Pyridoxine Hydrochloride

据药智数据统计，4月共有203个品种通过/视同通过一致性评价，涉及198家企业（以集团企业进行统计），其中49家企业为多品种过评，以上海复星医药（集团）股份有限公司过评品种数最多，有7个品种通过/视同通过一致性评价。4月，通过/视同通过一致性评价品种数量为半年来之最，突破200大关，有203个品种过评；一致性评价申报方面，4月申报品种数再降，半年内申报品种数最少。PS：药智网公众号【ID:yaozh008】后台回复【一致性4月】，即可获取本文表格excel格式文档01一致性评价过评情况1.一致性过评整体情况4月，通过/视同通过一致性评价的品种数量明显增长，较3月增长了63.71%，共203个品种通过/视同通过一致性评价；其中61个品种为一致性评价补充申请过评，153个品种为仿制药上市视同通过一致性评价。图1 2023年09月-2024年04月一致性过评趋势在已收集到的上市批文信息中，13个品种为首家过评，7个品种为一致性评价补充申请首家过评，其中二羟丙茶碱注射液在一致性补充申请过评前，已有1家企业以仿制药上市视同通过一致性评价。由于部分新批准药品还没能收集到详细信息等原因，导致一致性评价数据库中的数据和注册数据可能会存在差异，现在将整理出的2024年4月首家过评的药品信息放在文末附表1中，供参考。2.企业过评品种数情况从企业过评品种数而言，4月通过/视同通过一致性评价品种数量为半年来之最，共有203个品种过评，涉及198家集团企业，其中49家为多品种过评。4月，上海复星医药（集团）股份有限公司有7个品种通过/视同通过一致性评价，过评品种数最多；其次为齐鲁制药有6个品种过评；然后是上海医药集团、浙江华海、浙江天宇药业均有4个品种过评。图2 2024年4月企业过评品种数TOP 10备注：榜单数据按持有人对应的集团企业进行统计上海复星医药（集团）股份有限公司及子公司目前已有106个品种通过/视同通过一致性评价，其中以一致性评价补充申请过评的品种共有54个，4月过评的品种为：布美他尼注射液、盐酸格拉司琼注射液；以仿制药上市视同通过一致性评价的品种同样有54个，4月共5个品种过评，分别为：阿立哌唑口腔崩解片、盐酸胺碘酮注射液、盐酸罗哌卡因注射液、环丝氨酸胶囊和盐酸舍曲林片。注：由于海复星医药（集团）股份有限公司各子公司生产的注射用奥美拉唑钠和氨甲环酸注射液，既有以一致性评价补充申请过评的企业，也有以仿制药上市视同通过一致性过评的企业，因此集团公司过评品种数与通过和视同通过品种数之和不一致。齐鲁制药集团有限公司及子公司目前已有160个品种通过/视同通过一致性评价，其中以一致性评价补充申请过评的品种共有58个品种，4月过评的品种为卡维地洛片；仿制药上市视同通过一致性评价的品种同样有104个，4月共5个品种过评，分别为：瑞戈非尼片、头孢克洛胶囊、注射用醋酸西曲瑞克、头孢泊肟酯片、盐酸苯达莫司汀注射液。注：由于齐鲁制药各子公司生产的左西孟旦注射液和注射用培美曲塞二钠，既有以一致性评价补充申请过评的企业，也有以仿制药上市视同通过一致性过评的企业，因此集团公司过评品种数与通过和视同通过品种数之和不一致。3.品种过评企业数情况从品种过评企业数而言，4月有54个品种为多企业过评，其中他达拉非片过评企业数最多，有5个企业，其次为吸入用硫酸特布他林溶液和间苯三酚注射液，各有4家企业过评。图3 2024年4月品种过评企业数TOP 10备注：榜单数据按药智规范后的药品名称进行统计他达拉非片目前已有53家企业均以仿制药上市，视同通过一致性评价，4月视同通过一致性评价的企业有5家，分别为：安徽贝克药业有限公司、浙江康恩贝制药股份有限公司、昆明源瑞制药有限公司、通化万通药业股份有限公司、植恩生物技术股份有限公司。吸入用硫酸特布他林溶液目前已有13家企业均以仿制药上市，视同通过一致性评价，4月视同通过一致性评价的企业有4家，分别为：新加坡Star Pharmaceutical Pteltd（新加坡斯达制药有限公司）、南京力成药业有限公司、健民药业集团股份有限公司、海南葫芦娃药业集团股份有限公司。间苯三酚注射液目前已有19家企业通过/视同通过一致性评价，其中2家企业以一致性评价补充申请通过一致性评价，还有17家企业以仿制药上市，视同通过一致性评价。4月视同通过一致性评价的企业有4家，分别为：德元堂制药集团有限公司、绪必迪药业（河北）有限公司、华夏生生药业（北京）有限公司、丽彩医药集团有限公司。4.ATC分类情况4月通过/视同通过一致性评价的品种中，消化道及代谢用药成功挤掉系统用抗感染药，成为过评品种数最多类型，有52个品种过评，占品种总数的19.05%；其次为心血管系统用药，有40个品种过评，占14.65%；然后是系统用抗感染药，有38个品种过评，占13.92%。图4 2024年4月品种通过品种ATC分布情况备注：榜单数据按品种数除重后，通过一致性评价品种ATC分类1级分类进行统计5.集采情况2024年04月过评的品种中，45.05%已纳入集采，集采品种中系统用抗感染药最多，共有20个品种，未纳入集采品种中，消化道及代谢用药最多，有33个品种。图5 2024年4月品种通过品种集采情况备注：榜单数据按药智规范后的药品名称进行统计图6 2024年4月纳入集采品种ATC分类情况备注：榜单数据按药智规范后的药品名称进行统计图7 2024年4月未纳入集采品种ATC分类情况备注：榜单数据按药智规范后的药品名称进行统计6.参比制剂情况在参比制剂方面，4月已过评的203个品种中，仅有6个品种官网无参比制剂正式通稿，其余品种均有参比制剂正式通稿信息。无参比制剂(正式通稿)信息的品种分别为：碳酸钙咀嚼片、盐酸左氧氟沙星片、苯磺酸左旋氨氯地平片、枸橼酸铋钾颗粒、富马酸依美斯汀缓释胶囊、格列吡嗪分散片。02一致性评价申报情况1.一致性申报整体情况从下图8可知，从2023年9月至2024年2月，一致性评价补充申请的品种数一直维持在50个品种左右，在2024年3月和4月，申报一致性评价的品种数量有所降低，均只有32个品种。在仿制药上市方面，虽然从2024年1月开始，申报数量成降低趋势，但4月，申报品种数回升，有218个品种申报。图8 2023年9月至2024年04月申报详情备注：数据按药品名称除重后进行统计2.品种申报企业数情况4月，除注射用头孢呋辛钠、注射用头孢唑肟钠、盐酸格拉司琼注射液、维生素B6注射液、甲磺酸酚妥拉明注射液5个品种均有2家企业申报以外，其余均为单企业申报品种。3.企业申报品种数情况2024年4月，除石药控股集团有限公司、上海现代制药股份有限公司、灵康药业集团股份有限公司各有2个品种申报，其余企业均为但品种申报。石药控股集团有限公司目前已有111个品种通过/视同通过一致性评价，4月申报的品种为：注射用苯唑西林钠、注射用头孢唑肟钠。上海现代制药股份有限公司目前已有54个品种通过/视同通过一致性评价，4月申报的品种为：盐酸格拉司琼注射液、硫酸镁注射液。灵康药业集团股份有限公司目前已有9个品种通过/视同通过一致性评价，4月申报的品种为：注射用维库溴铵、注射用头孢呋辛钠。4.一致性评补充申请ATC分类情况从申报一致性评价补充申请药品的ATC分类而言，系统用抗感染药依旧是最受申报企业企业青睐的领域，有14个品种申报，其次为心血管系统和消化道代谢领域。