药业的核心创新药之一。该药物于2023年末启动III期临床试验，截至2025年7月仍在进行中，预计2025年完成III期临床并提交上市申请 。 III期临床试验设计为多中心、随机、开放、对照研究，在全国21家医院开展，目标入组450例患者，实际已入组15例。试验主要终点为治疗24周后舒达吡啶组和贝达喹啉组的痰培养阴转率，次要终点包括痰培养阴转时间等。 技术优势与差异化特征 WX081通过结合结核分枝杆菌ATP合成酶F0区域的质子通道，抑制质子泵从而阻碍ATP的合成，切断细菌能量供应，发挥抗菌及杀菌作用。与已上市的贝达喹啉具有相同的作用机制，但在安全性方面有显著改进。 临床前研究表明，WX081对结核病具有相当的疗效，但具有较低的心脏毒性和更有利的药代动力学特性 。与贝达喹啉相比，WX081的肝损伤风险降低了60%，这是其重要的差异化优势 。 市场前景评估 中国耐药性结核患者存量35万，每年新增7万例，市场需求巨大。目前国内尚无同类药物上市，WX081若成功将填补这一空白。根据测算，假设上市后定价年治疗费用1.5万元，峰值渗透率为20%存量患者+30%新增患者，销售峰值可达13.65亿元。 2.1.2 抗流感病毒新药（WXSH0208） 研发进展与临床设计 抗流感病毒1类新药（WXSH0208片）于2024年9月完成II期临床试验，2025年7月30日正式获得国家药监局III期临床批准通知书，即将启动III期临床 。2024年12月已启动III期临床试验 。 WXSH0208是一种口服小分子流感病毒RNA聚合酶PA亚基抑制剂，可阻断病毒RNA的转录和复制，抑制流感病毒的增殖 。临床拟用于甲型和乙型流感的治疗，对奥司他韦耐药毒株有效。 技术特点与竞争优势 WXSH0208针对流感病毒RNA聚合酶PA亚基的核酸内切酶，与罗氏的玛巴洛沙韦同靶点。在体内药效学研究中，WXSH0208在耐受性良好的剂量下，对乙流病毒的药效要优于或相当于上市的相关抑制剂药物，对甲流病毒的药效则相当。 作为RNA聚合酶抑制剂，WXSH0208能有效阻断病毒复制，对耐药毒株同样有效，生物利用度更优于同类药物 。目前国内同类产品仅罗氏玛巴洛沙韦片上市，若该药成功获批，将有望抢占千亿市场份额 。 临床进展更新 2025年2月，辰欣药业WXSH0208片药物Ⅲ期临床试验方案讨论会圆满召开，标志着WXSH0208项目正式进入临床III期研究阶段。即将开展的III期临床研究将在更大规模的样本上进行随机、双盲、安慰剂对照研究，进一步确证药物的安全性和有效性。 2.2 抗肿瘤类创新药 2.2.1 双靶点抗肿瘤新药（WX390） 研发进展与临床设计 双靶点抗肿瘤1类新药（WX390片）是一种新型口服小分子1类化药，为针对pan-PI3K和mTOR的高效PI3K-mTOR双靶点抑制剂。该药物于2023年末进入II期临床，2025年7月仍在进行中 。 WX390通过同时抑制PI3K/mTOR信号通路中两个重要靶点，从而抑制癌细胞的生长、存活、增殖和迁移，达到抑制肿瘤作用。临床研究采用每日一次1.1mg口服给药，最长治疗周期48周 。 技术创新与临床优势 与单一靶点小分子抑制剂相比，WX390具有剂量小、效价高、不易产生耐药性等特点 。该药物既能抑制细胞增殖也能促进细胞凋亡，能更加有效地抑制PI3K信号通路 。 临床前研究显示，WX390对依维莫司耐药肿瘤仍有效，水溶性优于辉瑞同靶点药物PF05212384 。在II期临床研究中，单臂试验客观缓解率（ORR）达42%，显著优于现有疗法的28%。 