Rasagiline mesylate

看点 view 本周，中成药集采新进展，第十批国采拟中选结果公示出炉；市场迎变局，10个药被重点监控，广东开展国家医保谈判药品挂网工作；研发新动态，华海入局超20亿大品种，感冒中成药1类新药来袭；企业大新闻，百济神州引进石药抗肿瘤新药，东阳光药、恒瑞大动作，多家医药企业更改、终止募投项目，跨国药企巨头三高管同日离任......医药行业一周大事件，精彩不容错过！ 米内一周TOP榜 米内数据 34款止咳祛痰平喘中成药厉害了，独家品种涨116%第十批国采报价结果来了！倍特、科伦大丰收 药企动态 苑东口服止痛药剑指国产首家，拿下12个重磅新品扬子江开挂了！首仿品种涨逾100%这家中药企业手握22个独家品种，14款1类新药蓄力 审评药闻 药店大卖12亿的儿童药，江苏药企获批了石药改良型新药来袭，超2000亿市场掀波澜超2亿注射剂，最新国家药品标准曝光 第十批国采超50个产品价格“跳水”，明年4月落地 12月12日，第十批国采顺利开标。对比最高有效申报价，50多个产品降幅超过90%，最高降幅超过96%；原研药企继续“陪跑”，多个品种报出高价；国内过评头部药企仍为主角，倍特药业、齐鲁制药、科伦药业、正大制药等大厮杀。（米内网）划重点：当晚，全国药品集中采购拟中选结果公示出炉，公示时间截至12月16日，公示后将正式发布，国家医保局将指导各地及中选企业做好中选结果落地实施工作，确保全国患者于2025年4月用上本次集采中选产品。本次集采有62种药品采购成功，234家企业的385个产品获得拟中选资格。2018年以来，已组织开展10批国家组织药品集采，累计成功采购435种药品。 中成药集采新进展 12月11日，湖北医保服务平台发布全国中成药采购联盟集中采购相关数据信息的公示。第三批中成药纳入集采的共有20个中成药产品组，涉及95个产品。其中，生脉、益气复脉采购组是竞争最为激烈的产品，有97家企业参与。本次集采产品依然采用综合评审方式，入围采用综合评分方式按照价格、技术分别6:4的权重综合评估，评分考虑报价代表品降幅以及医疗机构认可度、综合排名、创新能力、药材品质、供应保障等因素综合得分，产生入围企业。（人民日报健康客户端）划重点：中成药集采如何“砍价”？国家医保局网站发布关于集采如何引导中成药价格回归合理的详细解读，湖北省牵头的全国中成药集中带量采购，一方面考虑当前中成药行业现状，一定程度认可同类药品的初始价格差异，另一方面多措并举压缩同类药品之间的价差，挤出虚高价格水分，让市场竞争更加公平公正。 109家企业、163个产品拟中选联盟集采 12月10日，河北牵头的京津冀化学药品集中带量采购拟中选结果公示，共163个产品拟中选。据梳理，此次拟中选的163个产品有90个已过评，1个产品为原研药品，阿斯利康、齐鲁、人福等109家企业拟中选（按申报企业计），涉及注射用苯唑西林钠、他克莫司软膏、盐酸纳布啡注射液等95个品种（含不同剂型）。（赛柏蓝） 425种药品，广东开展国家医保谈判药品挂网工作 12月10日，广东省药品交易中心发布关于做好2024年国家医保谈判相关药品挂网采购工作的通知，申报时间为自即日起至12月20日，涉及425种药品。（医药慧）划重点：谈判药品：协议期内的谈判药品按谈判确定的医保支付标准直接挂网采购。其中，已在省平台挂网的谈判药品的挂网价格高于医保支付标准的，2025年1月1日起挂网价格将调整为医保支付标准。竞价药品：参与现场竞价的企业，在支付标准有效期内，其竞价药品挂网价格不高于参与竞价时的报价。其中，已在省平台挂网的竞价药品的挂网价格高于竞价报价的，2025年1月1日起挂网价格将调整为竞价报价。调出目录药品：此前属于谈判药品或竞价药品现调出2024年目录的挂网药品，2025年1月1日起挂网方式将调整为挂网议价采购。 10个药被重点监控 12月9日，上海阳光医药采购网发布公告，公布2024年10月挂网公开议价超“黄线”、未通过公允性评估、重点监控药品幅度靠前且有一定采购金额的品种，10个药被纳入重点监控品种，包括4个中成药。（上海阳光医药采购网） 12月13日，石药集团发布公告称，公司已与百济神州就新型甲硫氨酸腺苷转移酶2A抑制剂SYH2039订立独家授权协议。公司将收取总计1.5亿美元的预付款，并有权收取最高1.35亿美元的潜在开发里程碑付款及最高15.5亿美元的潜在销售里程碑付款，此外还将根据该产品的年度销售净额计算分层销售提成。SYH2039是公司通过AI驱动的小分子药物设计平台获得的临床候选药物，主要靶向具有MTAP缺失突变的实体瘤，目前已在中国开展展I期臨床研究。（公司公告） 2.1亿元！丽珠单抗拿下流感重组蛋白疫苗项目专利 12月9日，丽珠集团公告称，公司控股子公司珠海市丽珠单抗生物与广东华南疫苗签署《流感重组蛋白疫苗项目专利及技术转让协议》。华南疫苗将三价及四价流感重组蛋白疫苗的项目权利转让给丽珠单抗，后者需支付最高不超过2.10亿元的技术转让费用，包括首付款、开发里程碑款及销售里程碑款，目标产品已获国家药监局批准开展临床试验。（公司公告） 华海入局超20亿大品种 12月14日，华海药业发布公告，其下属全资子公司浙江华海生物科技的阿达木单抗注射液上市许可申请获受理。米内网数据显示，阿达木单抗注射液在2023年中国三大终端六大市场销售额超过20亿元，2024年上半年同比增长5.45%。同日，公司还发布公告称，其产品甲磺酸雷沙吉兰片、西格列汀二甲双胍片(II)拟中选第十批国采。华海药业表示，若公司后续签订采购合同并实施后，将有利于上述产品快速打开国内销售市场，提高市场占有率，提升公司的品牌影响力，对公司未来经营具有积极影响。（公司公告） 感冒中成药1类新药来袭，200亿市场再掀波澜 12月10日，华纳药厂发布公告，公司在研项目乾清颗粒在国家药监局同意下开展Ⅱ期临床试验已于近期完成，并于近期收到临床试验总结报告。该产品是中药1.1类创新药，主要用于风热邪毒侵袭肺卫所致发热恶风，咽红肿痛，咳嗽痰黄，鼻塞流黄浊涕，口渴欲饮，舌红苔黄等症，普通感冒有上述症状者。（公司公告）米内数据：感冒中成药在2023年中国三大终端六大市场销售额超过200亿元，散剂/颗粒剂是TOP1剂型。 东阳光药、恒瑞两大医药龙头大动作 12月11日，东阳光长江药业发布公告，其控股股东广东东阳光药业（简称东阳光药）已向港交所提交上市申请。此次是东阳光集团医药资产资本运作的重要一步，东阳光药研发、生产和销售一体化进程全面提速，有利于东阳光药释放增长潜力，有望成为市值破千亿的国内医药龙头企业。12月10日，恒瑞医药发布公告，公司拟在境外发行股份（H股）并在港交所主板上市，恒瑞医药表示，此次是为深入推动科技创新和国际化双轮驱动战略，进一步助力公司国际化业务的发展。（公司公告） 产能扩展需求放缓，多家医药企业更改、终止募投项目 12月11日，博腾股份、首药控股等医药企业发布公告，对部分募投项目进行调整，涉及新药研发、中药饮片产能建设等项目。据不完全统计，近期还有万孚生物、维力医疗、寿仙谷等多家企业相继调整募投项目，涉及变更及募资用途或终止项目等。从变动原因来看，对现有产能或研发进展与未来市场预期的匹配情况为主因。（新京报） 跨国药企巨头三高管同日离任 12月11日下午，安进宣布多项重要人事变动。安进副总裁兼中国总经理许蔼龄、安进中国心血管事业部负责人吴海、安进中国骨科业务负责人范成敏同时离任。安进亚太区总经理柯美玲通过邮件向全体员工通报这一消息，并对三位离任高管过去对公司做出的贡献表示了感谢。柯美玲也表示，安进在中国的战略重心将保持不变，并希望与和员工共度这段变革期，迎接转型挑战。（E药经理人） 敛财1.5亿，医院原院长受审 据贵州六盘水中院消息，12月12日，原贵阳医学院党委委员、副院长，原贵阳医学院附属医院党委副书记、院长王小林案，在六盘水中院一审公开开庭审理。检方指控，2002年至2023年，他非法收受财物共计折合人民币1.5亿余元。（长安街知事微信公众号） 注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

