Eden Biologics, Inc.

Bora Pharmaceuticals continued its global expansion push by buying a stake in Taiwanese drugmaker Tanvex Biopharma. Bora Pharmaceuticals extended its expansion tear by taking a 30.5% stake in fellow Taiwanese drugmaker Tanvex BioPharma, boosting the CDMO’s biomanufacturing capabilities.The deal, which is expected to be completed in the first quarter of 2025, will make Bora the largest shareholder in Tanvex. It also gives Bora access to Tanvex's commercial-scale production facility in San Diego, the CDMO said in an Aug. 27 press release.Tanvex boasts more than 100,000 square feet of biomanufacturing space and operates 1,000- liter bioreactors, which will complement Bora’s 500-liter bioreactors, Bora added. The companies "will combine their biomanufacturing facilities to create a global solution for biologics development and supply," according to Bora's release.Bobby Sheng, Bora Group’s chairman and CEO, will become chair of the merged organization.“This partnership will enable the combined entity to rapidly respond to evolving industry demands and policy developments, such as the BIOSECURE Act in the US, and capitalize on new opportunities in onshoring, friendshoring, and the growing CDMO demands driven by these policy changes,” Sheng said in the release. The investment in Tanvex is the latest move in Bora’s global expansion march.In June, Bora shelled out $30 million to snap up Emergent’s fill-finish drug product facility in Baltimore that offers clinical and commercial nonviral aseptic fill-finish services on four fill lines, including lyophilization, formulation development and support services.That acquisition followed January’s $210 million acquisition of Minnesota generics manufacturer Upsher-Smith Laboratories that gave Bora a foothold in the U.S.In 2022, Bora purchased fellow Taiwanese company TWi Pharmaceuticals, gaining two manufacturing facilities and some niche technologies, and it also bought Eden Biologics' CDMO business.

The sale represents one piece in Emergent’s plan to deprioritize its CDMO business. The asset sale portion of Emergent BioSolutions’ sweeping restructuring plan is taking shape. In a $30 million deal, Emergent has agreed to sell its fill-finish drug product facility in Baltimore to growing Taiwanese CDMO Bora Pharmaceuticals, the two companies said Thursday. The 87,000-square-feet Camden facility offers clinical and commercial non-viral aseptic fill-finish services on four fill lines, including lyophilization, formulation development and support services. About 350 Emergent employees are expected to join Bora as part of the transaction, which is expected to close in the third quarter of 2024, according to Emergent. Bora, through a media aide, confirmed to Fierce Pharma via email that the company plans to keep all existing employees at the plant. “The decision to sell our Camden manufacturing facility is aligned with our multi-year plan to create a customer focused, leaner and more flexible organization, while we improve overall profitability and raise capital to reduce our debt,” newly minted Emergent CEO Joe Papa said in a statement Thursday. The Camden site doesn’t have the most pristine track record. Following an FDA Form 483, the plant was slapped with an FDA warning letter in 2022 that detailed problems related to equipment cleaning, aseptic sterilization techniques and procedures, and quality systems. The problems were deemed adequately addressed and the warning letter closed following another FDA inspection last summer. The sale represents one piece in Emergent’s plan to deprioritize its CDMO business. About two months into his CEO role, Papa in May unveiled a restructuring initiative to reduce the company’s workforce by about 300 employees and to shut down two manufacturing facilities, while exploring strategic alternatives for some other plants. The two facilities being closed are located in Baltimore-Bayview and Rockville, Maryland. The Camden facility belongs to the group of sites for which Emergent has been weighing its options. Besides sites in Winnipeg, Canada, and Lansing, Michigan, which Emergent said it will keep, the company also owns about 122,500 square feet of manufacturing and warehouse space in Canton, Massachusetts, where Emergent has scaled back operations. In contrast to Emergent’s shrinking interest in the CDMO field, Bora has been on an expansion spree. The Taiwanese company just established a U.S. footprint earlier this year with a $210 million acquisition of Minnesota generics manufacturer Upsher-Smith Laboratories. The Upsher-Smith buy followed two acquisitions by Bora in 2022. Through the purchase of fellow Taiwanese company TWi Pharmaceuticals, Bora gained two manufacturing facilities and some niche technologies. The same year, Bora beefed up its biologics capabilities by acquiring Eden Biologic’s CDMO business. Buying the Camden sterile injectable fill-finish plant “not only demonstrates our commitment to our growth strategy and plans for expansion in North America, but also enables us to expand our offering for our biologics customers,” Bora CEO Bobby Sheng said in a statement Thursday. Without offering further details, Bora said it has “ambitious plans to enhance the newly acquired facility.” And the company is “always considering sites that are available,” Bora told Fierce Pharma. “We are planning to expand our operations across the US market to significantly enhance Bora’s position as a global competitor,” the company said. “As part of our growth strategy, we are constantly listening to our customer's needs to spot opportunities to provide the best possible service.”

