Polichem SA

「  本文共：16条资讯，阅读时长约：3分钟 」今日头条恒瑞MOR靶向镇痛药获批上市。恒瑞医药1类新药富马酸泰吉利定注射液（SHR8554）获国家药监局批准上市，适用于腹部手术后中重度疼痛。SHR8554可激活μ阿片受体（MOR），选择性地激活G蛋白偶联通路，具有中枢镇痛效果的同时，可减轻胃肠道不良反应和减少呼吸抑制不良反应的发生率。今年1月，CDE已受理该新药提交的“骨科手术后镇痛”新适应症上市申请。国内药讯1.和黄「呋喹替尼」获批香港上市。和黄医药VEGFR抑制剂呋喹替尼（fruquintinib）获香港监管部门批准上市，用于治疗既往接受过氟尿嘧啶类、奥沙利铂和伊立替康为基础的化疗，以及既往接受过或不适合接受抗VEGF治疗、抗EGFR治疗（RAS野生型）的转移性结直肠癌患者。在国际III期试验 (MRCT) FRESCO-2研究中，与安慰剂相比，呋喹替尼治疗组的mOS延长2.6个月，mPFS延长1.9个月。2.科笛引进非那雄胺喷雾剂报产。科笛集团从Polichem公司引进的外用非那雄胺喷雾剂CU-40102的新药上市申请（NDA）获CDE受理，用于治疗雄激素性脱发。与口服非那雄胺不同，CU-40102可直接精确地涂抹在头皮表面，保持用药部位高浓度并减少药物全身暴露。在Ⅲ期临床中，CU-40102治疗组24周时患者的顶部秃发目标区域内的总毛发计数及终毛计数的统计较安慰剂显著改善。3.辉瑞CD3/BCMA双抗中国报产。辉瑞CD3/BCMA双抗Elranatamab（Elrexfio,PF-06863135）的上市申请获CDE受理，用于治疗复发或难治性多发性骨髓瘤（R/R MM）。在II期研究MagnetisMM-3（NCT04649359）研究中，elranatamab在既往至少接受过四种治疗的患者中达到61%的客观缓解率以及56.1%的非常好的部分缓解率。去年8月，该产品已获FDA加速批准上市，成为第二款在美获批的CD3/BCMA双抗。4.驯鹿BCMA靶向CAR-T见刊PNAS。驯鹿生物靶向BCMA的CAR-T产品伊基奥仑赛注射液（CT103A）在研究者发起的一项针对免疫介导坏死性肌病（IMNM）的探索性研究（NCT04561557）中获积极结果。CT103A回输18个月后，患者徒手肌力检查（MMT-8）评分从基线的96分，改善至137分；血清肌酸激酶水平从4778 IU/L降至260 IU/L，肌红蛋白水平从837 ng/mL降至66.2 ng/mL；临床中未发现新的安全性风险。详细结果发表在《美国国家科学院院刊》（PNAS）上。5.荣昌预计2023年营收10.8亿元。荣昌生物发布2023年年度业绩预告，预计2023年度营业收入约108,000万元，较上年同期将增加收入约31,000万元，同比增加约40%;预计实现归属于母公司所有者的净亏损约155,000万元，较上年同期将增加亏损约55,200万元，同比亏损增加约55%；预计归属于母公司所有者扣除非经常性损益后的净亏损约158,000万元，较上年同期将增加亏损约46,400 万元，同比亏损增加约42%。6.中国生物制药南方总部开业运营。1月31日，中国生物制药南方总部在广州国际生物岛正式开业。南方总部目前已引入包括治疗非酒精性脂肪性肝炎的拉尼兰诺、软雾吸入药械平台Softhale和新一代肿瘤免疫疗法等海外临床项目。未来，中国生物制药将通过南方总部和海外子公司invoX，引进全球领先的药品管线，并在广州实现临床转化和产业化。国际药讯1.BMS靶向CD19自体CAR-T报两项sBLA。FDA受理百时美施贵宝CD19靶向CAR-T疗法Breyanzi（Liso-cel）两项补充生物制品许可申请（sBLA），用于治疗复发或难治性滤泡性淋巴瘤（FL）和套细胞淋巴瘤（MCL）经治患者。FDA同时授予它们优先审评资格，PDUFA日期分别为今年5月23日和5月31日。在临床试验中，Breyanzi在复发/难治性FL患者中达到97%（p<0.0001）总缓解率（ORR）；在MCL患者达到86.5%的ORR。2.强生CD38单抗皮下注射制剂报新适应症。强生CD38抗体皮下注射制剂Darzalex Faspro（daratumumab）已向FDA提交补充生物制品许可申请（sBLA），联合硼替佐米、来那度胺和地塞米松（D-VRd）用于适合接受自体干细胞移植（ASCT）的新诊断多发性骨髓瘤成人患者的诱导和巩固治疗，以及之后联合来那度胺（D-R）用于维持治疗。在III期PERSEUS研究中，47.5个月随访数据显示，daratumumab联合方案使疾病进展风险降低58%。3.NaV1.8抑制剂两项止痛Ⅲ期临床积极。Vertex公司选择性NaV1.8抑制剂VX-548用于术后（腹部整形手术和拇囊炎切除手术）中重度急性疼痛治疗的两项Ⅲ期临床均达到主要终点。与安慰剂相比，VX-548组患者48小时内疼痛强度差异的时间加权总和评分（SPID48）显著降低，SPID48的平均差异分别为48.4（P<0.0001）和29.3（P=0.0002）；但与羟考酮/对乙酰氨基酚（HB/APAP）组合相比，VX-548组SPID48的改善没有达到优效标准。VX-548总体耐受性良好。4.新型反义RNA疗法治疗DMD的Ⅱ期临床积极。Sarepta公司多肽磷酰二胺吗啉寡聚体（PPMO）疗法SRP-5051（vesleteplirsen）治疗适于使用外显子51跳跃治疗的杜氏肌营养不良（DMD）患者的国际Ⅱ期临床MOMENTUM（SRP-5051-201研究）结果积极。在28周时，SRP-5051（30mg/kg，每4周一次）可使抗肌萎缩蛋白的平均表达水平达到5.17%（较基线提高4.53%，P<0.0001）；平均外显子跳跃率达到11.11%（较基线提高10.07%）。此外，患者在预防性地接受补充镁治疗后，未发生与治疗相关的停药。5.SLC6A19别构抑制剂PKU早期临床积极。Jnana公司靶向苯丙氨酸（Phe）转运蛋白SLC6A19的潜在“first-in-class”小分子抑制剂JNT-517，在治疗苯丙酮尿症（PKU）患者的Ⅰ期临床获积极结果。与安慰剂相比，JNT-517组第28天患者的平均血液Phe水平显著降低51%（p=0.0019）；患者临床应答率达到88%；药物安全性良好。Jnana计划在今年下半年与监管机构沟通，寻求明年直接将JNT-517推进至关键Ⅲ期临床。6.赛诺菲布局IL-10R激动剂。赛诺菲宣布与Synthekine公司达成合作许可协议，获得后者专有蛋白质工程平台优化的多种IL-10R激动剂的临床前、开发和商业化权益，用于治疗炎症性疾病。工程化蛋白分子可选择性地激活特定细胞上的细胞因子信号传导，从而最大限度地提高疗效并降低毒性。