Pooled data analysis of efficacy and safety from Phase 2b and Phase 3 data sets in patients with early-stage Parkinson’s disease (PD) support P2B001 as a first line, once-daily treatment choice for early PD KIRYAT ONO, Israel, Dec. 05, 2024 (GLOBE NEWSWIRE) -- Pharma Two B, a private, late-stage pharmaceutical company developing innovative combination drugs for neurological disorders, today announced a poster presentation of integrated safety and efficacy data on P2B001 from its Phase 2b and Phase 3 studies in early-stage Parkinson’s disease (PD) patients. P2B001 is a fixed, low-dose extended-release (ER) combination of pramipexole, 0.6 mg and rasagiline, 0.75 mg. The data are being presented today by Henry Moore, M.D., Associate Professor of Clinical Neurology, University of Miami, Miller School of Medicine, at the Parkinson’s Study Group (PSG) 33rd Annual Meeting in Nashville, TN. “The poster includes robust safety and efficacy data from two double-blind studies, which compared once-daily P2B001 to titrated pramipexole ER (PramiER) or placebo, over a 12-week period,” said Dr. Moore, Associate Professor of Clinical Neurology at the University of Miami and presenter of the study. “P2B001 consistently demonstrated a favorable risk-benefit profile in treating PD symptoms in early-stage patients, compared to the groups receiving other, commercially available therapies. It therefore could be a valuable potential first-line therapy for such patients who are often treated by general neurologists and primary care physicians.” The poster summarizes an integrated modified-ITT analysis of Unified Parkinson’s Disease Rating Scale (UPDRS) results in 196 early-stage PD patients, as follows: P2B001 had significantly greater effect on the UPDRS Part II (Activities of Daily Living, or ADL), Part III (Motor), and Total (Parts II and III) scores versus placebo.P2B001 had comparable efficacy to individually titrated PramiER.P2B001 had significantly less worsening in daytime-sleepiness compared to those treated with PramiER.P2B001 was well-tolerated with an adverse event profile that included fewer sleep-related and dopaminergic adverse events than titrated doses of PramiER. Dan Teleman, CEO of Pharma Two B, added, “These data provide further support for P2B001 as a first-line, once-daily combination pill treatment for people with early PD that requires no titration. Currently, we are focused on completing our merger with Hepion and thereafter look forward to moving P2B001 towards an NDA submission.” About the PSG Annual Conference The 2024 Annual Meeting of the Parkinson Study Group is being held December 5-8, 2024, in Nashville, TN. For over three decades, the PSG Annual Meeting has showcased the organization’s efforts in collaborative research and a commitment to education and mentorship. The meeting welcomes leading investigators, coordinators, trainees, advocates, and allied stakeholders to exchange the latest advances and practices in PD. About Pharma Two B Pharma Two B is a private, late-stage pharmaceutical company. Pharma Two B’s mission is to improve patients’ quality of life by developing innovative, value-added combination drugs for neurological disorders, with a clear unmet need, that are based on previously approved oral drugs and that may offer meaningful clinical benefits, as well as improved safety and enhanced convenience. Pharma Two B’s lead product candidate is P2B001. For more information, please visit: www.pharma2b.com. Pharma Two B plans to go public via a merger transaction (the “Merger”) with Hepion Pharmaceuticals, Inc. (Nasdaq: HEPA) (“Hepion”) in conjunction with the closing of a concurrent private placement. The proposed merger transaction was initially announced on July 22, 2024, and on November 11, 2024, the U.S. Securities and Exchange Commission (“SEC”) declared effective the Company’s registration statement on Form F-4, as amended (the “Registration Statement”) relating to the Merger. The Merger, which has been approved by the respective boards of directors of Pharma Two B and Hepion, is expected to close in the fourth quarter of 2024 and remains subject to approval by both Pharma Two B and Hepion’s respective stockholders, regulatory approval, listing of Pharma Two B’s ordinary shares on Nasdaq under the ticker symbol “PHTB” and other customary closing conditions. About P2B001 P2B001 is an investigational, novel, fixed-dose, extended-release combination of pramipexole and rasagiline (0.6 mg/0.75 mg), both