Boryung Corp.

Pfizer's first wave of PD-1xVEGF trials, Akeso's first overall survival win from ivonescimab and more deals from Eli Lilly made our news this week. Pfizer is launching the first clinical trials for its PD-1xVEGF drug, while Akeso detailed the first overall survival win for its first-in-class ivonescimab. Eli Lilly signed two more drug discovery pacts, continuing a dealmaking spree. And more.1. With Summit leading the pack in PD-1xVEGF bispecifics, Pfizer lays out its own plan to replace KeytrudaPfizer unveiled the first clinical trials for its PD-1xVEGF bispecific licensed from China’s 3SBio. One of the first two phase 3 trials is a head-to-head study against Keytruda in the two drugs’ respective combinations with chemotherapy in patients with first-line non-small cell lung cancer. A phase 1/2 will combine the drug, coded PF-08634404, with Pfizer’s antibody-drug conjugates.2. Akeso details ivonescimab's 1st overall survival win. Should Summit celebrate?Akeso provided detailed results for ivonescimab’s first positive overall survival readout, showing that the addition of the PD-1xVEGF drug to chemotherapy reduced the risk of death by 25% in Chinese patients with previously treated EGFR-mutated NSCLC. The OS win marked another validation of the drug class but did not necessarily secure ivonescimab a top spot in this particular indication.3. Eli Lilly pens $1.2B pact with Sanegene to better target metabolic RNA medsLilly continues AI push, inking $100M-plus research pact with InsilicoEli Lilly continued its recent deal spree by inking a research pact worth up to $1.2 billion with Sino-American biotech SanegeneBio focused on cardiometabolic RNA interference medicines and a separate $100 million-plus deal with artificial intelligence drug discovery outfit Insilico Medicine. The Indianapolis pharma had just signed another AI drug design deal with XtalPi last week.4. Neurocrine's depression drug is latest asset from Takeda pact to flunk a phase 2 trialA phase 2 major depressive disorder trial of a candidate Neurocrine Biosciences licensed from Takeda has failed. The drug, a negative allosteric modulator of the NMDA NR2B receptor, failed to beat placebo on change in depression severity by Day 5 as measured on the Montgomery-Åsberg Depression Rating Scale.5. Lyell hands over $70M-plus in cash, equity for 'impressive' phase 1-stage colorectal cancer CAR-TLyell Immunopharma is paying Sino-American firm Innovative Cellular Therapeutics $40 million upfront, plus 1.9 million of its own shares, for ex-China rights to a CAR-T therapy. In an ongoing U.S. study in 12 pretreated colorectal cancer patients, a high dose of the guanylyl cyclase-C-targeted CAR-T has shown a 67% overall response rate and median progression-free survival of 7.8 months.6. Third Arc Bio pens back-loaded $840M pact for Adagene's masking T-cell engager techIn a heavily back-loaded deal, Third Arc Bio is tapping Adagene to develop T-cell engagers against tumor-associated antigens. The pact includes $5 million upfront and up to $840 million in milestones. The Adagene platform involved is designed to activate an antigen when it reaches the tumor microenvironment, improving safety and widening therapeutic index.Other News of Note:7. JSF divests CRO Crown Biosciences for $204M (release, release)8. Recall roundup: Fresenius, Sun and Teva among drugmakers pulling products in recent weeks9. Lundbeck, Otsuka back survey uncovering ‘blind spot’ around Alzheimer’s agitation10. Boryung breaks ground on penicillin plant expansion in South Korea11. China allocates $60M to procure 15.4M bivalent HPV shots for national immunization scheme (Jiemian, Chinese)

South Korea’s Boryung Corporation continues to boost its production footprint by kicking off a project that will double the size and capacity of its penicillin manufacturing facility. South Korea’s Boryung Corporation continues to boost its production footprint by kicking off a project that will double the capacity of its penicillin manufacturing facility in its home country.The project will expand Boryung’s oral penicillin antibiotic production line at its campus in Ansan, South Korea, from 2,777 square meters (nearly 29,000 square feet) to 4,364 square meters (nearly 47,000 square feet) when completed. The cost of the expansion wasn’t disclosed.The expansion works to fulfill a government directive that designated oral penicillin as an essential drug in the wake of supply chain problems that occurred during and after the COVID-19 pandemic. Historically, Boryung has accounted for more than 60% of domestic contract manufacturing of penicillin, the company said in a Nov. 12 press release.“This expansion represents a meaningful step forward in elevating the production quality and supply capacity of penicillin antibiotics, a national essential treatment,” Jay Kim, Boryung chair and chief executive, said in a statement. “Boryung will continue to strengthen the stability of the essential treatment supply chain and fulfill its responsibility as a company dedicated to protecting public health.”The expansion will introduce new systems and equipment, including automated packaging systems and other process innovation technologies. Boryung first revealed plans to expand the penicillin plant two months ago. In September, Boryung struck a deal with Sanofi worth up to $205 million to gain rights to produce and sell the French pharma's chemotherapy Taxotere (docetaxel) for nearly 20 markets. Taxotere, which was first approved in the 1990s, is designated by the World Health Organization as an essential medicine for the treatment of early-stage and metastatic breast cancer as well as metastatic prostate cancer.Taxotere hauled in about $82 million for Sanofi last year, down significantly from the peak of $3 billion annually before its U.S. patent expired in 2010.