适应症布局 WX390的适应症包括晚期乳腺癌、结直肠癌等实体瘤 。2023年6月，一项多中心、开放、单臂Ⅱ期临床研究启动，旨在评估WX390单药治疗妇科肿瘤（卵巢癌、子宫内膜癌、宫颈鳞癌）的有效性与安全性，目标入组30例患者 。 2.2.2 三靶点抗肿瘤新药 三靶点抗肿瘤1类新药于2023年末进入II期临床，2025年7月仍处于临床阶段 。该药物通过同时阻断多个信号通路克服肿瘤异质性，靶点设计覆盖肿瘤多通路抑制 。 虽然具体靶点未公开，但根据临床前研究，该药物可能针对EGFR/HER2/HER3等多个靶点，通过多靶点协同作用提高疗效 。II期临床试验正在进行中，预计2025年披露初步数据 。 2.2.3 PARP抑制剂（WM2） PARP抑制剂（WM2）于2025年获批临床，目前处于I期阶段 。该药物与中科院合作开发，用于BRCA突变肿瘤的治疗。 WM2通过抑制PARP酶活性，阻断DNA修复通路，导致肿瘤细胞死亡 。在BRCA突变的肿瘤细胞中，由于同源重组修复缺陷，PARP抑制剂可产生合成致死效应，达到精准治疗的目的 。 2.3 代谢疾病类创新药 2.3.1 口服GLP-1激动剂（TTP-273） 研发进展与临床设计 口服GLP-1激动剂（TTP-273）于2024年进入II期临床，目前仍在进行中 。该药物是全球首个口服GLP-1类药物，旨在解决注射剂的依从性问题 。 TTP-273是一种口服小分子非肽GLP-1受体激动剂，可用于治疗2型糖尿病，与目前已上市GLP-1注射药物具有相当的治疗效果，同时显现出减少胃肠道不良反应及提高患者依从性的潜力 。 技术突破与创新特点 TTP-273采用胃滞留缓释技术，生物利用度达65%，猴模型减重效果媲美注射剂。该药物通过葡萄糖依赖方式，增加胰岛素的生物合成和分泌，抑制胰高血糖素的分泌，抑制食欲及摄食，延缓胃内容物排空等，有利于降低餐后血糖并使血糖维持稳态 。 临床数据与前景分析 根据美国vTv Therapeutics公司的研究，TTP-273在IIb期临床研究中显示对降低糖尿病患者的糖化血红蛋白效果明显，且耐受性良好 。华东医药于2017年从vTv引进了TTP-273在16个国家和地区的开发、生产及商业化独家授权许可 。 中国GLP-1药物市场正经历爆发式增长，2023年规模达87.38亿元 。TTP-273作为口服剂型，若研发成功将颠覆千亿减肥药市场，峰值销售预计15亿元。 2.4 其他创新药研发进展 治疗自身免疫炎症1类新药 治疗自身免疫炎症1类新药于2024年完成I期临床，2025年启动II期临床试验 。该药物主要用于治疗活动性溃疡性结肠炎等自身免疫性疾病。 2024年8月7日，辰欣药业自主研发的化学小分子药物WXSH0176片收到组长单位中山大学附属第六医院医学伦理委员会临床研究项目审查批件，同意开展治疗活动性溃疡性结肠炎患者的Ⅱ期临床试验。 抗真菌1类新药 抗真菌1类新药于2024年完成I期临床，2025年启动II期临床 。该药物靶向Gwt1，用于外阴阴道念珠菌病（VVC）的治疗，全球进度第二 。 2025年上半年已完成II期入组，有望成为治疗复发性外阴阴道念珠菌病的新选择 。目前中国妇科抗真菌用药市场规模约为38.6亿元，其中外阴阴道念珠菌病治疗药物占比约35%，年度销售额约18.5亿元 。 急性胰腺炎1类新药 急性胰腺炎1类新药的人用适应症已完成I期临床研究，试验数据充分验证了其良好的安全性与耐受性。该药物即将步入II期临床试验阶段，旨在进一步评估其在目标患者群体中的疗效与安全性。 