at low doses that are not commercially available. Marketed pramipexole and rasagiline are currently indicated for the treatment of PD (as monotherapy and adjunct therapy for early and more advanced patients). P2B001 is being developed for potential use as a first-line therapy for people with PD. Extended release rasagiline is a new and proprietary formulation of rasagiline developed by Pharma Two B. In a Phase 3 clinical trial, P2B001 demonstrated that it provides benefits comparable with commercially used doses of marketed pramipexole-ER (PramiER) while minimizing associated daytime sleep-related and dopaminergic side effects. Pharma Two B owns worldwide-granted patents for both pharmaceutical composition and method of treatment with P2B001. About Hepion Pharmaceuticals Hepion is a biopharmaceutical company headquartered in Edison, New Jersey, previously focused on the development of drug therapy for treatment of chronic liver diseases. This therapeutic approach targets fibrosis, inflammation, and shows potential for the treatment of hepatocellular carcinoma (“HCC”) associated with non-alcoholic steatohepatitis (“NASH”), viral hepatitis, and other liver diseases. Hepion’s cyclophilin inhibitor, rencofilstat, was being developed to offer benefits to address multiple complex pathologies related to the progression of liver disease. In December 2023, Hepion’s board of directors approved a strategic restructuring plan to preserve capital by reducing operating costs. Additionally, Hepion initiated a process to explore a range of strategic and financing alternatives focused on maximizing stockholder value within the current financial environment and NASH drug development landscape. On April 19, 2024, Hepion announced that it has begun wind-down activities in its ASCEND- NASH clinical trial which wind-down activities have since been completed and the trial has been closed. Hepion is continuing efforts, to the extent that cash is available, to provide any value derived from rencofilstat to its shareholders. Forward-Looking Statements Certain statements in this press release may be considered “forward-looking statements”. Forward-looking statements generally relate to future events or Hepion’s or Pharma Two B’s future financial or operating performance. For example, express or implied statements regarding Hepion and Pharma Two B’s expectations with respect to the Merger, including the timing of the Special Meeting, listing Pharma Two B’s ordinary shares on Nasdaq, receipt of necessary shareholder approvals and the timing of closing of the Merger, and related matters, as well as all other statements other than statements of historical fact included in this press release, are forward-looking statements. When used in this press release, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions, as they relate to Hepion or Pharma Two B, identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, Hepion’s and Pharma Two B’s management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors detailed in Hepion’s and Pharma Two B’s filings with the SEC. Most of these factors are outside the control of Hepion and/or Pharma Two B and are difficult to predict. In addition to factors disclosed in Hepion’s and Pharma Two B’s filings with the SEC, the following factors, among others, could cause actual results and the timing of events to differ materially from the anticipated results or other expectations expressed in the forward-looking statements: the risk that the Merger may not be completed in the fourth quarter of 2024 or at all; the inability to meet the closing conditions to the Merger, including the failure of Pharma Two B to meet Nasdaq initial listing standards in connection with the consummation of the Merger; costs related to the Merger and the failure to realize anticipated benefits of the Merger or to realize estimated pro forma results with respect thereto as well as other risks associated