☝ 点击上方 一键预约 ☝   最新最热的医药健康新闻政策 十一假期前夕，药企赴港上市再度掀起一波小高潮。仅9月29日、30日两天，就有8家公司向港交所递表，其中既有资本市场的老兵，也有刚登陆A股不久的新秀。 9月29日，已在A股挂牌近9年的贝达药业向港交所递交主板上市申请，正式拉开“抢滩H股”序幕。贝达药业已有八款药品上市销售，其中，埃克替尼和恩沙替尼是肺癌市场响当当的品种。据悉此次，公司将拟借港股市场加速全球化布局。 另外，微医早在2021年和2024年微医就已曾递表港交所，但都未能实现上市。如今，微医选择再闯港交所。据弗若斯特沙利文的资料，按2024年收入计，微医在中国数字健康服务市场（不包括药品销售）及AI医疗健康解决方案市场均排名第一。此外，还有百利天恒、长春高新、麦科奥特、蓝纳成、华恒生物等，都在港股市场排起了长队。 更多资讯，整理如下： 重磅政策一览  1、异常数据引发的医保基金飞行检查 9月29日，国家医保局发布《异常数据引发的医保基金飞行检查》，揭露了“神秘未知医生大量开药”、“高龄老人开展辅助生殖”、“批量开方暴露问题线索”、“男病女治触发逻辑矛盾”背后真相。 医保基金监管数据分析发现，某医生在一分钟内为不同病人开具多份司美格鲁肽处方。该医生明知患者冒名就医，仍长期配合为其开具诊断为糖尿病、二甲双胍用药疗效不佳、建议使用司美格鲁肽的门诊复诊处方。经飞检核查后，医保部门对该医生作出暂停延聘程序、待岗培训和扣罚个人绩效等措施。涉嫌违法问题已移交相关部门进一步查处。 全国统一的医保信息平台已经可以精准定位异常数据，国家医保局能做到发现一起、查处一起、整改一起，医保数据对监管的赋能作用持续凸显。大数据时代，任何违法违规行为都难逃“数据慧眼”。 2、临床急需药品进口提速 9月30日，国家药监局发布《关于境外已上市药品获批前商业规模批次产品进口有关事宜的公告》明确，境外已上市药品在我国获批上市，包括含取得药品批准证明文件、取得补充申请批准证明文件的，对符合要求的获批前商业规模批次产品，允许进口并上市销售。 适用药品类别共有6种情形，包括原研药品、改良型药品，短缺药品、罕见病治疗用药等临床急需药品，以及适用《药品注册管理办法》药品加快上市注册程序在我国获批上市的药品。 一款进口药品从在中国获批上市到投放市场，中间需经过生产、运输、通关、进口检验等环节，实际投放时间平均需5-7个月。《公告》允许药品获批前的商业规模批次产品进口并上市销售，企业可以更早启动进口程序，实际上缩短了药品供应我国市场的用时。 医药卫生事件 1、白云山旗下基金入股南京医药 9月28日，白云山发布公告称，白云山旗下广药二期基金拟出资7.49亿元收购Alliance Healthcare AsiaPacific Limited持有的南京医药1.45亿股非限售股份，占南京医药总股份数的11.04%。收购完成后，广药二期基金拟将成为南京医药第二大股东。 广药二期基金是白云山出资14.99亿元参与设立的私募股权投资基金，白云山出资比例99.90%。 白云山和南京医药的核心业务都是医药流通，南京医药一直是江苏省医药流通业领军企业，主营业务聚焦医药批发和医药零售业务，其医药批发业务在江苏、安徽、福建、湖北等区域优势明显。