Doxorubicin Hydrochloride

2024，海正扭亏了，并且净利润超过了过去十年的任何一年。可以说，海正需要一次重估。 资深分析师：尧   今 最美编审：苏   叶 海正人始终希望重回巅峰。 2023年10月，海正药业迎来新总裁肖卫红，他也曾算海正的一份子。希望在海正人心中慢慢积累。第二年，肖卫红继续履新海正药业董事长，他喊出，“让海正再次伟大”！ 数年的变革和刷新，海正药业终于迎来好消息。 2024年业绩预喜：预计这一年将实现净利润5.7亿-6.3亿元，与上年比实现扭亏。并且，净利润超过了过去十年的任何一年。 在外界环境持续恶化的情况下，这一表现特别可圈可点，海正值得一次重估。 一方面，这家老牌药企有着中国医药崛起的历史，曾经比恒瑞还风光，第一个把中国原料药卖到海外并且独创一种模式；另一方面，从“大象”起舞到式微时刻，海正从沉重的教训中惊醒，自救-失败-自救，这种经历在中国也是稀缺的。 可海正真的翻身了吗？该怎么重估海正？CM10医药研究中心将从行业稀缺值、财务健康度、业务健康度以及综合建议等多个方面，来一一回答。 >>>欢迎进入E药资本界🔍「2024年报选题共创季」，如果您公司曾经深处低谷，现在正走出阴霾，需要价值重估，欢迎后台联系主理人，参加《重估》系列选题，让中国医药行业多一抹亮眼的绿！ 从辉煌到低谷 ❤️关注我，不迷路 产业里的医药老炮们对海正药业都不陌生，这家藏于台州的老牌药企，有着近70年历史。前身为海门制药厂，于2000年在上交所成功上市，曾一度引领时代。 即便现在，人们回顾海正的成败论时，也总会拿他和制药一哥恒瑞医药比较。 恒瑞的前身是1970年成立的连云港制药厂，两者均起家于中国医药产业崛起的关键城市，不仅是业务和起点相似，更是同年登陆资本市场。不过，后来的走向云泥之别。 早年前的海正，可以说是风光无两，比起恒瑞有过之而无不及。这一辉煌离不开一位关键先生——白骅。一个伟大的企业必然有一个伟大的企业家，就像华为有任正非，恒瑞有孙飘扬。 在他的执掌下，海正药业先后购入克念菌素、阿霉素、阿佛菌素等技术，推进抗生素产业化。尤其是阿佛菌素，成为海正药业史上首个利润过亿的单品种。凭借该款药物发力，甚至在国际兽药市场的市占率一度达到40%以上。　 更重要的是，一系列深远的改革和市场拓展策略，使得“海正模式”名声大噪。 回过头再看，其中最正确的决策之一，是历经数年、坚定推进当时看似吃力不讨好但具有前瞻性的FDA认证。据公开资料显示，海正药业的妥布霉素和阿霉素分别在1992年和1995年获得了美国FDA的认证，成为国内最早通过该认证、成功打入欧美高端市场的企业之一。到了1998年，海正药业投产的阿奇霉素更是通过合作模式，成为了首个进入欧洲市场的自主品牌。 自2000年上市后，海正的营收规模一路攀升，到2014年突破了百亿元大关，而同期的恒瑞还只有70多亿。有人曾赞誉说，十年前的海正药业是国内医药行业的“黄埔军校”。 然而，“大象”式微难以察觉，到问题出现时已经晚了。自2012年起，海正的增速已有所放缓。 变化背后，既有外部的催化，也有内部的积弊。 从重创抗生素市场的最严“限抗令”实施，到FDA、欧盟对海正原料药的禁入，再加上合资公司海正辉瑞后期合作的不利，一系列事件，都对海正药业造成了沉重的打击。 一时间海正急转直下。2015年，收入利润大幅下滑；第二年利润端更是首次陷入亏损；到2018年，海正的负债总额达到145亿元，负债率达66.24%，持续走高。 彼时正是中国创新药的激荡之年，可曾经的先锋海正却深陷水深火热。就在这年，海正又面临着灵魂人物白骅的退休，一时间信心跌至谷底。 与之相反，恒瑞却在此期间扶摇直上，2019年突破200亿元，纵使近些年转型承压，但制药一哥地位却近乎无人撼动。 如今如果从市值看，海正105亿，恒瑞2800亿，满是唏嘘和沉默。 自救：昙花一现 ❤️关注我，不迷路 曾经辉煌过的，怎会甘心一直处于低谷。如何重回巅峰，这几乎成为了海正药业近年来的核心命题与挑战。 面临此前数年积弊，海正药业更需直面改革。自2018年起,这家老牌药企终于明确了改革方向，在新的掌舵人蒋国平上任后，提出了“聚焦、瘦身、优化”的战略，开始大量处置闲置资产，剥离非核心业务，也开启了诸多资本动作。 海正药业主要干了几件事。一是厘清资产，梳理管线和产能，优化布局；二是明确战略并优化内控管理；三是降本增效，对工艺进行优化，欧盟整改。 •2019年，海正药业秉持瘦身举措：先后转让导明医药、海正博锐的股权；同时将上海、北京、台州等地的多处房产或厂房挂牌转让。同年引进战投，改革完善用人机制，梳理管线，积极拓展对外业务。 •2020年，海正药业重点推进瀚晖制药的资产重组业务，同时积极推进欧盟整改。 •2022年，海正药业控股子公司海正动保、甦力康完成内部重组，瀚晖制药与海晟药业内部重组，原料药生产欧盟整改取得实质性进展，一期工程验收合格。 与此同时，海正加速了从原料药向制剂业务的转型升级，旗下瀚晖制药的销售规模已经超过了同类的CSO平台；另外，海正药业也开始布局了海正动保等新业务。 …… 经过几年阵痛期，随着业务结构逐渐清晰，一切有了初步成效。 而今，其核心聚焦原料药、制剂、动保等业务。