Melinta Subsidiary Corp.

SAN DIEGO, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing immunotherapeutics designed to help improve the standard of care for patients facing serious diseases, today reported financial results for the second quarter ended June 30, 2023 and provided an update on its corporate activities and product pipeline. “This quarter we made important progress in the advancement of our Cloudbreak® drug-Fc conjugate (DFC) platform,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “Most recently, we received Fast Track designation for CD388, which is being developed in collaboration with Janssen Pharmaceuticals for the prevention of influenza A and B infection in adults who are at high-risk of severe influenza. Moreover, we continue to generate compelling data from ongoing preclinical studies of CD421, a CD73-targeting DFC, and our first oncology product candidate, which we intend to present at future scientific conferences.” Dr. Stein continued, “Looking ahead, we anticipate filing an Investigational New Drug Application (IND) in 2024 for CD421, a potential first-in-class inhibitor of CD73. We look forward to providing further data from our promising Cloudbreak programs at our planned R&D Day in the second half of this year.” Recent Corporate Highlights REZZAYO™ commercialization in the U.S. by Melinta: On July 31, 2023, Melinta Therapeutics, LLC (Melinta), initiated the commercial launch of REZZAYO in the U.S. Update on status of ongoing CD388 influenza program: In March 2023, Cidara announced promising interim Phase 2a data assessing the safety and efficacy of a single dose of CD388 evaluating the pre-exposure prophylactic activity of CD388 against the H3N2 influenza A virus strain. The planned interim analysis of the Phase 2a study provided preliminary evidence that CD388 may effectively prevent influenza and supports our belief in the potential of DFCs from our Cloudbreak platform. Final results of the Phase 2a study are expected later in 2023. As part of a recent prioritization of its R&D business, in July 2023 Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceuticals Companies of Johnson & Johnson, disclosed its intention to discontinue internal development of multiple product candidates in its infectious disease pipeline, including JNJ-0953 (CD388). However, Janssen has not informed Cidara of any intention to terminate the collaboration agreement between the two parties. Cidara continues to work in collaboration with Janssen to complete the Phase 1 and Phase 2a clinical trials and will be reimbursed for all ongoing development activities by Janssen as per the Janssen Collaboration Agreement. Within 90 days after Cidara delivers the complete CD388 Phase 2a data package to Janssen, Janssen is required to notify Cidara whether it will proceed with further clinical development and commercialization of CD388. If Janssen delivers an Election to Proceed, it is obligated at its sole expense to diligently continue development and commercialization either itself or through a third party to whom it sublicenses or assigns the rights. If Janssen sublicenses or assigns the rights to a third party, then all terms under the current Janssen Collaboration Agreement will