Lantus copy, CStone CEO and Novartis plant—FiercePharmaAsia
Ongoing improvements at Biocon's Malaysian facilities have delayed the U.S. approval of its Mylan-partnered Lantus copycat for the second time. CStone Pharmaceuticals has yet to start generating sales, but that didn't stop its CEO from collecting nearly $20 million in pay last year. As potential buyers line up for Novartis' Grimsby, U.K. site, the Swiss drugmaker has penned a deal to sell its Suzhou, China, site to a local company for $111 million. And more.
1. Mylan's Lantus copy derailed in U.S. again by manufacturing ills
Biocon’s manufacturing problems have once again interfered with partner Mylan’s winning approval for a Lantus copy. The FDA issued a second complete response letter for the drug “pending completion” of improvements at Biocon’s Malaysian facilities, where the FDA had previously found a dozen problems in need of fixing. Biocon said it does not anticipate the CRL will delay the commercial launch.
2. Young startups on new-look Hong Kong exchange see major CEO pay packets
Hong Kong-listed Chinese biotech CStone Pharmaceuticals hasn’t even started making money yet, but its CEO, Jiang Ningjun, is already racking up top U.S. Big Pharma-level pay. Jiang’s total compensation reached 141.25 million yuan (just under $20 million) last year, on par with the $20.9 million Merck & Co. CEO Ken Frazier collected during the same period.
3. Novartis selling manufacturing site to Chinese drugmaker
Just weeks after GlaxoSmithKline sold its Suzhou, China factory to Fosun Pharma, Novartis has decided to hive off its ingredients operation in the same city to China’s Zhejiang Jiuzhou Pharma for 790 million yuan ($111 million). The two go way back in their collaboration, and the new deal will allow the Chinese firm to continue supplying Novartis with ingredients while beefing up its own CDMO business, it says.
4. Insilico's AI networks generate custom lead compounds for fibrosis in less than 50 days
Insilico Medicine’s computer networks could potentially speed up drug discovery hit-to-lead timelines, the Hong Kong-headquartered company showed in a paper published in Nature Biotechnology. In less than 50 days, the company and its partners used AI programs to generate and select promising drugs against fibrosis and had the lead candidate go on to show favorable activity in mouse models.
5. Boehringer taps Lupin’s MEK inhibitor for pairing with its own KRAS cancer drug (release)
Indian drugmakers, better known as generics and API suppliers, are pivoting to more lucrative innovative therapies. Lupin is one of them. The Indian firm’s lead MEK inhibitor, LNP3794, has attracted Boehringer Ingelheim, which is shelling out $20 million up front and committing more than $700 million for rights to pair it with its in-house KRAS inhibitor in KRAS-driven gastrointestinal and lung cancers.
6. Water leak fixed with zip ties indicative of Dr. Reddy's sterile plant failings
At Dr. Reddy’s oncology plant in Duvvada, India, someone tried to fix a water tube connecting equipment in the fill-and-finish area with three zip ties, causing sterility problems. That’s one example of problematic operations the FDA laid out in an eight-observation Form 483 for the facility. It was the plant’s second citation in less than a year.
7. WuXi AppTec launches new service to deliver more shots on goal for drug discovery
WuXi AppTec launched its DELight service aimed at making “cost-effective and efficient hit finding services” to speed up early drug discovery. DELight, or DNA Encoded Library, is a self-serve product that gives researchers direct access to a collection of more than 8 billion compounds.
8. South Korean CDMO consolidates, plants flag in California
South Korean conglomerate SK Holdings is merging its SK Bioteck operations in Korea and Ireland with Ampac Fine Chemicals in the U.S. to form SK Pharmteco. The new CDMO will be headed by Ampac CEO Aslam Malik and headquartered in Sacramento, California.
9. Korean drugmaker buys large Vietnamese plant
South Korea’s JW Pharmaceutical has acquired Euvipharma, getting a 35,000-square-meter manufacturing facility in Vietnam that once belonged to Valeant. The plant, reportedly the largest in Vietnam, can produce up to 1.9 billion units a year. JW intends to use it as a base to export to other Asian countries and for contract manufacturing.