其中瀚晖制药通过整合海晟药业，慢病治疗管线补强，瀚晖制药核心业务包含抗感染、呼吸、肿瘤、慢病等领域；浙江省医药海正药业负责药品批发、兽药经营的经销工作，在售产品3000个，纯销业务覆盖浙江全省；海正杭州和海正南通是海正药业原料药业务的核心；海正动保是海正药业动保业务的核心主体。 业绩有了短暂的好转。2019年，海正药业扭亏为盈，2020年归母净利润同比大增348.25%。 然而复苏昙花一现。到2022年，海正已经不增长了，甚至营收开始下滑，2023年更是掩不住地同比下降13.82%，至103.73亿元。回到十年前水平。 当巨轮沉没时，如果不是创客，没人会愿意留在船上。2023年，海正药业董事长蒋国平、副董事长兼高级副总裁陈晓华双双辞职，期间还有财务总监等高管也都离开。 海正药业还能救得了吗？ 再打翻身仗 ❤️关注我，不迷路 海正人，真的希望能打起一场漂亮的翻身仗。 这时，又迎来了一位关键先生：2023年，曾任职海正辉瑞CEO的肖卫红获聘成为海正总裁，后在2024年10月履新董事长。 老将回归，再次拉开深化改革的序幕，但海正能否打赢这场翻身仗？这备受外界关注。 当前，肖卫红带领的海正药业正以前所未有的决心押注未来。然而，仅仅喊口号是远远不够的，更需要付诸实际行动。在过去的一年里，海正药业大刀阔斧的内部改革，解决了许多遗留问题，还成功出清了低效部分，调整了销售架构、营销模式、渠道布局，并进行了库存优化与提速降本工作。 无论干什么，都得把自身优势想明白。这家成立近70年的国企，正往多元化战略方向发展。海正药业确定以人用药为核心，医美大健康和动保为两翼的研发战略，打造“大海正”的集团品牌。具体来说分五步走： 一、巩固既有优势。 原料药——海正药业的看家之宝，中国原料药出海最早吃螃蟹的企业之一。自1992年首次通过美国FDA审计起，海正药业积累了30多年在全球70多个国家和地区的中高端原料药市场的资源网络。  尽管现在原料药业务很卷，利润也越来越薄，但海正药业凭借国内外已积累的口碑和工业基础支撑，在这一基础上，正在做优化，恢复老客户，开发新客户，规划未来原料药市场，提前做研发注册布局，让原料药重新成为海正的一条腿。 二、子公司分工明确，发挥各自最大的优势。 瀚晖制药前身即“海正辉瑞”，是国内唯一成功的原研药地产化案例，凭借其丰富的产品线、卓越的销售能力（尤其在抗感染和心血管领域表现突出）以及强大的产品力，瀚晖制药归母净利润连续多年高增长，从 2016 年的 3.5 亿元增长到 2022 年的8.4亿元。 其中辉瑞原研药产品力强市占率稳定，目前多达一、玫满、甲强龙等产品批次性地产化，未来有望贡献稳定现金流。新品方面，自研降脂产品海博麦布市场空间和格局良好，且进入医保目录未来放量可期，引进产品奥马环素、西格列他钠、“三润”系列等产品，由此被视为依托海正药业原有CSO业务优势有望实现快速增长。 创新药研发现阶段将资源聚焦在心血管、代谢等领域，欲踏踏实实做好创新药精准布局。 早在2021年6月，海正药业自主研发的创新药海博麦布片获批上市，是国内心血管领域近年唯一获批的1类新药，目前国内获批的胆固醇吸收抑制剂除依折麦布及其复方制剂外，仅有海正药业的海博麦布片。海博麦布因安全性更高、更适合中国人群，上市后销售额迅速增长，2022年院内销售额突破2亿元。据西部证券预测，随着治疗渗透率的提升，海博麦布峰值销售或近20亿元。考虑到我国血脂异常患病率高而治疗率低，若8%的患者使用胆固醇吸收抑制剂，海博麦布在市场的35%份额下，预计峰值销售可达19.54亿元。 三是，以新姿态去做动保业务。 海正动保主要从事动保业务，从事兽药研发、生产及销售，海正药业持股 66.34%。 这是另一大关键路径。海正药业专注动保其实已有20多年，成为国内宠物药第一品牌，其业务布局猪、反刍、宠物、疫苗四大领域，依托行业高景气度，海乐妙成为首个销售额突破1亿元的国产驱虫药，莫爱佳成为海正药业历史上销售最快破千万的单品（猫用体内外驱虫药以外资品牌为主，前五名中仅海正动保的莫爱佳为国产驱虫药）。自2019年以来，海正动保营业收入保持高速增长，2021年实现营业收入4.53亿元，同比增长28.8%，三年收入复合增速为52.66%。 四是开拓新兴业务，如依托现有工业基础以及合成生物学，迅速以原料药形式进入到大健康、医美等领域。 海正公司，一直深耕于发酵领域和生物制造领域，现已成功从生物制造技术平台升级为合成生物学平台。2024年12月28日，海正药业宣布海正药业将投入超1.7亿元的总投资，建成先进的专业化合成生物学产品柔性生产线。 五是，通过更轻量的运作做生物创新。 博锐生物是海正药业孵化的生物创新药企，聚焦免疫领域，具有20+主要在研产品，其中10+已进入临床和7个已商业化上市。从已上市产品品种来看，既有大单品的生物类似药，帮助快速打开自免、肿瘤的生物药市场，后续或可为自主研发的创新产品上市放量打下基础。 一切布局，似乎正在陆续开花结果的阶段。 参考资料： 西部证券《海正药业 首次覆盖报告：资产重估、困境反转，盈利能力稳步提升》 德邦证券《海正药业-经营效率+盈利能力持续改善，老牌药企焕发新机》 “  任何伟大的变革都是痛苦的。我们已经见证了，诸多仿制药企走向创新药企历经的黑暗与迷茫岁月。我们已经看见了，一些蜕变，和新价值的诞生。E药经理人旗下CM10医药研究中心致力于上市公司的价值发现、挖掘与诊断。”  喜欢我们文章的朋友点个“在看”和“赞”吧，不然微信推送规则改变，有可能每天都会错过我们哦~ 免责声明 “汇聚南药”公众号所转载文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请在留言栏及时告知，我们会在24小时内删除相关信息。 信息来源：原创 CM10医药研究中心 E药资本界 往期推荐 本平台不对转载文章的观点负责，文章所包含内容的准确性、可靠性或完整性提供任何明示暗示的保证。

