Mastodynia

乳腺癌是威胁女性健康的“粉红杀手”，关注乳腺健康，积极防治乳腺癌刻不容缓。每年10月是世界乳腺癌防治月，每年10月18日为防乳癌宣传日，我们一起共同守护乳腺健康，共筑粉红围墙。 早预防 世界卫生组织国际癌症研究机构（IARC）发布的2022年全球癌症数据显示： 全球乳腺癌发病人数约为229万，在所有肿瘤中占比高达11.5%。 我国乳腺癌为女性最常见的恶性肿瘤之一，新发病例数约为35.7万1。 避免吸烟、经常锻炼、保持健康体重、保持健康饮食习惯、安排年度乳腺检查等行为能够有效降低患癌风险。 早发现 乳腺癌可以通过影像学检查、乳腺自检、肿瘤标志物检查等方式进行筛查，以期及早发现、及早诊断。 一般推荐女性参加乳腺癌筛查的年龄为40岁，乳腺癌高危人群可提前进行筛查（小于40岁），筛查间期推荐每年1次。  乳腺癌高危人群（具有如下任一条件）： ● 有明显的乳腺癌遗传倾向者（满足以下任一条件）： （1）一级亲属有乳腺癌或卵巢癌史 （2）二级亲属50岁前患乳腺癌2人及以上 （3）二级亲属50岁前患卵巢癌2人及以上 （4）至少1位一级亲属携带已知BRCA1/2基因致病性突变；或自身携带BRCA1/2基因致病性突变 ● 既往诊断为乳腺不典型增生；或小叶原位癌 ● 既往30岁前接受过胸部放疗 ● 根据Gail模型计算未来5年罹患乳腺癌风险≥1.67%2 早治疗 乳腺癌最常见的症状；乳房肿块，还可能会出现乳头溢液、乳头回缩、乳房疼痛、皮肤改变等症状。 早期乳腺癌往往不具备典型的症状和体征，不易引起重视，常通过体检或乳腺癌筛查发现。 对于早期乳腺癌患者，如果确诊后进行及时干预，患者5年生存率可达80%-90%，因此，及早发现、及早治疗是关键3。 恒瑞医药多年来持续关注中国乳腺癌领域的治疗现状，在乳腺癌治疗探索上成果颇丰。中国首个自主研发的HER1/HER2/HER4靶向药物已获批3个乳腺癌相关适应症，全面覆盖HER2阳性乳腺癌领域晚期一线、晚期二线及新辅助治疗。在晚期一线的PHILA研究中，HER1/HER2/HER4靶向药物联合治疗组中位无进展生存期（mPFS）达到24.3个月，突破2年，该研究2023年10月底正式在线发表于国际四大顶级医学期刊之一——《英国医学杂志》（British Medical Journal，简称BMJ；影响因子：105.7）上，是当时乳腺癌领域中国自主研发药物刊登国际期刊影响因子最高的临床研究4。 CDK4/6抑制剂的出现改变了HR+/HER2-晚期乳腺癌的治疗格局。历时9年，由恒瑞自主研发的中国首个原研CDK4/6抑制剂获批上市，目前已获批上市2个乳腺癌相关适应症，涵盖了绝经前和绝经后HR+/HER2-晚期乳腺癌。其疗效和安全性均得到临床专家的广泛认可，为广大中国乳腺癌患者提供了适合她们的中国“达”案。 公司多款乳腺癌创新药物已纳入国家医保，为中国医生和乳腺癌患者提供了更多的治疗选择。此外，目前公司仍有多款不同作用机制的创新产品布局乳腺癌治疗领域，覆盖了乳腺癌各亚型及晚期、辅助、新辅助各疾病阶段，多个乳腺癌相关适应症已被国家药品监督管理局药品审评中心纳入突破性疗法认定。 未来，恒瑞医药将始终坚持以患者为中心，聚焦乳腺癌等多个肿瘤领域加强创新药研究与开发，力争研制出更多更好的乳腺癌防治新药，为广大患者带来新的治疗选择。 今年乳腺癌防治月期间，恒瑞医药还支持开展“与名医同行，关爱她健康”公益活动、乳腺癌患者科普教育活动等，敬请关注。 注： [1]世界卫生组织国际癌症研究机构(IARC). 《2022年全球最新癌症负担数据》https://gco.iarc.fr/today/home. [2] Gail模型主要针对西方人群开发，可作为罹患乳腺癌风险评估参考。Gail模型纳入了包括年龄，种族，初潮年龄，初产年龄，个人乳腺疾病史，乳腺癌家族史，和乳腺活检次数等在内的多个风险因子。若受试者5年内发病风验≥1.67%，则认为是高风险。2011年，Gail模型进行了亚太人样校正，本指南利用该更新模型估算风险值. [3] 中国抗癌协会（CACA）乳腺癌诊疗指南（2024年版）. [4] Ma F, Yan M, Li W, et al. Pyrotinib versus placebo in combination with trastuzumab and docetaxel as first line treatment in patients with HER2 positive metastatic breast cancer (PHILA): randomised, double blind, multicentre, phase 3 trial[J]. BMJ, 2023, 383: e076065. 内容来源：恒瑞 on call 排版：程梦真 责编：王玲 往期精选 |  研发创新  | 慢病创新里程碑！恒瑞首个自免创新药夫那奇珠单抗获批上市 恒瑞医药新突破！中国首个自研阿片类镇痛创新药富马酸泰吉利定获批上市 |  国际化  | 海外BD再传捷报！恒瑞医药GLP-1类创新药组合实现海外许可 恒瑞医药与默克达成合作，携手推进癌症创新疗法 |  重磅奖项  | 喜报！恒瑞医药荣获2023年度国家科技进步奖 恒瑞医药连续六年入选全球制药企业50强榜单！ |  社会公益  | “健康中国行·重走长征路”项目启动仪式圆满举行！恒瑞提供公益支持，助力健康中国 恒瑞医药集团向中国扶贫基金会捐赠3000万设立“健康帮扶基金”

NEW YORK--( BUSINESS WIRE )--Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, announced it has received approval from the U.S. Food and Drug Administration (FDA) for the use of Motiva ® SmoothSilk ® Ergonomix ® and Motiva ® SmoothSilk ® Round breast implants in primary and revision breast augmentation. “ Today’s approval is transformative for breast aesthetics in the United States. This is a new era, in which women now have a choice of highly differentiated technology that is backed by rigorous scientific and clinical research,” commented Juan José Chacón-Quirós, Founder and Chief Executive Officer. “ Motiva implants have changed the paradigm by proving that women do not have to compromise when it comes to their aesthetic goals. We have never wavered in our commitment to women’s health and our entire organization is ready to bring this passion and technology to the United States.” Motiva ® SmoothSilk ® Round and Ergonomix ® Implants represent state of the art innovation in plastic surgery. These devices feature the patented SmoothSilk ® surface, designed for enhanced biocompatibility and scientifically shown to promote low inflammation. The Motiva ® SmoothSilk Ergonomix ® device is the first breast implant in the world that embodies the science of ergonomics, as it is designed to adapt, react, feel, and move like natural breast tissue. Motiva ® SmoothSilk ® Ergonomix ® implants are unique to the implant market, as their shape can adapt as the body changes position, maintaining a round shape when lying down and a teardrop shape when standing up. The Motiva ® SmoothSilk ® Round implants provide increased upper breast fullness and softness while keeping a round full form regardless of position. “ The Motiva U.S. IDE Study is the most rigorous breast implant clinical trial ever performed under FDA guidelines and it shows that Motiva implants are not only safe and effective but also that women had exceptional results, with less than one percent rates of capsular contracture and rupture in the primary augmentation cohort,” said board-certified plastic surgeon Dr. Caroline A. Glicksman. “ As the Medical Director of the Motiva study and an investigator, I am proud of the quality of the data and the patient follow-up rates of this study. Motiva implants were designed to reduce device related complications, and they will be welcomed by the plastic surgery community and women seeking breast augmentation in the United States.” The Motiva U.S. IDE Study was conducted at 32 centers in the U.S. and three centers in Western Europe. At the study endpoint of three years post-implantation, patient compliance in the primary augmentation cohort of the trial was 92.4%. The three-year, by-patient, Kaplan-Meier risk rates of first occurrence of complications for patients (95% confidence interval) in the primary augmentation cohort (N=451) were as follows: Capsular Contracture: 0.5%; Rupture, Confirmed or Suspected: 0.6% (MRI Cohort N=176); Breast Pain: 0.7%; Infection: 0.9%. Any reoperation, including an implant size change, was reported at 6.1% and any complication, including reoperations, was reported at 8.4%. “ There has been a real lack of innovation in the U.S. breast implant market for well over a decade,” added board-certified plastic surgeon and study investigator Dr. M. Bradley Calobrace. “ Motiva should transform breast augmentation, both in how we operate and in what we can achieve for our patients. A safer, next generation viscoelastic implant with a uniquely designed low inflammatory surface will undoubtedly improve clinical and aesthetic outcomes. I am pleased to finally be able to offer Motiva implants to my patients in the United States.” Since first becoming commercially available in 2010, nearly four million Motiva ® devices have been delivered to plastic and reconstructive surgeons in over 85 countries. The company’s technologies and products are covered by over 200 patent applications in 20 separate patent families worldwide and are supported by over 100 clinical and scientific studies and peer reviewed publications. The Motiva ® Implant approval announced today is the first new breast implant PMA approved by the U.S. FDA since 2013. “ Motiva is the first and only implant purposefully designed for women and their lifestyles,” said Dr. Kamakshi R. Zeidler, a board-certified plastic surgeon and member of the Establishment Labs Femtech Advisory Board. “ These implants move and feel like natural breast tissue. The rates of complications in the clinical trial were also much lower than we have seen with any other implant in a U.S. PMA study. This is true Femtech. I could not be happier that women in the United States now have access to this revolutionary technology.” About Establishment Labs Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving women’s health and wellness through the power of science, engineering, and technology. The Company offers a portfolio of Femtech solutions for breast health, breast aesthetics and breast reconstruction. The nearly four million Motiva ® devices Establishment Labs has delivered to plastic and reconstructive surgeons since 2010 have created a new standard for safety and patient satisfaction in the over 85 countries in which they are available. The Motiva Flora ® tissue expander is used to improve outcomes in breast reconstruction following breast cancer and it is the only regulatory-approved expander in the world with an integrated port using radio-frequency technology that is MRI conditional. Mia Femtech™, Establishment Lab’s unique minimally invasive experience for breast harmony, is the Company’s most recent breakthrough innovation. These solutions are supported by over 200 patent applications in 20 separate patent families worldwide and over 100 scientific and clinical studies and publications in peer reviewed journals. Establishment Labs manufactures at two facilities in Costa Rica compliant with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program. Please visit our website for additional information at www.establishmentlabs.com . Forward-Looking Statements This press 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 (the “Exchange Act”). You can find many (but not all) of these statements by looking for words such as “approximates,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “intends to,” “would,” “will,” “may” or other similar expressions in this press release. Any statements that refer to projections of our future financial or operating performance, anticipated trends in our business, our goals, strategies, focus and plans, including related product development and commercialization and regulatory approvals, and other characterizations of future events or circumstances, including statements expressing general optimism about future operating results, related to the company’s performance are forward-looking statements. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. We caution investors that any forward-looking statements presented in this report, or that we may make orally or in writing from time to time, are expressions of our beliefs and expectations based on currently available information at the time such statements are made. Such statements are based on assumptions, and the actual outcome will be affected by known and unknown risks, trends, uncertainties, and factors that are beyond our control. Although we believe that our assumptions are reasonable, we cannot guarantee future performance, and some will inevitably prove to be incorrect. As a result, our actual future results and the timing of events may differ from our expectations, and those differences may be material. Factors, among others, that could cause actual results and events to differ materially from those described in any forward-looking statements include risks and uncertainties relating to: our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product offerings; the rate of adoption of our products by healthcare providers or other customers; the success of our marketing initiatives; the safe and effective use of our products; our ability to protect our intellectual property; our future expansion plans and capital allocation; our ability to expand upon and/or secure sources of credit or capital; our ability to develop and maintain relationships with qualified suppliers to avoid a significant interruption in our supply chains; our ability to attract and retain key personnel; our ability to scale our operations to meet market demands; the effect on our business of existing and new regulatory requirements; and other economic and competitive factors. These and other factors that could cause or contribute to actual results differing materially from our expectations include, among others, those risks and uncertainties discussed in the company’s annual report on Form 10-K filed on March 4, 2024 and will be discussed in the company's quarterly report on Form 10-Q filed on August 7, 2024, which risks and uncertainties may be updated in the future in other filings made by the company with the Securities and Exchange Commission. The risks included in those documents are not exhaustive, and additional factors could adversely affect our business and financial performance. We operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for us to predict all such risk factors, nor can we assess the impact of all such risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. We are not undertaking any obligation to update any forward-looking statements. Accordingly, investors should use caution in relying on past forward-looking statements, which are based on known results and trends at the time they are made, to anticipate future results or trends.

NEW YORK--(BUSINESS WIRE)-- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, noted the presentation today of an update on the Motiva US IDE Study. The update will include four-year patient follow-up data for primary augmentation subjects. The Medical Director of the Study, Dr. Caroline Glicksman, who is also an Investigator in the Study, will present the results at The Aesthetic Meeting 2024 in Vancouver, BC Canada. Dr. Glicksman will present data for the 451 primary augmentation patients enrolled in the study through the four-year follow-up visit. Patient compliance in the primary augmentation cohort of the trial at four years was 88.9%. The four-year, by-patient, Kaplan-Meier risk rates of first occurrence of complications for patients (95% confidence interval) in the primary augmentation cohort were as follows: Primary Augmentation 4-year (N=451), 95% CI Capsular contracture (Baker Grade III/IV) 0.5% Rupture, suspected or confirmed; MRI cohort1 0.6% Breast pain 0.9% Infection 0.9% Implant removal, with or without replacement 1.8% Any reoperation2 6.8% Any complication3 9.6% 1. MRI cohort N=176 2. Any surgery on the breast or chest area, device or non-device related, including size change 3. Any device or non-device related event, including reoperation Commenting on the results, Dr. Glicksman said, “The consistency in these clinical results at four years is notable. Since we released the two-year data, we have seen no increase in capsular contracture or in the number of patients with suspected or confirmed rupture, including in the MRI cohort. Relative to historic benchmarks, patient follow-up remains very high and the rates of complication remain very low. The Motiva Implant PMA is under review by the FDA and we look forward to women in the United States having access to this new standard in breast implants very soon.” The Motiva Core pivotal study is an ongoing US clinical trial of an investigational medical device under an FDA-approved Investigational Device Exemption. Establishment Labs' Motiva silicone gel-filled implants are currently not approved for commercial distribution in the United States. This interim report describes preliminary data available to date and does not necessarily reflect final clinical results nor demonstrate the investigational device’s safety and effectiveness for the United States trial. Accordingly, no conclusions should be drawn based on the information presented. About Establishment Labs Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving women’s health and wellness through the power of science, engineering, and technology. The Company offers a portfolio of Femtech solutions for breast health, breast aesthetics and breast reconstruction. The over three million Motiva® devices Establishment Labs has delivered to plastic and reconstructive surgeons since 2010 have created a new standard for safety and patient satisfaction in the over 85 countries in which they are available. The Motiva Flora® tissue expander is used to improve outcomes in breast reconstruction following breast cancer and it is the only regulatory-approved expander in the world with an integrated port using radio-frequency technology that is MRI conditional. Mia Femtech™, Establishment Lab’s unique minimally invasive experience for breast harmony, is the Company’s most recent breakthrough innovation. These solutions are supported by over 200 patent applications in 25 separate patent families worldwide and over 50 scientific studies and publications in peer reviewed journals. Establishment Labs manufactures at two facilities in Costa Rica compliant with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program. In 2018, the Company received an investigational device exemption (IDE) from the FDA for Motiva Implants® and began a clinical trial to support regulatory approval in the United States. Please visit our website for additional information at . Forward-Looking Statements This press 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 (the “Exchange Act”). You can find many (but not all) of these statements by looking for words such as “approximates,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “intends to,” “would,” “will,” “may” or other similar expressions in this press release. Any statements that refer to projections of our future financial or operating performance, anticipated trends in our business, our goals, strategies, focus and plans, including related product development and commercialization and regulatory approvals, and other characterizations of future events or circumstances, including statements expressing general optimism about future operating results, related to the company’s performance are forward-looking statements. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. We caution investors that any forward-looking statements presented in this report, or that we may make orally or in writing from time to time, are expressions of our beliefs and expectations based on currently available information at the time such statements are made. Such statements are based on assumptions, and the actual outcome will be affected by known and unknown risks, trends, uncertainties, and factors that are beyond our control. Although we believe that our assumptions are reasonable, we cannot guarantee future performance, and some will inevitably prove to be incorrect. As a result, our actual future results and the timing of events may differ from our expectations, and those differences may be material. Factors, among others, that could cause actual results and events to differ materially from those described in any forward-looking statements include risks and uncertainties relating to: our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product offerings; the rate of adoption of our products by healthcare providers or other customers; the success of our marketing initiatives; the safe and effective use of our products; our ability to protect our intellectual property; our future expansion plans and capital allocation; our ability to expand upon and/or secure sources of credit or capital; our ability to develop and maintain relationships with qualified suppliers to avoid a significant interruption in our supply chains; our ability to attract and retain key personnel; our ability to scale our operations to meet market demands; the effect on our business of existing and new regulatory requirements; and other economic and competitive factors. These and other factors that could cause or contribute to actual results differing materially from our expectations include, among others, those risks and uncertainties discussed in the company’s annual report on Form 10-K filed on March 4, 2024, which risks and uncertainties may be updated in the future in other filings made by the company with the Securities and Exchange Commission. The risks included in those documents are not exhaustive, and additional factors could adversely affect our business and financial performance. We operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for us to predict all such risk factors, nor can we assess the impact of all such risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. We are not undertaking any obligation to update any forward-looking statements. Accordingly, investors should use caution in relying on past forward-looking statements, which are based on known results and trends at the time they are made, to anticipate future results or trends.