survive without modification. Should Janssen not provide an Election to Proceed within the 90-day period, Cidara would have the right to terminate the agreement and retain the CD388 program, including all data and materials funded by Janssen’s investment in the program. U.S. Food and Drug Administration (FDA) granted Fast Track designation to CD388: In June 2023, Cidara received Fast Track designation for CD388, the Company’s novel DFC candidate being developed in collaboration with Janssen for the prevention of influenza A and B infection in adults who are at high-risk of severe influenza, including those for whom vaccines are either ineffective or contraindicated. Companies that are granted this designation are given the opportunity for more frequent interactions with the FDA, and, if relevant criteria are met, eligibility for Priority Review. Joined the Russell Microcap® Index: In June 2023, Cidara joined the broad market Russell Microcap Index at the conclusion of the Russell U.S. Indexes annual reconstitution. Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $12.1 trillion in assets are benchmarked to or invested in products based on the Russell U.S. Indexes. Presented at the 2nd Annual Adenosine-Pathway Targeted Cancer Immunotherapy Summit: In June 2023, Cidara delivered an oral presentation including highlights from its ongoing preclinical studies of CD421, as well as the utility and flexibility of its novel DFCs from the Company’s Cloudbreak platform, at the 2nd Annual Adenosine-Pathway Targeted Cancer Immunotherapy Summit. Second Quarter 2023 Financial Results Revenue totaled $7.6 million and $33.6 million for the three and six months ended June 30, 2023, respectively, compared to $6.2 million and $13.3 million for the same periods in 2022, respectively. The increase was primarily attributable to the revenue recognized in connection with the Melinta regulatory milestone achieved in March 2023. The remaining revenue for all periods relates to the ongoing research and development and clinical supply services provided to Mundipharma Medical Company, Janssen and Melinta. Cash and cash equivalents totaled $50.4 million as of June 30, 2023, compared with $32.7 million as of December 31, 2022. Research and development expenses were $17.1 million and $35.9 million for the three and six months ended June 30, 2023, respectively, compared to $15.3 million and $35.4 million for the same periods in 2022, respectively. The research and development expenses for all periods primarily relate to clinical expenses associated with the rezafungin clinical trials and certain drug manufacturing costs before FDA approval, as well as clinical expenses and drug manufacturing costs associated with the Cloudbreak platform. General and administrative expenses were $3.3 million and $7.6 million for the three and six months ended June 30, 2023, respectively, compared to $4.1 million and $9.3 million for the same periods in 2022, respectively. The decrease in general and administrative expenses is primarily due to lower consulting, personnel and legal costs, offset by higher amortization of contract costs related to obtaining the Melinta License Agreement. Net loss for the three months ended June 30, 2023 was $12.4 million, compared to a net loss of $13.1 million for the same period in 2022. For the six months ended June 30, 2023 and 2022, net loss was $9.1 million and $31.4 million, respectively. During the three months ended June 30, 2023, Cidara sold 60,942 shares of common stock, at a weighted average price of $1.28 per share for gross proceeds of approximately $0.1 million, before deducting placement agent fees pursuant to its at-the-market sales agreement. During the six months ended June 30, 2023, Cidara sold 6,219,741 shares of common stock, at a weighted average price of $1.44 per share for gross proceeds of approximately $9.0 million, before deducting placement agent fees pursuant to its at-the-market sales agreement. As of June 30, 2023, Cidara had 90,251,746 shares of common stock outstanding and 2,104,472 shares of Series X Convertible Preferred Stock outstanding, which are convertible into 21,044,720 shares of common stock. About Cidara Therapeutics Cidara is developing immunotherapeutics designed to help improve the standard of care for patients facing serious diseases. The Company’s portfolio comprises new approaches aimed at transforming existing treatment and prevention paradigms, including DFCs from its proprietary Cloudbreak® platform targeting oncologic, viral and autoimmune diseases. In addition, Cidara recently received FDA approval for REZZAYO™ (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit Forward-Looking Statements This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether we and Janssen will complete Phase 1 and Phase 2a clinical trials for the CD388 influenza program and whether Janssen will elect to continue clinical development of CD388 following delivery of the Phase 2a data package, whether REZZAYO will be prescribed by physicians or reimbursed by payors following its U.S. launch, and whether we will complete all requirements for submission of an IND for CD421 or submit an IND in 2024. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s preclinical or clinical trials, delays in action by regulatory authorities due to limitations on inspections and other COVID-19-related effects, and other obstacles on the enrollment of patients or other aspects of CD388 development. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. INVESTOR CONTACT: Brian Ritchie LifeSci Advisors (212) 915-2578 britchie@lifesciadvisors.com MEDIA CONTACT: Veronica Eames LifeSci Communications (646) 970-4682 veames@lifescicomms.com CIDARA THERAPEUTICS, INC. Condensed Consolidated Statements of Operations (unaudited) Three Months Ended June 30, Six Months Ended June 30, (In thousands, except share and per share data) 2023 2022 2023 2022 Revenues: Collaboration revenue $ 7,614 $ 6,216 $ 33,604 $ 13,325 Total revenues 7,614 6,216 33,604 13,325 Operating expenses: Research and development 17,135 15,255 35,850 35,421 General and administrative 3,310 4,074 7,608 9,278 Total operating expenses 20,445 19,329 43,458 44,699 Loss from operations (12,831 ) (13,113 ) (9,854 ) (31,374 ) Other income (expense): Interest income (expense), net 623 (6 ) 855 (26 ) Total other income (expense), net 623 (6 ) 855 (26 ) Net loss before income tax expense (12,208 ) (13,119 ) (8,999 ) (31,400 ) Income tax expense (149 ) — (149 ) — Net loss and comprehensive loss $ (12,357 ) $ (13,119 ) $ (9,148 ) $ (31,400 ) Basic and diluted net loss per common share $ (0.14 ) $ (0.19 ) $ (0.11 ) $ (0.46 ) Shares used to compute basic and diluted net loss per common share 90,115,859 69,133,700 84,409,667 68,638,651 Condensed Consolidated Balance Sheet Data June 30, 2023 December 31, 2022 (In thousands) (unaudited) Cash and cash equivalents $ 50,430 $ 32,731 Total assets 67,986 47,593 Total liabilities 52,572 50,497 Total stockholders’ equity (deficit) 15,414 (2,904 )

New Treatment for Candidemia and Invasive Candidiasis Now Available in the U.S. PARSIPPANY, N.J.--(BUSINESS WIRE)-- Melinta Therapeutics, LLC today announced the availability of REZZAYO™ (rezafungin for injection), for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. REZZAYO is the first new treatment option approved for patients with candidemia and invasive candidiasis in over a decade. Based on Qualified Infectious Disease Product (QIDP) designation, REZZAYO was approved under Priority Review. This press release features multimedia. View the full release here: (Photo: Business Wire) While echinocandins have been available since the early 2000’s, their use has been primarily limited to the hospital in-patient setting due to their requirement of daily IV infusions. In contrast, REZZAYO is administered as a once weekly infusion, creating the opportunity for appropriate patients to leave the hospital sooner to continue their treatment at home, potentially reducing the burden on patients and the healthcare system. John Harlow, Chief Commercial Officer for Melinta Therapeutics said, “Making REZZAYO available in the U.S. is another way Melinta will leverage our expansive commercial infrastructure and experience launching products and therapies into acute care environments with the ultimate goal of better patient care and outcomes.” Last year, Melinta announced that it had acquired the exclusive rights to commercialize REZZAYO in the U.S. from Cidara Therapeutics. Once-weekly REZZAYO is available by prescription beginning July 31, 2023. Harlow added, “The availability of REZZAYO, the first new treatment of its kind in over a decade, is a major step forward in offering healthcare providers a way to simplify and treat patients suffering from invasive Candida infections. It’s a much-needed option for physicians, and those patients who may be able to transition out of the hospital sooner.” About REZZAYO™ (rezafungin for injection) INDICATIONS AND USE REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data. REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida. IMPORTANT SAFETY INFORMATION Contraindications REZZAYO™ is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins. Warnings and Precautions Infusion-related Reactions: REZZAYO™ may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion. Photosensitivity: REZZAYO™ may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation. Hepatic Adverse Reactions: Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO™. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO™ therapy. Adverse Reactions Most common adverse reactions (incidence ≥ 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia. Please see full Prescribing Information for REZZAYO™ (rezafungin for injection), available at . About Melinta Therapeutics Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO™ (rezafungin for injection), TOPROL-XL® (metoprolol succinate) and VABOMERE® (meropenem and vaborbactam). For more information about Melinta Therapeutics, our commitment to patients, and to learn about our portfolio of therapies, visit Melinta.com.

▲8月03-04日 CMC-China大会 · 限时免费扫码报名中注：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。任何文章转载需得到授权。美国东部时间7月20日，Endpoints对2023年生物医学领域的20位杰出女性（Women in Biopharma 23）榜单做出公布。在生物技术的最高职位上，女性的代表性仍然很低，然而这些杰出代表在生物医药领域冲锋陷阵，未来将有更多的女性在这条道路上获得成功，推动生物医学的发展。01连续创业者帮助其他女性创办自己的公司Sangeeta Bhatia麻省理工学院（MIT）马伯尔癌症纳米医学中心主任Bhatia博士在2020年与其同事创建了麻省理工学院教员创始人计划（MIT Faculty Founder Initiative），旨在帮助麻省理工学院的更多女性创办自己的生物技术公司。Glympse Bio公司是其中一个出自她实验室的公司，其专注于开发微创活检技术协助各式疾病的诊断。该公司开发了一种可吸入的呼吸分析仪版本以及一种液体活检版本的微创活检技术，可以通过简单的抽血来检测疾病。他们在纤维化疾病中的先导项目已经完成了1期试验，该团队正在研究另一个检测和监测肝癌的候选项目。02CAR-T专家引领下一代平台Jennifer Brogdon诺华（Novartis）生物医学研究所免疫肿瘤和血液学细胞与基因治疗负责人2011年，Brogdon博士与宾夕法尼亚大学的早期CAR-T细胞治疗合作伙伴展开合作，并最终带来了诺华的CAR-T疗法Kymriah（tisagenlecleucel）治疗淋巴瘤。Brogdon博士并率先开发一个名为T-Charge的下一代平台，T-Charge疗法是一种名为rapcabtagene autoleucel (YTB323) 的自体CD19定向CAR-T细胞疗法，可以在不到两天的时间内生产出来。诺华二月份表示，正在一线治疗高风险大B细胞淋巴瘤患者中评估该候选药物。诺华称该平台可以在加快细胞生产过程的同时促进患者应答。03细胞治疗初创公司首席运营官谈论制造和获取Kathryn Penkus Corzobit.bio总裁兼首席运营官Kathryn Penkus Corzo于2021年加入bit.bio，担任首席运营官，此前该生物技术公司获得了1.03亿美元的B轮融资，并在大型制药公司工作了数十年。现在已经18个月了，她将把职业生涯的下一部分奉献给细胞疗法。她拥有肿瘤学背景，曾任赛诺菲isatuximab项目负责人，isatuximab是一种CD38抗体，于2020年获得FDA批准用于三线多发性骨髓瘤，现在品牌为Sarclisa。Corzo女士认为通过改善来源细胞、降低成本和解决患者免疫功能低下的挑战是使得细胞疗法能造福更多患者的关键。“我想把我职业生涯的下一阶段致力于发展能使细胞疗法造福数百万患者的能力。”Corzo女士说道。04辉瑞高管寻求发挥制药巨头合作伙伴的作用Kathy Fernando辉瑞CentreOne高级副总裁和负责人Fernando领导辉瑞CentreOne和最近推出的辉瑞Ignite，分别是这家制药巨头的CDMO部门以及端到端开发和临床服务项目。这Fernando长期以来一直对免疫学和传染病感兴趣。在博士学位即将结束时，她对科学与商业的交叉点特别感兴趣，这促使她在德勤(Deloitte)从事咨询工作，然后于2014年加入辉瑞(Pfizer)，曾担任mRNA科学规划主管。费尔南多说，辉瑞现在专注于生态系统的一个特定子集，主要寻找符合“高创新标准”、在科学上有前景并带来属于其重点研发领域的想法的合作伙伴。05Alnylam首席执行官对下一波RNAi疗法寄予厚望Yvonne GreenstreetAlnylam首席执行官Greenstreet博士在2016年加入Alnylam，担任首席运营官，当时该公司仍在试图证明它可以用合成的RNA分子（称为小干扰RNA）来制造药物，以阻止致病蛋白质的产生。今年早些时候，Alnylam报道了一项新的壮举：表明单次注射实验性RNAi疗法可以在很长一段时间内击倒与阿尔茨海默病相关的蛋白质。这标志着该公司首次涉足脑部疾病领域，这一举措由首席执行官Yvonne Greenstreet领导。06为了追求“毫无疑问的全新”，Normunity首席执行官突破了I/O的界限Rachel HumphreyNormunity创始首席执行官Humphrey博士目前领导Normunity，这是一家由耶鲁大学教授陈列平共同创立的早期初创公司，其研究为PD-1/PD-L1免疫疗法成为癌症治疗的基石铺平了道路。现在，在Normunity，结合了“正常”和“免疫”这两个词，Humphrey博士和他的团队正在开发抗体，他们希望能够打破免疫系统和肿瘤细胞之间的墙壁，这样身体的正常免疫系统或免疫疗法就可以进入并清除癌症。7.8两位科学家在追随科学的过程中冒着风险，帮助Dupixent成为了超级重磅炸弹▲Elizabeth Laws（左）与Marcie Ruddy（右）女士Elizabeth Laws，赛诺菲副总裁兼免疫学和炎症全球项目负责人& Marcie Ruddy，Tectonic Therapeutic首席医学官当Dupixent于2017年首次获批用于治疗特应性皮炎时，它的重磅炸弹地位还远未确定。在赛诺菲的Laws和再生元的Marcie Ruddy成为两位关键科学家的指导下，通过一系列临床开发策略，使得Dupixent现在成为一款用于超过60万名病患、治疗多项适应症的重要疗法。他们的策略部分是基于当他们对科学充满信心时将药物直接进入III期研究。Dupixent通过阻断IL-4和IL-13两种分子来调节称为2型炎症的免疫反应。为了弄清楚接下来该在哪里服用这种药物，Laws和Ruddy搜索了整个疾病领域，寻找与2型炎症相关的病症。09表示分散式临床试验将继续存在Michelle LongmireMedable首席执行官Medable是一家专注开发分散临床试验（DCT）平台的公司，至今其已完成超过5亿美元的融资。Medable总部位于加利福尼亚州，是一家以患者为中心、帮助药物研究人员将临床试验扩展到医院以外的临床研究云平台提供商。该平台现已通过在60个国家/地区的150多个分散和混合临床试验部署其SaaS平台，为全球超过100万患者和研究参与者提供服务。10Moderna早期研究负责人描绘了mRNA技术超越疫苗的未来Rose LoughlinModerna研究与早期开发高级副总裁Rose Loughlin博士领导着一支大约500人的团队，其中大部分是科学家，他们主要从事Moderna研发管线中未列出的项目。