根据协议，Synthekine将获得4000万美元的预付款，临床前、开发、监管和商业里程碑潜在付款，以及产品的分级特许权使用费。7.司美格鲁肽2023年大卖212亿美元。1月31日，诺和诺德发布2023年Q4及全年业绩。2023年总销售额为2322.61亿丹麦克朗（约337.01亿美元），同比增长31%。司美格鲁肽全年总销售额达到约211.58 亿美元：司美格鲁肽注射液Ozempic（2型糖尿病）收入957.18亿丹麦克朗（139.17亿美元，+60%）；司美格鲁肽片剂Rybelsus（2型糖尿病）收入187.50亿丹麦克朗（27.26亿美元，+66%）；司美格鲁肽注射液Wegovy（肥胖）收入313.43亿丹麦克朗（45.57亿美元，+407%）。医药热点1.南京鼓楼医院互联网医院服务再升级。近日，南京鼓楼医院互联网医院线上复诊医保在线支付开通，旨在解决患者因时间、空间无法到线下医院复诊开药的问题，同时医保报销节省看病费用。患者授权医保电子凭证后，即可享受“在线复诊—续方开药、开检查—医保支付—药品配送”的一体化医疗服务，线上复诊的挂号费及后续药费、检查费均可医保线上支付，切实给患者带来便利。2.浙江报告1例H3N2与H10N5混合感染死亡病例。据国家疾控局30日通报，浙江省发现一例H3N2与H10N5混合感染病例。患者，女，63岁，安徽宣城人，既往有多种基础性疾病。2023年11月30日出现咳嗽、咽痛、发热等症状；12月2日因病情加重收入当地医疗机构救治；12月7日，转至浙江省医疗机构住院治疗，后因病情严重于12月16日死亡。专家评估认为，此次疫情为一次偶发的禽到人的跨种属传播。该病毒感染人的风险低，未发生人传人的情况。评审动态  1. CDE新药受理情况（01月31日) 2. FDA新药获批情况（北美01月29日）股市资讯上个交易日 A 股医药板块 -4.66%涨幅前三     跌幅前三欧康医药+2.48%  之江生物-10.54%赛托生物+2.10%  景峰医药-10.12%健友股份+1.96%  海正药业-10.04%[荣丰控股]预计2023年年度实现归居于上市公司股东的净利润亏损2300万元-3700万元，同比增长39.36%-2.46%;扣除非经常性损益后的净利润亏损3186万元-4586万元，同比增长61.77%-44.97%;营业收入1.1亿元-1.2亿元。[片仔癀]预计2024年第一季度，公司可实现归属于上市公司股东的净利润同比增长不低于25%。[华东医药]发布业绩预告，预计2023年年度实现归属于上市公司股东的净利润盈利28.12亿元-28.62亿元，同比增长12.50%-14.50%;归属于上市公司股东的扣除非经常性损益后的净利润盈利27.35亿元-27.84亿元，同比增长13.50%-15.50%。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。

▎药明康德内容团队编辑1月31日，科笛集团宣布，该公司的CU-40102（外用非那雄胺喷雾剂）新药上市申请（NDA）获得中国国家药监局药品审评中心（CDE）受理，适应症为治疗雄激素性脱发。截图来源：CDE官网雄激素性脱发（AGA）是常见的脱发类型，严重影响患者的心理健康和生活质量。该疾病一般认为与遗传因素及雄激素——二氢睾酮有关，但脱发的详细机制尚不十分清楚。非那雄胺作为特异性II型5α-还原酶竞争抑制剂，通过抑制头皮中睾酮转化为双氢睾酮，可治疗男性患者的雄激素性脱发。CU-40102是科笛集团自Polichem公司授权引进的一款用于雄激素性脱发治疗的外用非那雄胺产品。根据科笛集团新闻稿介绍，与口服非那雄胺不同，CU-40102的外用制剂便于患者将药物直接精确地涂抹在头皮表面，在用药部位保持高浓度，减少药物的全身暴露，从而可减少口服药常会引起的副作用。CU-40102的中国3期注册性临床试验是一项多中心、随机、双盲、安慰剂对照的试验，评估了该产品对中国成年男性雄激素性脱发患者的疗效及安全性。该临床试验共入组270名中国成年男性雄激素性脱发受试者。受试者在24周的持续治疗期内每天在头皮局部外用给药一次。该临床试验结果显示，在疗效方面，受试者在治疗24周后，CU-40102组受试者的顶部秃发目标区域内的总毛发计数及终毛计数改善均显著优于安慰剂组，差异具有统计学意义（P<0.05），达到主要终点指标和主要的次要终点指标，且疗效从第12周起开始展现。此外，基于研究者评估的顶部毛发评分的有效率，24周治疗后CU-40102组显著优于安慰剂组，且差异具有统计学意义。安全性方面，CU-40102受试者对给药部位局部耐受性良好，CU-40102组与安慰剂组不良事件的总体发生率相似，没有发生严重不良事件(TESAE)，及没有导致死亡的不良事件(TEAE)。与此同时，同期进行的一项CU-40102在中国成年男性雄激素性脱发患者中的1期药代动力学研究显示，非那雄胺喷雾剂给药后，中国雄激素性脱发患者群全身吸收量极少。聚焦前沿，群星璀璨！JPM大会期间于旧金山举行的“2024药明康德全球论坛”上，数千名行业人士齐聚现场，30多位行业领袖带来独家洞见。为了更多行业同仁能够跨越时空观看精彩内容，北京时间2月1日10:00-14:30，我们将提供“2024药明康德全球论坛”限时免费线上回放。产业大咖为何对2024年保持乐观？GLP-1激动剂的火热给我们带来了哪些启示？在癌症和更广泛的疾病领域，新兴疗法将如何重塑治疗格局？还有哪些技术和方向可能在新一年里迎来爆发？欢迎扫描结尾二维码查看完整议程并注册预约观看！▲本次论坛面向全球观众免费开放，长按识别上方二维码，即可申请观看。参考资料：[1] CU-40102（外用非那雄胺喷雾剂）新药上市申请获得国家药品监督管理局受理. Retrieved Jan 31 , 2024, from https://mp.weixin.qq.com/s/ctoKV8jXKDy-zKi7qP4Sag[2]CU-40102（外用非那雄胺喷雾剂）及CU-10201（外用4%米诺环素泡沫剂）III期临床试验结果在第18届CDA年会发布. Retrieved Dec 11, 2023, from https://mp.weixin.qq.com/s/LXPrI2Ndepnz9YN7SND4Lw本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈。转发授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

Topical terbinafine has been widely used in other markets to treat fungal nail infections If and when approved, the product will enter the topical fungicides market that is estimated to be C$88 million on an annual basis* Toronto, Ontario and Chicago, Illinois--(News - January 8, 2024) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced that Health Canada recently accepted for review Medexus's new drug submission, or NDS, for terbinafine hydrochloride nail lacquer to treat fungal nail infections. "Health Canada's commitment to review our NDS brings us a step closer to making topical terbinafine a viable treatment option for Canadians," said Richard Labelle, Medexus's General Manager-Canadian Operations. "Topical terbinafine is an excellent strategic fit for our leading allergy/dermatology business, and we look forward to putting our institutional knowledge to work as we target a commercial launch in the first half of calendar year 2025." Topical terbinafine has been widely used in other markets to treat fungal nail infections. Medexus's NDS for topical terbinafine seeks Health Canada approval for a distinctive once-a week treatment regimen. If and when approved, the product will enter the Canadian topical fungicides market that is estimated to be C$88 million on an annual basis.* * Source: IQVIA Canadian drugstore and hospital purchases, September 2023 MAT. About Medexus Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus's current focus is on the therapeutic areas of oncology, hematology, rheumatology, auto-immune diseases, allergy, and dermatology. For more information about Medexus and its product portfolio, please see the company's corporate website at and its filings on SEDAR+ at Contacts Ken d'Entremont | CEO, Medexus Pharmaceuticals Tel: 905-676-0003 | Email: ken.dentremont@medexus.com Marcel Konrad | CFO, Medexus Pharmaceuticals Tel: 312-548-3139 | Email: marcel.konrad@medexus.com Forward-looking statements Certain statements made in this news release contain forward-looking information within the meaning of applicable securities laws, also known and/or referred to as "forward-looking information" or "forward-looking statements". The words "anticipates", "believes", "expects", "will", "plans", "potential", and similar words, phrases, or expressions are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words, phrases, or expressions. Specific forward-looking statements contained in this news release include, but are not limited to, statements regarding the potential benefits of terbinafine hydrochloride; the occurrence, timing, and expected outcome of the Health Canada review process for the NDS for terbinafine hydrochloride discussed in this news release; if approved by Health Canada, the expected timing of any commercial launch of terbinafine hydrochloride discussed in this news release in Canada and related expectations