Olaparib

精彩内容近日，青峰医药申报的4类仿制药盐酸决奈达隆片获批生产并视同过评。2024年至今，公司有18个品种获批生产并视同过评（3个首仿），目前总过评品种数已增加至44个（10个首家/独家），7大“光脚”品种备战第十一批集采。近年来，青峰医药以研发驱动为发展战略，2款1类新药获批上市，还有8款1类新药在国内处于申请临床及以上阶段；12个品种以新注册分类申报在审，其中有7个暂无首仿（含剂型首仿）获批。大丰收！拿下1款1类新药、3个首仿3月25日，青峰医药自主研发的化药1类新药玛舒拉沙韦片(GP681)获批上市，适用于既往健康的12岁及以上青少年和成人单纯性甲型和乙型流感患者的治疗，不包括存在流感相关并发症高风险的患者。据悉，该药是国内获批的首款国产流感病毒聚合酶酸性蛋白(PA)抑制剂，同时也是江西首个获批上市的化学药1类创新药。3月18日及11日，青峰医药申报的仿制药吡仑帕奈口服混悬液、口服溶液用盐酸万古霉素获批生产并视同过评，均为国内首仿+首家过评。米内网数据显示，2024年中国三大终端六大市场（统计范围详见本文末）万古霉素销售额超过20亿元。以审评结论日期计，2024年以来青峰医药在国内有1款1类新药获批上市，18个品种获批生产并视同过评，涉及抗肿瘤、抗癫痫、抗病毒、抗血栓形成、高血压、咳嗽感冒、抗细菌、抗贫血等细分领域。2024年以来青峰医药获批上市的品种来源：米内网中国申报进度（MED）数据库18个品种2024年在中国三大终端六大市场的销售额合计超过130亿元，其中硝苯地平控释片接近50亿元，罗沙司他胶囊超23亿元，贝前列素钠片、奥拉帕利片、瑞戈非尼片等超10亿元。上述品种中，青峰医药有多个品种为国内首批获批上市，其中吡仑帕奈口服混悬液、口服溶液用盐酸万古霉素、布立西坦片为国内首仿+首家过评，吡仑帕奈片国产第2家获批，伊布替尼胶囊、罗沙司他胶囊国产第3家获批，甲磺酸艾立布林注射液国产第4家获批等。值得一提的是，美索巴莫注射液是青峰医药首个获批生产的肌肉-骨骼系统化药，硫酸镁注射液为公司首款获批生产的矿物质补充剂。米内网数据显示，近年来中国三大终端六大市场肌肉-骨骼系统药物（化药）、矿物质补充剂（化药）销售额均分别超过400亿元、200亿元。44个品种过评！7大光脚品种备战第11批集采截至目前，青峰医药有44个品种过评或视同过评，其中吡仑帕奈口服混悬液、口服溶液用盐酸万古霉素、布立西坦片、甲磺酸多沙唑嗪缓释片、拉考沙胺注射液、甲苯磺酸索拉非尼片、艾司奥美拉唑镁肠溶片、拉考沙胺片、恩替卡韦胶囊、恩替卡韦分散片等为首家或独家过评（含并列）。青峰医药过评品种来源：米内网一致性评价进度数据库44个品种涵盖9个治疗大类，集中在抗肿瘤和免疫调节剂（10个）、神经系统药物（10个）、全身用抗感染药物（8个）等治疗领域。在过往开展的国家集采中，青峰医药累计有18个品种中选，其中在第十批国采中顺利中选了7个品种。此外，目前公司还有15个过评品种暂未纳入国采，其中有7个已满足7家及以上的充分竞争条件，包括5个口服常释剂型、1个注射剂、1个缓释控释剂型。青峰医药过评但未纳入国采且已满足入围门槛的品种注：销售额低于1亿元用*代替来源：米内网综合数据库从市场规模看，罗沙司他口服常释剂型、奥拉帕利口服常释剂型2个品种2024年在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端的销售额均超过10亿元，目前分别有17家、9家企业符合申报资格。从获批日期看，贝前列素钠片为青峰医药2025年1月新获批品种，罗沙司他胶囊、奥拉帕利片、恩扎卢胺软胶囊、美索巴莫注射液均为2024年获批品种，磷酸特地唑胺片、甲磺酸多沙唑嗪缓释片为2023年获批品种，目前公司在上述7个品种中所占的市场份额均为0。8款1类新药在路上！7个品种抢首仿据悉，青峰医药以研发驱动为发展战略，聚焦未满足的临床需求，每年以不低于年销售额10%的资金投入研发，专注于高价值、差异化的药品，形成了全球化、全链条的创新研发体系。3月25日，青峰医药自主研发的化药1类新药玛舒拉沙韦片(GP681)获批上市，适用于既往健康的12岁及以上青少年和成人单纯性甲型和乙型流感患者的治疗，不包括存在流感相关并发症高风险的患者。III期临床研究显示，该药可有效缩短流感症状缓解时间并快速清除病毒，同时具有良好的安全性和耐受性。2023年10月，青峰医药自主研发的中药1.2类新药枳实总黄酮片获批上市，该药具有行气消积、散痞止痛的功效，适用于功能性消化不良，症见餐后饱胀感、早饱、上腹烧灼感和上腹疼痛等。据不完全统计，目前青峰医药在国内有8款1类新药处于申请临床及以上阶段，集中在抗肿瘤药、抗感染药2大治疗领域。米内网数据显示，2024年中国三大终端六大市场抗肿瘤药（化药+生物药）、全身用抗感染药（化药+生物药）市场规模均超过1000亿元。青峰医药国内部分在研1类新药来源：米内网综合数据库仿制药方面，除了已获批/主动撤回品种，目前青峰医药有12个品种以新注册分类申报上市/临床，包括4个神经系统药物、4个抗肿瘤和免疫调节剂、2个消化系统及代谢药、1个皮肤病用药、1个全身用激素类制剂(不含性激素和胰岛素)。青峰医药新分类申报且在审的品种来源：米内网中国申报进度（MED）数据库7个品种在国内暂无仿制药获批，包括利那洛肽胶囊、布立西坦口服溶液、布立西坦注射液、阿贝西利片、拉米地坦片、依伏卡塞片、瑞卢戈利片。其中，阿贝西利是礼来开发的一种周期蛋白依赖性激酶4和6(CDK4和CDK6)的抑制剂，2024年全球销售额超过53亿美元。资料来源：米内网数据库、公司公告等注：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。数据统计截至4月30日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。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

CHICAGO — A new type of targeted cancer drug that blocks a “DNA caretaker” protein called Werner helicase has captured the attention of several big pharma companies in recent years, and the first data appear to reinforce its potential. Cells are typically equipped with critical redundancies for important proteins, but when they mutate in cancer patients, a single protein can become the key to a cell’s life or death. By finding the proteins that aberrant cancer cells