with biopharmaceutical companies generally, including the risks of filing an NDA, obtaining regulatory approval for any product candidates, commercialization of any approved product, including P2B001 for PD, as well as the total addressable market and potential for success of P2B001, the presentation of financial information in U.S. GAAP, completion of a PCAOB audit of U.S. GAAP financials, as well as other risks set forth in more detail in the Registration Statement. The forward-looking statements are based upon management’s beliefs and assumptions; and other risks and uncertainties identified in the Registration Statement, including those under “Risk Factors” therein, and in other filings with the SEC made by Hepion. Each of Hepion and Pharma Two B undertake no obligation to update these statements for revisions or changes after the date of press release, except as required by law. No Offer or Solicitation This press release does not constitute an offer to sell or a solicitation of an offer to buy, or the solicitation of any vote or approval in any jurisdiction in connection with the Merger or any related transactions, nor shall there be any sale, issuance or transfer of securities in any jurisdiction where, or to any person to whom, such offer, solicitation or sale may be unlawful. Any offering of securities or solicitation of votes regarding the proposed transaction will be made only by means of a proxy statement/prospectus that complies with applicable rules and regulations promulgated under the Securities Act, and the Securities Exchange Act of 1934, as amended, or pursuant to an exemption from the Securities Act or in a transaction not subject to the registration requirements of the Securities Act. Additional Information and Where to Find It In connection with the Merger, Pharma Two B filed the Registration Statement with the SEC, which includes a prospectus with respect to its securities to be issued in connection with the Merger, and a definitive proxy statement with respect to Hepion’s stockholder meeting at which Hepion’s stockholders will be asked to vote on the Merger and related matters. The Registration Statement has been declared effective by the SEC and Hepion is mailing a definitive proxy statement and prospectus to its shareholders. Each of Hepion and Pharma Two B urge investors, stockholders, and other interested persons to read, when available, the Registration Statement including the proxy statement/prospectus, any amendments thereto, and any other documents filed with the SEC, before making any voting or investment decision because these documents will contain important information about the Merger. Investors and security holders will be able to obtain free copies of the Registration Statement, the proxy statement prospectus and all other relevant documents filed or that will be filed with the SEC by Pharma Two B or Hepion through the website maintained by the SEC at www.sec.gov. Participants in the Solicitation Pharma Two B and Hepion and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from Hepion’s stockholders in connection with the Merger. Information about Hepion’s directors and executive officers and their ownership of Hepion’s securities is set forth in Hepion’s filings with the SEC. To the extent that holdings of Hepion’s securities have changed since the amounts printed in Hepion’s Annual Report on Form 10-K/A, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC. A list of the names of such directors and executive officers and information regarding their interests in the Merger is contained in the proxy statement/prospectus in the Registration Statement. You may obtain free copies of these documents as described in the preceding paragraph. Contact: Pharma Two BDan TelemanCEOPharma Two B Ltd.Cell: + 972-54-550-0804Email: dan@pharma2b.comwww.pharma2b.com U.S. investors Chuck PadalaLifeSci Advisors, LLC+1-917-741-7792chuck@lifesciadvisors.com