regarding the product's prospects; and the potential competitive position of terbinafine hydrochloride discussed in this news release and anticipated trends and potential challenges in the market in which the product is expected to compete. These statements are based on factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, including assumptions based on historical trends, current conditions, and expected future developments. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. Medexus cautions that, although the assumptions are believed to be reasonable in the circumstances, these risks and uncertainties mean that actual results may differ, and may differ materially, from the expectations contemplated by the forward-looking statements. Material risk factors include, but are not limited to, those set out in Medexus's materials filed with the Canadian securities regulatory authorities from time to time, including Medexus's most recent annual information form and management's discussion and analysis. In addition, specific risks and uncertainties relevant to the content of this news release include, among other things, the uncertainties inherent in research initiatives and regulatory review processes, including the possibility of unfavorable new data and further analyses of existing data; the risk that data and regulatory submissions are subject to differing interpretations and assessments by regulatory authorities and/or other relevant third parties; and whether regulatory authorities and/or other relevant third parties will be satisfied with the design and methodology of and results from relevant studies and/or the content of relevant regulatory submissions, all of which will depend on many factors, including determinations as to whether the product's benefits outweigh its known risks. Accordingly, undue reliance should not be placed on these forward-looking statements, which are made only as of the date of this news release. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise. Additional notes Terbinafine hydrochloride nail lacquer, as discussed in this news release, is not approved by Health Canada for sale and use in Canada. Medexus makes no representation that terbinafine hydrochloride is appropriate for, or authorized for sale to or use by, persons who are located either in or outside Canada. Terbinafine hydrochloride is currently the subject of a regulatory review process with Health Canada. Medexus holds exclusive commercialization rights to terbinafine hydrochloride nail lacquer supplied by Polichem, an Almirall group company focused on medical dermatological treatments for skin health, in Canada. The information in this news release is provided for informational purposes to investors in Medexus securities. To view the source version of this press release, please visit