need to function and then blocking them, drug developers are building the next generation of targeted cancer treatments. Roche now has the first data for its experimental drug, which takes advantage of what’s known as synthetic lethality, in gynecologic and colon cancers. It was shared this week at the American Association for Cancer Research’s annual meeting in Chicago. In the span of six years, scientists and physicians took a promising drug target identified via CRISPR screening and created a handful of experimental treatments for cancer patients. There are now four different Werner helicase-targeting agents in early-stage clinical trials from Roche, Novartis, GSK and Nimbus Therapeutics — a private drug developer with a track record of doing big deals. “Werner helicase really and truly represents a synthetic lethal vulnerability and therefore a therapeutic opportunity in MSI cancers,” said Timothy Yap, a physician-scientist with the University of Texas MD Anderson Cancer Center, referring to cancers with a specific DNA signature. “That’s really the crux of it and why it was so exciting.” Synthetic lethality is a phenomenon that scientists are exploiting to develop new targeted cancer treatments. Their inspiration is PARP inhibitors (such as AstraZeneca’s Lynparza), a class of drugs used to treat a wide range of cancers including breast and ovarian. PARP inhibitors are a synthetic lethal therapy for cancers with BRCA mutations. In the Phase 1 study, Roche’s experimental drug led to four confirmed responses — two in endometrial cancer, one in colorectal cancer, and one in ovarian cancer — in 35 patients. There was also a fifth unconfirmed response in endometrial cancer. Yap presented the data Sunday at the AACR meeting. The responses mean the drug, which came from Roche’s partnership with Vividion Therapeutics in 2020, shrank the tumors in these patients at least 30%. It’s the first time that researchers have shown the effect of a Werner helicase blocker in people. Many of the patients in the study had gone through several previous treatment regimens. While their cancers were found in a wide range of locations, most of the tumors were considered microsatellite instable, which is a sign of DNA misrepair that physicians frequently look for in cancer diagnoses. The initial science that identified Werner helicase as a potential target showed that knocking it out was lethal to the microsatellite instable cells, and this piqued the interest of drug developers. Microsatellite instability-high cancers make up around 3% of all cancer cases, according to some estimates. The responses to Roche’s drug occurred at a range of doses, from 150 mg a day to 1,000 mg twice a day. In an interview, Ryan Corcoran, director of the gastrointestinal cancer center program at the Massachusetts General Hospital Cancer Center, said there’s not a clear correlation between the responses and dose levels. Researchers typically look for dose dependency (more drug equals better efficacy) in