RAHWAY, N.J.--( BUSINESS WIRE )--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of waveLINE-010, a pivotal Phase 3 clinical trial evaluating zilovertamab vedotin in combination with rituximab plus cyclophosphamide, doxorubicin and prednisone (R-CHP) compared to rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) alone, for the treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Zilovertamab vedotin is Merck’s investigational antibody-drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1). Global recruitment of the waveLINE-010 trial has begun, with patients now enrolling. “ Following the encouraging results observed in the Phase 2 waveLINE-007 trial, we look forward to evaluating the potential clinical benefits of a combination regimen with zilovertamab vedotin in patients with diffuse large B-cell lymphoma compared to the current standard treatment,” said Dr. Gregory Lubiniecki, vice president, oncology clinical research, Merck Research Laboratories. “ ADCs have shown promise as an important modality in the treatment of different cancer types, and the initiation of this Phase 3 waveLINE clinical trial demonstrates our commitment to researching zilovertamab vedotin to help address unmet needs for patients with this aggressive and most common form of non-Hodgkin lymphoma.” WaveLINE-010 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT06717347 ), which is enrolling an estimated 1,046 patients globally. The primary endpoint is progression-free survival (PFS), and secondary endpoints include complete response (CR) rate at the end of the treatment, overall survival, event-free survival, duration of CR and safety. Zilovertamab vedotin is currently being evaluated in the Phase 2/3 waveLINE-003 dose confirmation and expansion trial ( NCT05139017 ) for the treatment of relapsed or refractory DLBCL and in the Phase 2 waveLINE-007 trial ( NCT05406401 ) in combination with R-CHP in patients with previously untreated