马来西亚 Biocon 工厂的持续改进延缓了美国第二次批准其与 Mylan 合作的 Lantus 仿制药。CStone Pharmaceuticals 尚未开始创造销售额,但这并没有阻止其 CEO 在去年获得近 2000 万美元的薪酬。随着潜在买家排队购买诺华的 Grimsby,英国瑞士制药商 site 已签署协议,以 1.11 亿美元的价格将其位于中国苏州的 site 出售给一家当地公司。更多。1. 迈兰的来得时副本在美国出轨Biocon 的生产问题再次干扰了合作伙伴 Mylan 获得来得时仿制药的批准。FDA 针对该药物“待完成”的马来西亚 Biocon 工厂的改进情况发出了第二封完整的回应函,此前 FDA 在该工厂发现了十几个需要修复的问题。Biocon 表示,预计 CRL 不会推迟商业发布。像这样的免费每日通讯?订阅 FiercePharma!生物制药是一个快速增长的世界,每天都有大的想法出现。我们的订户依靠 FiercePharma 作为最新的新闻、分析和数据的必读来源,以及制药公司。今天注册,以获得医药新闻和更新交付到您的收件箱和阅读的走。现在订阅 2。在新貌港交所上市的年轻初创公司看到,在香港上市的中国生物技术公司 CStone Pharmaceuticals 尚未开始盈利,但其 CEO 江宁军已经在美国排名靠前。高药剂师水平工资。姜建清去年的总薪酬达到 1.4125 亿元(略低于 2000 万美元),与默沙东公司的 2090 万美元相当。CEO Ken Frazier 同期收集。3. 诺华向中国制药商出售生产场地就在葛兰素史克将其中国苏州工厂出售给复星医药数周后,诺华决定以 7.9 亿元(约合 1.11 亿美元)的价格将其在同一城市的成分业务分拆给中国浙江九洲药业。两家公司的合作可以追溯到很久以前,该公司表示,新协议将允许诺华继续提供原料,同时加强自己的 CDMO 业务。4. 总部位于香港的 Insilico 公司在《自然生物技术》杂志上发表的论文显示,Insilico 公司的 AI 网络在不到 50 天的时间内产生定制的纤维化先导化合物 Insilico Medicine 公司的计算机网络可能会加速药物发现的“击中先导”时间线。在不到 50 天的时间里,该公司及其合作伙伴利用 AI 项目产生并选择了有前途的抗纤维化药物,并让候选药物在小鼠模型中表现出良好的活性。5.Boehringer taps Lupin 的 MEK 抑制剂与自己的 KRAS 抗癌药(发布)配对印度制药商,更好地称为仿制药和 API 供应商,正转向更有利可图的创新疗法。卢平就是其中之一。这家印度公司领先的 MEK 抑制剂,LNP3794,已经吸引了勃林格殷格翰公司,该公司正在炮轰 2000 万美元,并承诺超过 7 亿美元的权利,它与其内部 KRAS 抑制剂在 KRAS 驱动的胃肠道和肺癌配对。6. 用指示 Dr 的扎带固定漏水。雷迪博士的无菌工厂故障。在印度杜瓦达的雷迪肿瘤厂,有人试图用三根扎带固定灌装区的水管连接设备,造成无菌问题。这是 FDA 在 8 份观察表 483 中列出的有问题操作的一个例子。这是该植物在不到一年的时间里第二次被引用。7. 药明康德推出全新服务,为药物发现传递更多的命中目标药明康德推出的欣喜服务,旨在让“性价比高、效率高的 hit finding services”加速早期药物发现。DELight,即 DNA 编码文库,是一种自助式产品,让研究人员直接获得超过 80 亿种化合物的集合。8、韩国 CDMO 合并,位于加州的 plants flag 韩国企业集团 SK Holdings 正在将其在韩国和爱尔兰的 SK Bioteck 业务与美国的 Ampac Fine Chemicals 合并。形成 SK Pharmteco。新的 CDMO 将由 Ampac CEO Aslam Malik 领导,总部位于加州萨克拉门托。9、韩国制药商收购越南大型工厂韩国 JW 制药公司收购 Euvipharma 公司,获得了位于越南的 3.5 万平方米的生产设施,该设施曾属于 Valeant 公司。据报道,该厂是越南最大的工厂,年产量可达 19 亿台。JW 计划将其用作出口至其他亚洲国家和合同制造的基地

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