值得注意的是，该项目同时启动了兽药研发，合作开发的HP-2201预计2026年上市，市场前景广阔。2024年9月，辰欣药业与重庆汉佩生物达成战略合作，共同探索宠物急性胰腺炎治疗新路径。 3. 创新药研发能力与策略分析 3.1 研发体系建设与资源配置 辰欣药业建立了完善的研发体系，形成了"四大生产基地、五大工业园区"的布局，研发投入占比约10%，年研发基金近4亿元 。公司研发模式坚持自主创新与合作创新相结合，在印度、天津、济南设立的研发子公司全面运行，药物研究院承担科技成果在内部转化的重要任务 。 公司拥有289项专利，其中PCT专利19项，核心化合物如WX081、WX390等已申请PCT国际专利，构建了全球知识产权壁垒 。2025年8月，公司新获得"一种高纯度和高收率的苄氧吡啶类化合物的制备方法"和"氨基吡啶类化合物及其应用"等多项发明专利授权 。 3.2 技术平台与创新机制 辰欣药业依托国家企业技术中心和静脉营养大容量注射剂国家地方联合工程实验室两大国家级创新平台，配备行业内全国首批获得CNAS实验室认可的分析检测中心 。公司还拥有省内首家特医食品领域工程研究中心，形成了完整的研发创新体系 。 在创新机制方面，公司通过产学研合作和专利布局构建技术壁垒，加速研发成果转化。与中科院合作开发PARP抑制剂WM2等项目，通过技术入股分担研发成本 。同时，公司瞄准产业前沿，强化关键核心技术攻关，加快推进现有10个国家一类创新药项目 。 3.3 产学研合作模式与外部资源整合 辰欣药业高度重视产学研合作，先后与美国佐治亚州立大学、英国利物浦大学、北京大学、军事医学科学院、中国药科大学、山东大学等30余家国内外优秀科研院所开展科研合作 。 公司与中国药科大学的合作尤为深入，双方本着优势互补、平等互利和长期合作的原则签订协议书，联合共建"药物制剂研究与产业化"实验室 。2024年11月，中国药科大学工学院副院长曹崇江一行访问辰欣药业，双方围绕慢病精准营养、特定人群营养代谢规律等方面的科研合作与人才培养进行了深入交流 。 在国际合作方面，公司与美国佐治亚州立大学、英国利物浦大学、以色列的研发公司建立了密切的合作关系，保障前沿药物研发的技术先进性 。同时，公司聘任国际技术团队，负责向欧美等发达国家申报ANDA制剂项目，并合作开发系列产品，为打开国际市场积蓄力量 。 3.4 研发策略特点与差异化定位 辰欣药业的创新药研发策略具有鲜明的差异化特点。首先是靶点差异化选择，公司避开红海领域如PD-1，聚焦耐药感染、实体瘤多靶点抑制等未满足需求。例如，WX390针对mTOR/PI3K双靶点，而辉瑞同类药仍停留静脉剂型。 其次是治疗领域聚焦，公司围绕耐药性感染、实体瘤、自身免疫疾病、代谢疾病等重大未满足临床需求领域布局，形成差异化管线矩阵 。特别是在抗感染领域，公司同时布局了抗结核、抗流感和抗真菌三个方向，形成了完整的产品线。 第三是技术路径创新，如口服GLP-1激动剂TTP-273采用小分子药物研发平台，解决了传统GLP-1药物需要注射的痛点，有望成为全球首个口服GLP-1类药物 。 4. 市场竞争格局与商业化前景 4.1 各治疗领域竞争态势分析 抗感染领域竞争格局 在耐药结核治疗领域，目前全球仅有贝达喹啉和德拉马尼两个新药上市。中国市场方面，贝达喹啉仿制药于2022年通过一致性评价后，迅速覆盖全国28个省级采购市场，2024年前三季度销售额达3.99亿元，销售金额占比达22.72%，超越了利福平、环丝氨酸和异烟肼位居第1 。 在流感治疗领域，奥司他韦占据绝对主导地位，2024年市场份额达86.48%，销售额占我国抗流感药物总销售额的74.49% 。玛巴洛沙韦作为新一代流感药物，2024年上半年全球销售额为6800万瑞士法郎，其中中国市场高达5.1亿人民币，占比93% 。 肿瘤领域竞争格局 中国抗肿瘤靶向药物市场规模2024年已接近1850亿元，预计2025年将突破2100亿元 。在PARP抑制剂细分市场，奥拉帕利占据主导地位，2024年市场份额约为35-40%，尼拉帕利市场份额约为30% 。 代谢疾病领域竞争格局 GLP-1受体激动剂市场正经历爆发式增长，全球市场规模2024年达520.8亿美元，预计2032年将达1866.4亿美元 。中国市场2024年规模105亿元，司美格鲁肽注射液以超30亿元的销售额高居2024上半年GLP-1受体激动剂产品首位 。 4.2 辰欣药业创新药的竞争优势 辰欣药业的创新药在多个方面具有竞争优势： 技术优势明显。WX081相比贝达喹啉肝损伤风险降低60%，安全性更优 ；WX390的口服生物利用度优于辉瑞同类药PF05212384 ；TTP-273作为全球首个口服GLP-1类药物，具有独特的剂型优势 。 市场定位精准。公司聚焦未满足的临床需求，如耐药结核、奥司他韦耐药流感毒株、口服GLP-1制剂等，避开了激烈的红海竞争 。 成本优势突出。作为国内企业，辰欣药业在生产成本和医保谈判方面具有优势，有望提供更具性价比的治疗方案。 4.3 商业化路径与市场准入策略 辰欣药业创新药的商业化路径清晰，主要通过以下策略实现市场准入： 医保快速准入。根据2025年新版国家医保药品目录，新增的91种药品中有38种为"全球新"的创新药物，医保谈判规则进一步完善，为创新药进入目录和患者提供便利 。若WX081等新品上市，可通过医保谈判快速纳入报销目录，借助辰欣在感染领域的渠道优势覆盖全国结核病防治机构 。 医院渠道优势。辰欣药业在特医食品领域已与全国二三百家医院达成合作，覆盖了全国29个省、自治区、直辖市，部分区域已下沉至县级医院 。这种医院渠道优势可复制到创新药的商业化中。 差异化定价策略。针对不同产品采用差异化定价策略，如WX081作为填补国内空白的产品，可参考贝达喹啉的定价水平；TTP-273作为口服剂型，可在保证疗效的前提下提供更有竞争力的价格。 4.4 创新药价值评估与业绩贡献预测 基于各创新药的市场潜力和研发进展，辰欣药业创新药管线具有巨大的商业价值。根据市场分析和公司披露信息，主要创新药的峰值销售预测如下： 产品名称 适应症 临床阶段 峰值销售额预测 预测依据 WX081 耐药结核病 III期 10-13.65亿元 填补国内空白，患者存量35万 WXSH0208 流感 III期 5-15亿元 针对耐药毒株，市场容量大 WX390 实体瘤 II期 8-20亿元 双靶点优势，克服耐药性 TTP-273 糖尿病/肥胖 II期 15亿元 全球首个口服GLP-1 三靶点抗肿瘤药 实体瘤 II期 待评估 多靶点协同，克服异质性 PARP抑制剂(WM2) BRCA突变肿瘤 I期 待评估 精准治疗，市场前景良好 根据SOTP估值模型，辰欣药业创新药管线合计估值贡献可达414亿元，对应2025年动态PE约40倍。而当前公司市值仅约105亿元（截至2025年10月23日），若管线顺利推进，估值修复空间巨大。 从业绩贡献时间节点看，2025-2026年将是关键期：WX081预计2025年完成III期临床并提交上市申请，2026年有望获批上市；WXSH0208正在进行III期临床，预计2026-2027年获批；其他II期和I期药物将在2027-2030年陆续进入收获期。 5. 风险因素与发展展望 5.1 研发风险评估 辰欣药业创新药研发面临多重风险： 临床试验失败风险是首要风险。创新药研发周期长、投入高、风险大，特别是III期临床试验可能因疗效或安全性问题终止。例如，华东医药的TTP-273项目就曾因安全性问题中止。 技术竞争加剧风险不容忽视。在抗流感领域，众生药业的ZSP1273、健康元的TG-1000等竞品已进入后期临床，辰欣药业需要依靠更短的症状缓解时间等差异化优势突围。 监管政策变化风险需要关注。医保控价可能压缩创新药利润空间，如WX081上市后可能面临谈判降价压力 。同时，药品审评审批政策的变化也可能影响研发进度。 5.2 市场风险与应对措施 市场竞争风险日益严峻。在GLP-1领域，诺和诺德、礼来等国际巨头占据主导地位，国内也有多家企业在研发口服GLP-1类药物 。辰欣药业需要加快TTP-273的研发进度，确保先发优势。 医保谈判压力持续存在。2025年新版医保目录虽然增加了创新药纳入数量，但谈判降价幅度可能较大。公司需要通过成本控制和差异化优势来应对价格压力。 商业化能力考验不容忽视。从研发到商业化是一个复杂的过程，需要强大的销售团队、医院渠道和市场推广能力。辰欣药业需要在这些方面加强建设。 5.3 未来发展机遇 尽管面临诸多挑战，辰欣药业创新药研发也迎来重大机遇： 政策支持力度加大。2024年《政府工作报告》首次将"创新药"列为新兴产业关键环节和新质生产力重要组成部分。2025年新增商保创新药目录，为暂时无法纳入基本医保但创新程度高的药物提供了新的市场准入路径 。 市场需求快速增长。人口老龄化、疾病谱变化和消费升级推动创新药需求快速增长。特别是在耐药感染、肿瘤、糖尿病等领域，未满足的临床需求巨大。 技术平台日趋成熟。经过多年积累，辰欣药业已建立起完善的研发体系和技术平台，具备了持续创新的能力。特别是在口服制剂、多靶点药物等领域形成了技术优势。 5.4 发展战略建议 基于以上分析，对辰欣药业创新药发展提出以下战略建议： 加快重点产品研发进度。优先推进WX081和WXSH0208的III期临床，确保2025-2026年获批上市，抢占市场先机。同时，加快TTP-273的II期临床，力争成为全球首个口服GLP-1上市药物。 强化差异化竞争策略。继续聚焦耐药感染、多靶点肿瘤治疗、口服制剂等差异化领域，避免与国际巨头正面竞争。特别是在口服GLP-1、抗耐药结核等具有先发优势的领域，要加大投入，确保技术领先。 完善商业化能力建设。建立专业的创新药销售团队，加强与三甲医院、专科医院的合作。同时，积极布局院外市场，包括DTP药房、互联网医疗等新渠道。 深化国际合作。考虑将部分创新药的海外权益授权给国际合作伙伴，加快国际化进程。特别是在欧美市场，可以通过合作快速实现商业化。 加强风险管控。建立完善的临床试验风险管理体系，加强与监管部门的沟通，确保研发合规。同时，通过保险、合作等方式分散研发风险。 持续加大研发投入。将研发投入占比提升至12-15%，与国际接轨。重点投向具有自主知识产权和差异化优势的项目，构建可持续的创新能力。 总体而言，辰欣药业正处于创新转型的关键期，9款创新药进入临床阶段标志着公司已具备了一定的创新实力。在政策支持、市场需求和技术进步的多重驱动下，公司有望在2025-2027年迎来创新药收获期，实现从传统制药企业向创新驱动型医药集团的华丽转身。但同时也要清醒认识到创新药研发的高风险特征，通过科学的管理和持续的投入，才能最终实现创新转型的成功。