DLBCL. Merck recently presented data from this trial for the first time at the 66 th American Society of Hematology Annual Meeting and Exposition in December 2024. About diffuse large B-cell lymphoma Lymphoma is cancer beginning in the lymphatic system – the network of organs, vessels and tissues that protects the body from infection. There are many subtypes of lymphoma, which is often categorized into two main types – Hodgkin lymphoma and non-Hodgkin lymphoma (NHL). Diffuse large B-cell lymphoma, the most common form of NHL, is derived from white blood cells that grow rapidly and uncontrollably, enlarging the lymph nodes and often migrating to other parts of the body. DLBCL accounts for approximately 25-30% of all NHLs worldwide. In the U.S., it is estimated that approximately 25,000 patients are diagnosed with DLBCL each year. The five-year relative survival rate for DLBCL is 60-70%. About zilovertamab vedotin (MK-2140) Zilovertamab vedotin is an investigational ADC that targets ROR1. ROR1 is a transmembrane protein that is overexpressed in multiple hematologic malignancies. Merck is committed to research with zilovertamab vedotin across B-cell malignancies and is establishing a robust program of clinical trials under the name waveLINE. The waveLINE program includes a Phase 2/3 study in patients with relapsed or refractory DLBCL (waveLINE-003, NCT05139017 ) and a Phase 2 study in patients with previously untreated DLBCL (waveLINE-007, NCT05406401 ). About Merck in hematology Merck is committed to advancing innovation and care for people with hematologic neoplasms and malignancies. Building on its leadership in oncology, the company has a broad clinical development program that evaluates novel mechanisms of action to address longstanding unmet needs for patients with hematologic disorders. Among Merck’s research efforts are studies evaluating multiple investigational medicines as monotherapy or in combination with other therapies across a range of hematologic neoplasms and malignancies. Merck’s focus on cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www-merck-com.libproxy1.nus.edu.sg/research/oncology . About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ).