Kwangdong Pharmaceutical Co., Ltd.

药·械 追踪Products NewsNo.1 /强生埃万妥单抗、拉泽替尼上市申请获NMPA受理根据国家药监局药审中心（CDE）数据，强生旗下埃万妥单抗和兰泽替尼上市申请获国家药监局受理。埃万妥单抗是一种直接针对EGF受体和MET受体的双特异性抗体，此次是埃万妥单抗提交的第三项适应证上市申请。拉泽替尼是韩国柳韩洋行研发的第三代EGFR-TKI，韩国之外的权益已转让给美国强生。2023年12月，强生已向美国FDA提交埃万妥单抗联合拉泽替尼用于一线治疗EGFR外显子19缺失或L858R替代突变的局部晚期或转移性非小细胞肺癌（NSCLC）的上市申请。->点击阅读原文，解锁完整双语新闻企业动态Companies NewsNo.1 /66.52亿元！迈瑞医疗收购惠泰医疗21.12%股份迈瑞医疗近日发布公告称，公司拟通过全资子公司深迈控以协议转让方式收购惠泰医疗21.12%股份，转让金额合计为约66.52亿元；同时，深迈控拟受让晨壹红启持有的珠海彤昇全部0.12%的普通合伙权益。交易完成后，深迈控及其一致行动人珠海彤昇合计持有惠泰医疗24.61%股份，惠泰医疗控股股东将变更为深迈控。->点击阅读原文，解锁完整双语新闻No.2 /兆科眼科将老花眼缩瞳药BRIMOCHOL PF韩国分销权授予KDP兆科眼科日前宣布，与韩国Kwangdong Pharmaceutical Co., Ltd.（简称“KDP”）就BRIMOCHOL PF（卡巴可2.75%/酒石酸溴莫尼丁0.1%固定剂量复方）不含防腐剂外用滴眼液签订分销及供应协议。根据协议条款，兆科眼科将BRIMOCHOL PF在韩国的独家分销权授予KDP；KDP将代表兆科眼科在韩国进行药品注册，并独家进口、推广、分销、营销及销售该产品。->点击阅读原文，解锁完整双语新闻No.3 /健康元获得荃信生物、博安生物IL-4Rα抗体BA2101中国大陆权益近期，健康元药业集团股份有限公司（以下简称“健康元”）与江苏荃信生物医药股份有限公司联合宣布，双方就QX008N单抗达成战略合作并签署中国大陆及香港、澳门特别行政区的独占许可协议。博安生物也宣布，与健康元就抗IL-4Rα长效单抗BA2101注射液用于治疗哮喘和慢性阻塞性肺疾病（COPD）等呼吸系统疾病的中国大陆独家权利达成合作。->点击阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力 关于 G B I”自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20年的深耕细作，GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作▶ sylvia.hua@generalbiologic.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

Dry Eye Disease (DED): PL9643 MELODY-1 Phase 3 Study Data Base Lock 2H January 2024 Topline Data Readout Expected Early 1Q Calendar Year 2024 Ulcerative Colitis (UC): Oral PL8177 Phase 2 Clinical Study in Active UC Patients Interim Analysis Data Readout on Track for 1Q Calendar Year 2024 Topline Results Expected in 2Q Calendar Year 2024 Obesity: Melanocortin Receptor 4 (MCR4) Agonist + Glucagon Like Peptide-1 (GLP-1) Phase 2 Clinical Study Targeted to Start 1Q Calendar Year 2024 Topline Results Expected in 2H Calendar Year 2024 Male Sexual Dysfunction: Bremelanotide Co-Formulated with a PDE5i for the Treatment of Erectile Dysfunction (ED) in Patients that do not Respond to PDE5i Monotherapy Phase 2 Clinical Study Targeted to Start 1Q Calendar Year 2024 Topline Results Expected in 2H Calendar Year 2024 Vyleesi® Completed Asset Sale to Cosette Pharmaceuticals for up to $171 Million $12 Million Upfront Plus Sales-Based Milestones of up to $159 Million CRANBURY, N.J., Jan. 8, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today provided a corporate update, highlighted the Company's key calendar year 2023 accomplishments and outlined its anticipated calendar year 2024 clinical development milestones. "We made significant operational progress during calendar year 2023 and we believe we are well-positioned for making calendar year 2024 a pivotal and transformative year for Palatin," said Carl Spana, Ph.D., President and CEO of Palatin. "Our internal research and development efforts are focused in areas where we believe we have a high probability of success, product differentiation and the opportunity for a substantial return on our investment. Topline data readout for our Phase 3 PL9643 clinical study for DED is expected early in the first quarter of calendar year 2024. Our Phase 2 study of oral PL8177 in patients with UC is expected to have an interim analysis data readout in the first quarter and topline trial results in the second quarter of calendar year 2024." Dr. Spana further commented, "We are excited by the significant opportunity of melanocortin-based therapeutics for obesity treatment and believe we are well positioned to deliver selective and efficacious MCR4 long-acting peptides and orally active small molecules. We expect to commence a Phase 2 clinical study of a MCR4 agonist plus a GLP-1 in obese patients in the first quarter of calendar year 2024. In addition, following on our significant expertise in product development to treat sexual dysfunction, we expect to commence a Phase 2 clinical study evaluating bremelanotide co-formulated with a PDE5i for the treatment of ED in patients that do not respond to PDE5i monotherapy in the first quarter of calendar year 2024." The recently announced divestiture of Vyleesi is consistent with Palatin's strategic decision to concentrate on its robust development and clinical pipeline. Palatin is now focused on developing novel therapeutics that modulate the melanocortin receptor system. Program Updates and Expected Milestones for 2024 Anti-Inflammatory / Autoimmune Programs PL9643 melanocortin agonist Phase 3 study for the treatment of DED: Patient enrollment completed (n=570) in Phase 3 MELODY-1 study Data base lock second half of January 2024 Topline data readout expected early first quarter of calendar year 2024 Phase 3 safety and efficacy study MELODY-2 and the open label MELODY-3 study are anticipated to commence patient enrollment in the second half of calendar year 2024 PL8177 oral melanocortin agonist Phase 2 study for the treatment of UC: Interim assessment targeted for the first quarter of calendar year 2024 Topline data readout is expected in the second quarter of calendar year 2024 Bremelanotide BREAKOUT Phase 2 study in patients with diabetic kidney disease: Topline data readout is expected in the second quarter of calendar year 2024 Metabolic Program (Obesity) Presented positive data with bremelanotide, a melanocortin receptor 4 (MCR4) agonist, plus glucagon like peptide-1 (GLP-1) showing increased weight loss and greater glucose control above monotherapy: Phase 2 clinical study targeted to start in the first quarter of calendar year 2024 Topline data readout is expected in the second half of calendar year 2024 Initiation of investigational new drug (IND) enabling activities for a novel MCR4 selective long-acting agonist expected in the second half of calendar year 2024 Sexual Health Program (Male Sexual Dysfunction) Initiated a clinical development program evaluating bremelanotide co-formulated with a PDE5 inhibitor (PDE5i), for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy: Phase 2 clinical study in PDE5i non-responder ED patients is expected to commence in the first quarter of calendar year 2024 Topline data readout is expected in the second half of calendar year 2024 Vyleesi® (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD) Completed asset sale to Cosette Pharmaceuticals for up to $171 million in December 2023 for female HSDD: $12 million upfront, plus potential sales-based milestones of up to $159 million based on annual net sales ranging from $15 million to $200 million Eligible to receive regulatory approval milestones of $10.5 million related to Fosun ($7.5M China) and Kwangdong ($3.0M S. Korea) licenses – Kwangdong completed a required Phase 3 study in HSDD patients and is preparing a regulatory approval submission Palatin retained rights and use of bremelanotide for obesity and male erectile dysfunction indications About Melanocortin Receptor Agonists and Inflammation The melanocortin receptor ("MCr") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1r through MC5r. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects. Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation. About Palatin Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. To learn more about Palatin, please visit us on and follow us on Twitter at @PalatinTech. Forward-looking Statements Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about Palatin products in development, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, and market potential for product candidates are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory agencies and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating events that occur after the date of this press release. Palatin Technologies® is a registered trademark of Palatin Technologies, Inc. SOURCE Palatin Technologies, Inc.

