Canagliflozin/Metformin Hydrochloride

9月14日，上海宣泰医药的达格列净二甲双胍缓释片三个规格首仿过评，成为该明星复方降糖药物的国内首仿。 但值得注意的是，该产品原研有5个规格，上海宣泰医药仅过评三个，两个规格被驳回。具体理由未可知。 *此规格指的是达格列净和二甲双胍的配比 根据药融云数据库显示，达格列净2023年医院全终端销售额已达40亿元，而二甲双胍一直是糖尿病治疗药物“一哥”。 达格列净+二甲双胍的组合物专利尚有3年到期，仿制大战就已开启，上海宣泰是以化药3类申报过评的，阿斯利康的原研产品在2022年2月开始申请在国内上市，23年6月获批，而上海宣泰等不及原研在国内上市就进行了仿制申报。 与上海宣泰情况一致的是正大天晴，于2023年2月进行了3类申报，相较于其他企业等着原研在国内上市后才进行的4类申报，这两家企业都做到了快人一步。 正大天晴一边仿制上市一边对原研的专利进行了无效申请，2024年6月对达格列净+二甲双胍的组合物专利发起了专利无效申请，虽然失败了，但正大天晴的思路还是很正确的，先过评再攻破专利，争取能早日销售。 目前该品种尚有有9家企业在申请上市。 图| 达格列净二甲双胍缓释片上市申请 医学上对于肥胖伴随其他基础性疾病的糖友有一个221方案，里面的两个2就是分别指二甲双胍和SGLT-2抑制剂，达格列净就属于SGLT-2抑制剂，与二甲双胍联合使用可针对性控制血糖，221方案里的1代表GLP-1目前基本都是注射液，暂未有复方制剂上市暂且不论，二甲双胍加SGLT-2抑制剂的复方性药物已上市诸多，降血糖的同时可以给心肾带来保护。 图源：丁香园 SGLT-2抑制剂还有恩格列净、卡格列净、恒格列净等，这些都可以跟二甲双胍形成复方制剂。 二甲双胍恩格列净片原研共5个规格，目前已有3个规格有过评产品，2个规格依旧为勃林格殷格翰独有，勃林格殷格翰的二甲双胍恩格列净片（I）注册证到期未续，可以看出这类复方制剂并不是掌握了其中一种配比就能完成所有规格的申报。 图|二甲双胍恩格列净片上市文号 有意思的是二甲双胍恩格列净片只有中美华东的规格在销售，连勃林格殷格翰都未有销售数据。 二甲双胍+恩格列净的组合专利已宣告无效，目前尚有36家企业，46个受理号在申请一致性评价，加上原研和已上市企业6家，二甲双胍恩格列净片竞争格局是42家企业，与达格列净二甲双胍相比，真正的卷王是它。 图|二甲双胍恩格列净片上市申请 恩格列净二甲双胍缓释片国内未有上市，原研同样是勃林格殷格翰，正因为专利已宣告无效，常释剂型已有36家企业上报，缓释片也有多家申请上市了，但不只是缓释片技术较常释片难处许多，申请上市7家，目前已有4家被驳回了。 恒格列净二甲双胍缓释片山东盛迪以2.3类改良新药上市，国内独家，且没有其他企业有临床或上市信息，可以独占市场较久。 卡格列净二甲双胍片，曾经华东医药和哈尔滨珍宝制药做过申报，但也仅限于获批临床，未有下文了。 卡格列净二甲双胍缓释片原研强生，美国已上市，且被列入参比，乐普药业提交过上市申请，被驳回了，华海药业正在临床中，乐普药业当时被驳回有可能是仅做BE试验通不过，但依据达格列净二甲双胍缓释片能仅做BE试验顺利过评的情况看，不一定是这个原因。 慢病用药一直是兵家必争之地，从阿卡波糖到二甲双胍，再到达格列净片，都创造过销售神话，产品从单方制剂卷到了复方制剂，这常卷王之战不知会延续到几时。 注：以上数据仅代表常见的SGLT-2抑制剂与二甲双胍的复方制剂不代表全部。 投稿/内容沟通：华籍美人（Ww_150525） 近期精华文章

Dr. Douglas E. Williams as Head of Research and Development Dr. Gary Meininger as Chief Medical Officer SEATTLE, April 10, 2023 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced the appointments of two senior leaders to its research and development organization, Douglas E. Williams, Ph.D., as President of Research and Development, and Gary Meininger, M.D., as Chief Medical Officer. In a planned transition, Sunil Agarwal, M.D., Chief Medical Officer, will leave the company after helping onboard these new executives. Dr. Williams has over three decades of experience leading R&D organizations and companies, including at Biogen, ZymoGenetics, Seattle Genetics, Amgen, and Immunex, and most recently he was CEO of Codiak BioSciences. In his career, he has participated in the development of over a dozen approved medicines across multiple therapeutic areas, including multiple blockbusters. Dr. Meininger has over two decades of experience in drug development leadership, most recently at Vertex and previously at both Janssen and Merck. He is currently the industry representative to the FDA’s Endocrine and Metabolic Drug Advisory Committee. “We are thrilled to welcome Doug and Gary to Sana,” said Steve Harr, Sana’s President and CEO. “We are making rapid progress in transitioning from a research-based company to one focused on delivering innovative gene and cell-based medicines to patients across multiple disease areas. These accomplished and experienced leaders are recognized innovators in their respective areas of expertise, and together we believe they will strengthen our strategies, execution, and teams. Doug's long track record of transforming novel science into important medicines for patients will be useful across our portfolio, while Gary’s initial focus will be on our oncology pipeline with the recent IND allowance for SC291 and upcoming INDs for SC262 and SG299.” Dr. Harr added, “I would like to take this occasion to thank Dr. Sunil Agarwal for his work in building the development organization and ushering forward Sana’s pipeline, including the company’s first product candidate to IND clearance. Sunil has been a partner in defining the company strategy and hiring top talent into the company, and we wish him much success in his next endeavor.” Douglas E. Williams, Ph.D. Dr. Williams was most recently the President and CEO of Codiak BioSciences. From January 2011 to July 2015, he was the Executive Vice President of Research and Development at Biogen. He joined Biogen from ZymoGenetics, where he was most recently CEO and member of the board of directors, during which time, the company was purchased for $985M by Bristol Myers Squibb. Previous leadership positions include Chief Scientific Officer and Executive Vice President of Research and Development at Seattle Genetics, Senior Vice President and Washington Site Leader at Amgen, and Executive Vice President and Chief Technology Officer at Immunex. During his biotechnology career spanning over 30 years, he has played a role in the development of multiple novel drugs, including Enbrel®, Tecfidera®, and Spinraza®. He has served on the board of numerous biotechnology companies and is currently Chairman of the Board of AC Immune and a Director for Panacea II and Codiak. Dr. Williams obtained a B.S. from the University of Massachusetts Lowell and a Ph.D. from the State University of New York at Buffalo. Gary Meininger, M.D. Dr. Meininger was previously at Vertex as Senior Vice President, Head of Clinical Development for Vertex Cell and Genetic Therapies (VCGT), overseeing all aspects of clinical development for VCGT. Prior to Vertex, Dr. Meininger spent more than eight years at Janssen where, as Vice President, Franchise Medical Leader in the Cardiovascular-Metabolism Therapeutic Area, he oversaw the clinical and regulatory advancement of various products including Invokana® (canagliflozin) and Invokamet® (canagliflozin/metformin). Prior to joining Janssen, Dr. Meininger worked at Merck Research Laboratories for eight years where he was a core member of the Januvia® (sitagliptin) and Janumet® (sitagliptin/metformin) programs. Dr. Meininger is the industry representative to the FDA’s Endocrine and Metabolic Drug Advisory Committee. For over 16 years, Dr. Meininger maintained an endocrine clinical practice at Robert Wood Johnson University Hospital. He received a B.S. in Biological Sciences from Binghamton University and an M.D. degree from New York University School of Medicine. Dr. Meininger completed his residency in Internal Medicine at New York-Presbyterian Hospital and his fellowship in Endocrinology at the Massachusetts General Hospital. About Sana Biotechnology Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are a passionate group of people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, Cambridge, South San Francisco, and Rochester. For more information about Sana Biotechnology, please visit . Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements about Sana Biotechnology, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the Company’s vision, progress, and business plans and expectations for its development programs, product candidates and technology platforms, including its pre-clinical, clinical, and regulatory development plans and timing expectations, including with respect to the expected timing of IND filings for the Company’s product candidates; and expectations for its management personnel, including their expected impact and areas of focus. All statements other than statements of historical facts contained in this press release, including, among others, statements regarding the Company’s strategy, expectations, cash runway and future financial condition, future operations, and prospects, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company’s current and future research and development programs, preclinical and clinical trials, as well as economic, market, and other disruptions, including due to the ongoing COVID-19 public health crisis. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s SEC reports, including but not limited to its Annual Report on Form 10-K dated March 16, 2023. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason. Investor Relations & Media: Nicole Keith investor.relations@sana.com media@sana.com