详情见下图。图9 2024年4月申报一致性评价品种ATC分类备注：榜单数据按通过一致性评价品种ATC分类1级分类进行统计5.一致性评补充申请参比制剂情况4月，申报一致性评价补充申请的32个品种中，29个品种国家已公布参比制剂正式通稿信息，仅有2个品种暂无（受理号为CYHB2450255的维生素B？注射液，由于不确定具体品种，未纳入统计），这两个品种分别为：别嘌醇缓释胶囊和复方甘草酸苷胶囊。附表1：2024年4月首家通过一致性评价详情表附表2：2024年4月通过（含视同通过）一致性评价（过评厂家数为2-5）详情表附表3：2024年4月申报一致性评价详情表数据来源：药智数据企业版——仿制药一致性评价分析系统声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 德清君转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信） 阅读原文，是昨天最受欢迎的文章哦

Harmonia Healthcare's chief scientific officer, Marlena Fejzo, Ph.D., will also leverage her groundbreaking discovery of the hormone associated with HG to drive innovations in prognostics, prevention and treatments. Harmonia Healthcare, a new provider focused on specialty women’s health, has opened a clinic in New Jersey to treat hyperemesis gravidarum (HG).  HG can bring nausea and vomiting during pregnancy severe enough to prevent proper food intake and can lead to weight loss, dehydration and ultimately hospitalization. It can cause complications for mothers and their babies and is estimated to affect up to nearly 11% of pregnant women. Harmonia’s new clinic will offer evidence-based treatments and educate patients on the latest science around HG. Its offerings include medication and vitamin infusion, electrolyte replacement plans, prescription management, diagnostic bloodwork and telehealth. A second clinic is planned to open in New York City this fall. The clinic does not require referrals.   Its chief scientific officer, Marlena Fejzo, Ph.D., a women’s health researcher with lived experience of HG, will also leverage her and colleagues' groundbreaking discovery of the hormone associated with the condition—GDF15—to drive innovations in prognostics, prevention and treatment. Fejzo was a 2023 Fiercest Women in Life Sciences awardee.  “We really want to fix the broken care model in women’s health and improve care,” Fejzo told Fierce Healthcare. “We hope to expand this to be the future of care for these undertreated and underdiagnosed diseases.”  Harmonia’s online platform will offer educational resources and eventually telehealth, though women should still ideally first come into the clinic in person. The current status quo for women with HG is unacceptable and costly, Fejzo says. If they end up in an emergency room, they are treated with fluids or antiemetic drugs and released. But because HG causes persistent nausea and vomiting, women need persistent medication management, Fejzo argues. If they are discharged without a prescription, many will inevitably wind up back in the hospital again; 60% of women have multiple hospital visits, per Fejzo.  And, while HG is starting to be diagnosed properly more often, Fejzo said, it can still be misdiagnosed or not diagnosed at all.  “A lot of people think that it’s just regular nausea and vomiting and that everything’s going to be fine … when actually there are really adverse outcomes associated with HG for the mother and the baby,” Fejzo said.  