clinical studies as a green flag the treatment is working as intended. Corcoran, who chaired the session where Roche’s clinical trial results were presented, consults for Roche but not on the Werner helicase project. The primary side effects related to the drug were nausea, vomiting and diarrhea. There were no dose-limiting toxicities. Like Novartis had already reported, both GSK and Nimbus disclosed at the meeting that their molecules were non-covalent, meaning they do not permanently bind Werner helicase. This leaves Roche as the lone company developing a covalent, or permanently binding, agent in clinical trials. GSK suggested in its presentation that its drug could work in tumors that acquired resistance to Roche or Novartis’ compounds, but that’s based on animal model data and has not been shown in humans. GSK’s drug comes from a partnership with Ideaya Biosciences, a biotech company that’s focused on developing drugs against synthetic lethalities. In 2019, four papers were published showing Werner helicase could be a promising target for treating microsatellite instable cancers. These cancers tend to respond well to immunotherapy, but patients have few other options beyond those treatments. Of the two studies published in Nature on the same day, one was from Mathew Garnett’s lab at the Wellcome Sanger Institute, while the other was led by Adam Bass, who at the time was at the Dana-Farber Cancer Institute and now leads translational cancer research at Novartis. Using CRISPR screening, researchers from both groups found that Werner helicase was needed in microsatellite instable cancer models but dispensable in models that were microsatellite stable. “When you knock out Werner helicase, in 48 hours, the cells are dead,” Garnett said. “All their DNA is just shattered, and it’s really phenomenal. You had this sense when you saw this genome shattering, that there was something really profound happening to these cells.” There are several other synthetic lethality programs in early-stage trials. Corcoran said he has yet to see results from another class of synthetic lethal drugs that matches the success of PARP inhibitors, though many of these efforts are still early and have yet to report clinical data. One closely-watched effort to leverage synthetic lethality is targeting a protein called PRMT5 in cancers with mutations known as MTAP deletions. This is an area in which Bristol Myers Squibb, Amgen, Ideaya and others are all working on early-stage programs, though readouts so far have been mixed . Eli Lilly and Foghorn Therapeutics last year began a Phase 1 trial for a SMARCA2 inhibitor, which they are studying in patients with SMARCA4-mutated cancers. “Imagine you’re riding a bicycle — it’s a bicycle with two wheels — and one of the wheels is lost, and now you’re riding a unicycle,” Foghorn CEO Adrian Gottschalk said. And so giving a SMARCA2 inhibitor to one of these patients is like taking a stick to the cancer cell’s remaining wheel, he said.