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跨国药企战略调整进行时。 安斯泰来（Astellas）正在重新调整其研发管线，将重点放在后期机会上，并终止一些早期研究项目。 而在不久前，安斯泰来对公司高层职位进行重大调整，其中包括首席科学官Yoshitsugu Shitaka博士和首席制造官Hideki Shima的离职，并将现任首席医学官Tadaaki Taniguchi博士升任为新设立的首席研发官职位。 1 砍管线、调结构 安斯泰来制药集团（Astellas Pharma Inc.）是一家总部位于日本东京的跨国制药企业，成立于2005年，由原日本山之内制药株式会社与藤泽制药株式会社合并而成。 公司不仅拥有前列腺癌神药安可坦（Xtandi）这一重磅新药，还在新晋热门的抗体药物偶联物（ADC）领域大获成功，其Padcev获批与默沙东的Keytruda联合用于一线治疗膀胱癌。 然而，在研发回报率持续走低的大环境下，安斯泰来也开始战略转向，聚焦更易成功的领域。 据悉，安斯泰来公司正在进行一项为期四年的成本削减计划，旨在到2027财年结束时（届时与辉瑞合作的前列腺癌药物Xtandi预计将在美国失去市场独占权）实现1200亿至1500亿日元（8亿至10亿美元）的年度成本节约。 根据Fierce Pharma消息，安斯泰来将终止多个早期项目，优先推进20+后期管线。 同时，安斯泰来对公司高层职位进行重大调整，其中包括首席科学官和首席制造官的离职，并将现任首席医学官Tadaaki Taniguchi博士升任为新设立的首席研发官职位。 2 聚焦后期项目 近年来，安斯泰来在新型技术上投入了大量资金。 2019年，安斯泰来通过连续收购Audentes Therapeutics和Xyphos Biosciences在细胞和基因治疗方面进行了大量投资。去年，公司还与慢病毒载体递送专家Kelonia Therapeutics、同种异体CAR-T生物技术公司Poseida Therapeutics（最近被罗氏收购）和基因组医学专家Sangamo Therapeutics建立了合作关系。 目前，安斯泰来多个项目已接近概念验证阶段的结果读出，但公司对开发进度仍不满意。而且，安斯泰来巨额收购的基因疗法AT132，在临床试验中导致四名患者死亡。 在遭遇了一些挫折以及大型制药公司在CGT行业的普遍撤资后，安斯泰来也失去了耐心。安斯泰来首席战略官Adam Pearson表示，公司将把更多重点转向后期机会，将更多精力投入到风险较低的治疗方式上。 “我们将把投资转向更多较为成熟的治疗方式，如双特异性抗体、免疫刺激性抗体偶联药物（ADCs）、蛋白降解疗法等”Pearson说。 此前，安斯泰来已与辉瑞合作开发了明星ADC药物Padcev，该药在膀胱癌治疗中取得了突破性成功。Pearson表示，如果有“合适的、处于后期阶段的、适合引进许可的机会”，公司可能会引进更多ADC项目。 此外，安斯泰来还关注神经肌肉疾病、免疫肿瘤学、失明与再生以及靶向蛋白降解疗法，在这些领域或将进行更多收购或引进管线。 3 结语 安斯泰来的战略转向并非孤例。在研发回报率持续走低、政策监管趋严的行业背景下，诺华、赛诺菲等巨头近期也纷纷调整管线，“更有效地将资源分配给最有前途的项目”，以期在日益激烈的市场竞争中保持竞争力。 参考来源： 1.https://www.fiercepharma.com/pharma/astellas-shifts-investment-focus-later-stage-opportunities-amid-reprioritization 2.稳稳队：又一家日本药企，大变动 声明：本内容仅用作医药行业信息传播，不代表药智网立场。对本文有异议或投诉，请联系maxuelian@yaozh.com。 责任编辑 | 小月石 合作、投稿 | 马老师 18323856316（同微信）  阅读原文，是受欢迎的文章哦

Cancer is well represented in the Astellas Pharma portfolio and pipeline, but the drugmaker has made diversification a key part of its growth strategy. Newer products in its drug lineup include a vision-loss disorder drug and a first-in-class therapy for menopause symptoms. Cell and gene therapies are also a key part of Astellas’s growth strategy, building off of its 2020 acquisition of gene therapy developer Audentes Therapeutics. Within gene therapy, the Tokyo-based company is focused neuromuscular disorders, Chief Medical Officer Tadaaki Taniguci said in an interview last week during the annual J.P Morgan Healthcare Conference in San Francisco. “Our strategy in the past is more developing our capability,” Taniguci said. “We actually acquired Audentes, developing our capabilities toward gene therapy. But now we see that the more important thing for us is to really bring in clinical-phase assets to our pipeline.” Exclusive Improving the Healthcare Financial Experience to Help Care Flow Zelis CEO Amanda Eisel shares her perspective on how the company is solving the problems of a fragmented health financial system to benefit all. By Stephanie Baum The Astellas pipeline is split nearly 50/50 between internally developed drug candidates and assets from acquisitions or external collaborations. Audentes brought AT132, a gene therapy for the rare neuromuscular disease X-linked myotubular myopathy. This program has been beset by setbacks due to patient deaths in the trial. But Audentes also brought programs for two rare other rare disorders, Pompe disease, an inherited disorder that leads to muscle weakness, as well as Friedreich’s ataxia, which causes cardiomyopathy. Both programs are in early clinical development. Astellas is still expanding its gene therapy prospects through deals. Last October, the company paid AviadoBio $50 million for the option to license the biotech’s lead gene therapy, which is in early clinical development for frontotemporal dementia, a neurodegenerative disorder with no FDA-approved treatments. The deal structure is similar to a 2022 agreement that gave Astellas the option to license a Taysha Gene Therapies program for Rett syndrome, a disorder that leads to developmental problems. Phase 1/2 safety and efficacy data for this Rett therapy, TSHA-102, are expected in the first half of this year. Astellas remains willing to strike