During a recent conference, Fejzo said she discovered ER doctors affiliated with Harvard discharge HG patients without a prescription. Their justification for it was that the medications might make them tired, and then they would have to miss work. “That’s a real misunderstanding of HG,” Fejzo said, adding that if Harvard-affiliated docs are doing it, “I assume it is common.”  RELATED: New study finds cause and potential treatment for dangerous morning sickness Part of the reason Fejzo believes this is happening is due to a famous historic incident known as the thalidomide disaster. After women being treated with thalidomide for nausea had babies with birth defects, it launched a widespread hesitancy to prescribe medications during pregnancy, Fejzo said. There also remains a misguided belief that HG is psychological or resolves on its own.  And because HG typically starts early in pregnancy, many women see ER docs before even seeing their obstetrician, meaning many providers may not be aware of how sick their patients have really been. Obstetricians are also generally not trained to ask their patients about their levels of nausea and vomiting—and patients, too, may not talk about it, Fejzo explained. To address this, Harmonia will be monitoring women receiving medication management and coordinating with their other providers, like OB-GYNs, midwives and doulas. The goal is to intervene as early as possible with more aggressive treatment before the condition spirals out of control. The best medications for HG being prescribed off-label include Zofran, Phenergan and Reglan, according to Fejzo. Yet doctors usually begin with doxylamine and pyridoxine, as recommended by the American College of Obstetricians and Gynecologists, which Fejzo says are “pretty much a placebo for HG.”  By serving patients with HG, Harmonia will have the infrastructure in place to run clinical trials on potential new treatments, Fejzo said. She is already advising NGM Bio, which recently announced it is interested in testing its drug NGM120 in HG patients.  While Fejzo doesn’t anticipate challenges with patients getting their scripts filled, Harmonia providers will educate patients on how to have conversations with pharmacists in case they do run into pushback. In recent years, pharmacists have sometimes refused to fill opioid prescriptions with doses they perceived as too high or poorly monitored by the prescriber. One of the country’s only other clinics in this space, Alabama’s Morning Sickness Clinic, claims its model has led to a 95% reduction in ER visits and a 90% decrease in total cost of care. Its co-founder, an emergency medicine physician, is one of Harmonia’s clinical advisers.  Harmonia eventually hopes to expand to serve other under-researched women’s health conditions. While the company does not currently plan to pursue formal health system partnerships, it hopes that its clinics will come to be known locally as the go-to expert for these conditions.  And, while it isn’t yet, Harmonia plans to be working with commercial and Medicaid insurance plans by the end of this year.