其中包括除传染病疫苗之外的所有治疗领域的探索性研究和临床前研究，以及该公司致力于改进其mRNA和脂质纳米颗粒技术的平台科学团队。这包括针对除传染病疫苗以外，所有治疗领域的探索性研究和临床前研究，以及其mRNA和脂质纳米颗粒技术平台的改进。11CAR-T领导者的非传统生物制药之路Crystal Mackall斯坦福癌症细胞治疗中心创始主任、CARGO Therapeutics联合创始人作为一名对免疫学感兴趣的医生，Mackall博士在美国国立卫生研究院（NIH）就职期间加入该机构癌症免疫疗法的研究计划，并成为生物医药公司在CAR-T疗法上的领导者之一。她在NIH的第一项任务是研究T细胞稳态。她的研究帮助确定了胸腺在调节T细胞中的作用，为后代干细胞疗法奠定了基础。她希望她早期在骨髓移植方面的工作，以及如何选择性地移植供体细胞而不进一步消耗其他细胞的见解，有一天可能会为此类患者带来强度较低的预处理方案。12Melinta首席执行官在抗生素领域渡过难关Christine Ann MillerMelinta Therapeutics首席执行官兼总裁Miller女士在2020年担任Melinta Therapeutics的首席执行官兼总裁，加入公司一年后制定了成为抗生素以外急症护理领域领导者的计划。该公司正在推出一种新的抗真菌药物Rezzayo，该药物于3月份获得批准用于治疗念珠菌血症和侵袭性念珠菌病。13认识一下“从头开始”构建Organon研发管线的女性Sandra MilliganOrganon研发负责人Milligan博士曾在安进(Amgen)、基因泰克(Genentech)和默克(Merck)等公司担任过职务。正是这种终生价值的角色促使她担任目前默克旗下女性健康生物制药子公司Organon的研发主管一职。Organon是一家来自默沙东、专注于妇女健康疗法开发的生物科技公司。Milligan博士正在领导建立一个妇女健康新药的管线——这是一些大型药企在近期没有那么感兴趣的治疗领域。然而她认为，在一家专注于女性健康的公司里才有机会真正聚集女性的声音，并强调这类早期临床公司需要更多机会来完成其疗法开发的目标。14首席科学官描绘 癌症治疗的“新未来”Li PengPalleon Pharmaceuticals首席科学官Palleon Pharmaceuticals专注于开发靶向唾液酸多糖（sialoglycans）来调节癌症患者免疫系统以治疗癌症的疗法。Peng博士在Palleon公司完成4700万美元的A轮融资后的数月加入担任发现高级总监一职，并于2020年成为该公司的首任首席科学官。Palleon目前的方法是使用一种酶来裂解唾液聚糖末端的唾液酸，防止其与称为siglecs的抑制性受体结合。Palleon公司最近向美国癌症研究协会（AACR）递交1期试验数据，表明其主要候选药物E-602显示出剂量依赖性的去唾液酸化和免疫系统激活的迹象。15通过解决关键挑战，这位高管可以帮助再生元在基因药物领域赢得新的声誉Leah Sabin再生元基因疗法执行总监Sabin博士在2015年加入再生元后不久便开始研究解决基因疗法在肝外递送问题的潜在方案。Sabin用抗体片段装饰了AAV（基因治疗的主力）的表面，这些抗体片段可以引导病毒进入肌肉、穿过血脑屏障或进入其他难以到达的器官。她还帮助开发了双特异性抗体，这类抗体可通过同时靶向AAV与特定细胞类型来促进病毒载体的靶向递送。Sabin目前正致力于将这些工程病毒与CRISPR基因编辑疗法配对，以帮助将DNA插入基因组的特定位点。她希望与Intellia Therapeutics 共同开发的这项技术能够带来更持久的治疗，特别是对于随着成长可能失去基因疗法益处的儿童。16Genmab愿景的关键规划者带领抗体制造商度过风雨Martine van VugtGenmab执行副总裁兼首席战略官多年来，van Vugt博士在Genmab公司倡导一种战略业务开发方法，推动其抗体疗法向前发展。她倡导采用战略业务发展方法来推动Genmab的抗体发展，然后围绕她在职业生涯早期研究过的同一抗体（daratumumab）领导了交易谈判。强生(J&J)旗下杨森(Janssen)于2012年获得了该药物的许可，并于2015年被批准为Darzalex，这是目前市场上七种Genmab产品中的第一个。17传染病专家强调团队合作和压力下的恢复能力Tonya Villafana阿斯利康（AstraZeneca）疫苗和免疫治疗全球特许负责人兼副总裁Tonya Villafana在生物制药领域的职业生涯跨越了数十年，跨越了多个国家和大洲。现在，她担任阿斯利康副总裁兼传染病全球特许经营负责人，此后一直致力于疟疾、流感、埃博拉病毒的研究，最近还研究了一种RSV抗体，该抗体获得FDA批准，可在婴儿的第一个RSV季节提供保护。这种预防性抗体被称为Beyfortus，是通过与赛诺菲合作创建的。虽然赛诺菲在美国主导该项目的启动，但Villafana是阿斯利康该项目的首席科学家。18构建生物技术初创公司和女性领导力网络Angie YouArchitect Therapeutics首席执行官2021年12月，赛诺菲宣布收购当时由You博士担任首席执行官的Amunix癌症疗法开发公司。在完成此交易不久，You博士接任了Architect Therapeutics公司首席执行官一职。在她加入Amunix之前，她曾在麦肯锡与风投公司Venrock就职，并在之后协助Aragon公司进行了首次公开募股（IPO），并向杨森进行出售。在Sierra Oncology期间，她获得如何出售项目许可的经验，其中一项便是GSK所收购的JAK抑制剂momelotinib。19经验丰富的企业家希望将基因疗法引入中国并使其负担得起郑静（Jane Zheng）Belief BioMed共同创始人兼首席执行官Belief BioMed 目前即将申请中国首个B型血友病基因疗法的批准，该公司已在多轮融资中筹集了数亿美元，并建立了大量项目。Belief BioMed 发现自己跻身于临床上提供基因疗法的十几家生物技术公司之列。随着血友病B主导项目的注册试验完成给药，该公司目前正在等待52周的数据，以便在来年的某个时候提交NDA申请。在其背后，郑的300多人团队提出了一系列涵盖罕见和常见疾病的基因疗法，她希望有一天这些疗法不仅能治疗中国的患者，还能治疗包括中东和东南亚在内的周边地区的患者。20一群妈妈解析研究、发起非营利组织并筹集资金以改变罕见疾病的药物开发罕见病组织的妈妈领袖（Mom Leaders of Rare Disease Organizations）她们称自己为“罕见病妈妈”，有时也称自己为“斗士妈妈”。当他们的孩子被确诊时，他们的旅程就开始了，然后医生告诉他们回家，珍惜剩下的不多的时间。然而她们并不屈服命运的安排，通过解析研究，启动非营利组织并筹集资金以尝试和激发新的治疗方法。她们同时也在重塑如何为微小患者群体进行临床试验的方式。多亏了这些妈妈，罕见病的治疗前景正在改善。生物技术融资的低迷导致许多制药商搁置了家庭资助的疗法。但这并没有阻止家族组建实验室、公司和合资企业，将控制权交到他们手中。他们正在开发患者登记系统，消除数据孤岛并吸引制药投资。今年5月，一项称为“定制基因治疗联盟（Bespoke Gene Therapy Consortium）”、金额达9700万美元的合作计划获启动，旨在加快针对8种超罕见病症的基因疗法，并为其他疾病提供疗法开发路线图。他们也敦促监管机构进行改革。通常，针对极罕见疾病的临床试验无法找到足够的患者。为了回应妈妈们和其他罕见疾病倡导者的要求，FDA正在重新考虑其方法。参考资料：ENDPOINTS文中图片均来自ENDPOINTS