作者｜自由译员Isabelle 一年半前，珐博进对两位前雇员提起诉讼，指控后者窃取珐博进的商业机密。近期，诉讼结案，原被告双方均全身而退。杭州安道药业有限公司及其在美国的实体Kind制药有限责任公司（“安道药业”）、安道药业CEO刘栋博士、安道药业首席科学官邓绍江博士，近日宣布与珐博进达成协议，解决了双方关于商业机密的争端，同意撤回法律诉讼。 根据Kind发布的新闻稿，珐博进和安道药业均无需做出任何支付或赔偿。  01  息讼止纷，安道药业继续前行2022年12月，珐博进起诉前雇员刘栋和邓绍江，指控他们窃取了缺氧诱导因子脯氨酰羟化酶抑制剂（HIF-PHI）的专有信息，并不当地提出了专利申请。HIF-PHI是一类治疗贫血的药物，珐博进的安斯泰来（Astellas）和珐博进与阿斯利康合作的罗沙司他（roxadustat）皆属于HIF-PHI。刘栋和邓绍江都曾在珐博进工作多年，刘栋曾任首席研究员，并参与了罗沙司他的开发，邓绍江曾任高级药物研究员。2013年，刘栋尚在珐博进工作时，就创立了Kind制药有限责任公司，两年后才离开珐博进。邓绍江2019年加入珐博进，担任领导职务。刘栋还创建了杭州安道药业有限公司，担任董事长、CEO和总经理，之后才正式从珐博进离职。根据起诉书，刘栋和邓绍江在珐博进不知情或未同意的情况下，就珐博进的化合物申请了一系列专利。这些专利中所列举的发明人是错误的，发明这些化合物的珐博进科学家都榜上无名，这些专利都被错归到了Kind名下。珐博进指控这两位前雇员蓄谋通过非法的手段使Kind获得抢跑优势，从而无需花费多年时间来开发、识别具有临床疗效的HIF-PHI。珐博进的律师曾在诉讼中表示，如果没有窃取珐博进的知识产权，Kind不可能成立仅六年就能够开展HIF-PHI的临床试验。珐博进原本的诉求是禁止Kind使用珐博进的专有信息，并对Kind施压，要求Kind将珐博进列为Kind HIF-PHI各项专利的专利权所有人。珐博进还希望得到补偿，并且希望两位前雇员放弃从“错误”专利申请中获得的利润。Kind制药旗下HIF-PHI药物AND017处于领先地位，和解生效后，Kind可以继续开发该药物以及管线中的同类药物，根据Kind网站上的在研药物信息，AND017在治疗贫血和肿瘤相关性贫血方面，目前正处于临床二期阶段。 安道药业在研药物AND017是安道公司为治疗新型贫血类疾病开发的口服小分子化合物, 用于治疗慢性肾病引起的贫血症， 通过特异性地抑制脯氨酸羟基化酶，在低氧水平下，使体内“促红细胞生成素”（EPO）激素水平升高，导致红细胞数量增加。安道公司拥有该药的全球知识产权。2019年4月，该药临床申请获中国药监局批准。2020年7月启动在澳洲的一期临床试验。2021年1月，FDA批准AND017进入美国二期临床试验。2022年5月，AND017新适应症肿瘤相关性贫血药物获批中国二期临床。刘栋在申明中称：“我们很高兴最终能够全面解决这些争端。