deals that give it new tools that expand its capabilities in gene therapy, Taniguci said. The company is already developing gene therapies delivered to their bodily destinations carried aboard adeno-associated viruses (AAV). These engineered viruses preferentially go to the liver. In 2021, Astellas began a research collaboration with Dyno Therapeutics focused on discovering novel capsids — the protein shells that envelop a genetic payload — for delivery to skeletal and cardiac muscle. Last month, Astellas began a partnership with Sangamo Therapeutics, securing the right to use one of that biotech’s proprietary capsids to penetrate the brain and reach neuronal targets, which Taniguci said fits with his company’s neuromuscular disease strategy. Penetrating the blood-brain barrier “is the one biggest challenge to overcome to target the [central nervous system],” he said. “So they help us to create much better access to the target organ. We see more platform development together with them to actually create the next generation of gene therapy.” Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech In oncology, the company’s top products are Xtandi, a small molecule drug for prostate cancer, and Padcev, an antibody drug conjugate for bladder cancer. A Phase 3 study is evaluating Padcev in combination with the Merck immunotherapy Keytruda as a treatment for muscle-invasive bladder cancer. Data are expected in Astellas’s next fiscal year, which starts on April 1. Additional clinical studies are testing Padcev in non-muscle-invasive bladder cancer and other solid tumors. Astellas is pursuing other approaches to cancer. Its in-house R&D has yielded ASP3082, the company’s lead targeted protein degrader drug for cancer. This drug candidate targets the cancer-driving protein KRAS G12D. At the European Society of Medical Oncology (ESMO) meeting last September, Astellas reported preliminary Phase 1 data showing anti-tumor activity in patients with pancreatic, colorectal, and non-small cell lung cancers. Taniguci noted the results indicate a dose-dependent degradation of the target protein. Astellas will need to show differentiation from other companies developing KRAS G12D-targeting drugs, such as Revolution Medicines and Bristol Myers Squibb, via the pharma giant’s acquisition of Mirati Therapeutics. But Astellas envisions potentially bringing its targeted protein degradation approach to multiple KRAS mutations. “This is a new technology that we started using for KRAS G12D, but we also have a pan-KRAS product coming to the clinic pretty soon,” Taniguci said. “We also started expanding more to other targets. We cannot disclose yet, but [there’s] a lot of excitement.” Astellas’s newest cancer drug is Vyloy, which in October became the first FDA-approved drug targeting claudin 18.2, a protein highly expressed in gastrointestinal cancers. This internally developed drug is a monoclonal antibody. The Astellas pipeline includes another program targeting claudin 18.2, but with a bispecific antibody. This program, ASP2138, is in Phase 1 testing. Women’s health is a newer piece of Astellas’s portfolio coming with the 2023 FDA approval of Veozah, a non-hormonal drug for treating vasomotor symptoms caused by menopause. The first-in-class therapy is a small molecule designed to block neurokinin 3, a receptor that plays a role in regulating body temperature. Last month, the FDA added a black box warning on the product’s label, flagging the risk of severe liver injury. Taniguci said liver toxicity is a known risk that was first observed in clinical trials. None of those cases were severe. In the market, the product has been used by about 100,000 patients. “Liver tox is relatively rare, but sometimes we see the severe cases,” Taniguci said. “That’s why I think it’s important to provide cautions for the patient and physician to use this important medicine. But of course we believe that the benefit/risk balance is really positive. So that’s why we still hear a lot of patients willing to use Veozah in treatment of [vasomotor symptoms].”