9月28日，白云山、广药二期基金还与南京医药也签署了战略投资协议，开展资本合作、自有工业品种分销渠道合作、中医药领域合作。 2、赛诺菲出售王牌抗癌药 9月30日，韩国保宁制药宣布：和赛诺菲签署资产收购协议，以约合人民币14.6亿元的价格收购赛诺菲经典抗肿瘤药物多西他赛注射液的全球业务权益。 多西他赛注射液是一种紫杉烷类抗肿瘤药物，是临床重要的化疗药物之一，广泛用于乳腺癌、非小细胞肺癌、前列腺癌等实体瘤治疗。尽管其专利已到期，但仍然是癌症治疗领域的重要药物，2024年，该药的全球销售额约合人民币5.6亿元。 3、多家企业赴港递交上市申请 9月29日-9月30日，多家上市药企集中公告了拟赴港上市的计划。除了已上市的百利天恒、微医、长春高新、贝达药业，还有一批创新Biotech，也在抢占IPO热潮窗口期。 百利天恒拥有全球首创且唯一进入临床III期开发阶段的EGFR×HER3双抗ADC，以及迄今为止全球首创且唯一进入临床开发阶段的四个多特异性抗体，基于ADC平台优势，已开发出一款全球潜在FIC的ARC药物。 滨会生物成立于2001年，为一家溶瘤病毒疗法公司，其首发管线BS001已经进入临床三期阶段，有望成为全球首款HSV-2溶瘤病毒疗法。2023年12月，完成2000万元最新一轮融资，投后估值32.2亿元。 合成生物学企业华恒生物；东诚药业旗下聚焦创新核药研发的核心子公司蓝纳成生物；专注代谢性疾病的平台型生物技术公司麦科奥特，都已向港交所提交了IPO申请。 4、武田退出细胞治疗 10月1日，日本武田制药正式宣布退出细胞治疗领域，这一决策被纳入其“战略资产组合重新排序”计划。从资产清单来看，截至今年7月30日，武田的4款肿瘤资产中已无细胞治疗产品身影。 武田的退出并非孤立事件，而是当前细胞治疗行业周期的一个缩影。就在武田宣布退出的前一天，诺和诺德因正在进行的重组计划，终止了一项价值5.98亿美元的心血管细胞治疗合作协议。 一周药械盘点 1、首个国产四价HPV疫苗获批上市 9月28日，中国生物官微显示，国药集团中国生物成都生物制品研究所和中国生物研究院联合申报的四价重组人乳头瘤病毒疫苗“汉逊酵母”获批上市，用于18-45岁女性进行预防性接种，是我国第一款国产四价HPV疫苗。 此前，国内已获批上市的四价HPV疫苗主要来自默沙东。该疫苗由中国生物研究院自主研发，成都生物制品研究所进行产业化开发，双方共同开展临床研究。 (来源：健识局 作者：苗苗 ） 药闻康策 新媒体矩阵微信公众号 点击下方  一键关注 【免责声明】 1.“药闻康策”部分文章信息来源于网络转载是出于传递更多信息之目的，并不意味着赞同其观点或证实其内容的真实性。如对内容有疑议，请及时与我司联系。2.“药闻康策”致力于提供合理、准确、完整的资讯信息，但不保证信息的合理性、准确性和完整性，且不对因信息的不合理、不准确或遗漏导致的任何损失或损害承担责任。3.“药闻康策”所有信息仅供参考，不做任何商业交易或医疗服务的根据，如自行使用“药闻康策”内容发生偏差，我司不承担任何责任，包括但不限于法律责任，赔偿责任。 欢迎转发分享、点赞、点在看