Palatin to receive $12 million upfront, plus sales-based milestones of up to $159 million Palatin's focus is solely on its development and clinical pipeline based on the melanocortin receptor system CRANBURY, N.J., Dec. 20, 2023 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced the sale of Vyleesi® to Cosette Pharmaceuticals, a US-based, speciality pharmaceutical company, for up to $171 million, consisting of an upfront purchase price of $12 million plus contingent, sales-based milestone payments of up to $159 million. Vyleesi is the first and only as-needed treatment approved by the Food and Drug Administration (FDA) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). "The divestiture of Vyleesi is consistent with our strategic decision to concentrate on our robust development and clinical pipeline," stated Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "Our focus now is solely on developing novel therapeutics that modulate the melanocortin receptor system. Our Phase 3 PL9643 clinical study for dry eye disease has completed patient enrollment and treatment, and we look forward to the availability of topline data results in the near future. Our Phase 2 study of oral PL8177 in patients with ulcerative colitis is expected to have an interim analysis readout in the first quarter and topline trial results in the second quarter of calendar year 2024." "Vyleesi is an important product for the millions of women suffering from HSDD. Cosette is committed to women's healthcare, and we are pleased they will make Vyleesi a priority in their current product portfolio," concluded Dr. Spana. "Vyleesi is an important addition to our rapidly expanding women's health platform," said Apurva Saraf, President and Chief Executive Officer of Cosette. "HSDD is the most prevalent form of female sexual dysfunction, affecting approximately six million premenopausal women in the U.S. Through this acquisition, our mission is to give hope, support, and a safe and effective treatment option for millions of women." Under the terms of the asset purchase agreement with Cosette, Palatin will receive $12 million upfront. Palatin is also eligible to receive up to $159 million contingent upon the achievement of sales milestones ranging from annual net sales of $15 million to $200 million. Palatin will transfer to Cosette all information, data, and assets related exclusively to Vyleesi. Palatin will provide certain transitional services to Cosette for a period of time to ensure continued patient access to Vyleesi while Vyleesi is operationally separated from Palatin. Cosette will reimburse Palatin for the costs of the transition services. Palatin is also eligible to receive regulatory approval milestones of $10.5 million associated with the previous licensing of Vyleesi, consisting of $7.5 million related to Fosun for China and $3.0 million related to Kwangdong for S. Korea. About Cosette Pharmaceuticals, Inc, Cosette Pharmaceuticals, Inc. ("Cosette") is a US-based, fully integrated pharmaceutical company with a fast-growing portfolio of branded pharmaceuticals consisting of products in women's health, cardiology and dermatology. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by 300+ dedicated employees across all functional areas. Cosette is backed by Avista Capital Partners, a healthcare focused private equity firm. . About Palatin Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at and follow Palatin on Twitter at @PalatinTech. Forward-looking Statements Statements in this press release that are not historical facts, including statements about future expectations of Palatin, such as statements about Vyleesi results and potential market, are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating events that occur after the date of this press release. Palatin Technologies® is a registered trademark of Palatin Technologies, Inc. Company Codes: AMEX:PTN