随着这些纠纷事过翻篇，如今Kind可以专注于将创新的产品管线推向市场。”而珐博进的罗沙司他虽在欧洲、中国、日本等国家销售，却在美国接连受挫，可谓命运多舛，尤其是二月份阿斯利康将罗沙司他在多个国家的权利归还给珐博进，仅保留了在中国和韩国的权利。该药在中国和韩国获批的品牌名为Evrenzo。去年5月，罗沙司他治疗骨髓异常增生综合症(MDS)的三期临床试验以失败告终。2021年8月，FDA拒绝批准将罗沙司他应用于治疗与慢性肾病相关的贫血。  02  锐格与辉瑞的GLP-1之争，以和解收尾随着中国创新药企走出去开拓海外市场，类似的侵权纠纷，可谓屡见不鲜。2022年2月，辉瑞起诉两名前雇员，钟敏和邱夏杨盗用商业机密，成立竞争公司锐格医药。 辉瑞在起诉书中指控二人在2018年6月从辉瑞离职前就开始收集关于辉瑞药物开发计划的文件，包括在研化合物和其他商业机密。诉讼的焦点在于二人是否有窃取涉及开发胰高糖素样肽-1（GLP-1）小分子激动剂的信息。GLP-1可以刺激胰岛素生成。彼时，有几款获批的药物能够靶向GLP-1上的受体，治疗糖尿病和肥胖，但是无一例外均需注射。而辉瑞当时有两款口服小分子GLP-1受体激动剂正在开展临床试验，其中一款danuglipron已进行到二期。2018年11月，锐格医药公布了一系列GLP-1受体激动剂的专利，辉瑞称这些专利与辉瑞开发的药物“惊人地相似”。其中锐格的RGT-075正处于临床试验阶段。锐格医药的研发管线业界普遍认为这场诉讼的导火索是在辉瑞起诉前两个月，锐格医药与礼来达成了开发协议，在改善代谢指标方面展开合作。锐格医药收到了5,000万美元的预付款，各项里程碑付款合计起来，此项交易的潜在价值可高达10亿美元。辉瑞发起诉讼一个月后，钟敏和邱夏杨发起反诉，否认所有指控。最终，去年7月，这场诉讼以和解收尾。辉瑞和锐格医药都放弃了对对方的指控，各自承担自己的成本和法律费用。  03  前基因泰克员工锒铛入狱如果说前两个案子的当事人以握手言和收场还算是个不错的结局，接下来提到的这几位就没有这么幸运了。2022年10月，基因泰克前雇员Xanthe Lam及其丈夫Allen Lam被判处6个月有期徒刑，每人罚金超1万美元，获释后，还要接受3年监控。根据法庭文件，Xanthe Lam和Allen Lam承认盗窃基因泰克商业机密，并从事数起计算机欺诈及滥用犯罪活动，外加几项其他指控。此案件耗时4年，引起高度关注，政府公诉人称这对夫妇窃取的知识产权关乎基因泰克的明星产品利妥昔单抗（Rituxan）、曲妥珠单抗（Herceptin）、贝伐珠单抗（Avastin）以及囊性纤维化吸入剂阿法链道酶（Pulmozyme）。夫妇二人将机密信息提供给中国台湾公司“喜康生物”（现已更名为“伊甸生医”），帮助该公司仿制药物。比起其他涉事的共犯，这对夫妇得到的惩罚已经算是轻判了。两位喜康生物的联合创始人，前CEO Racho Jodanov和前COO Rose Lin被判处1年零1天监禁，此外，还需在服刑后继续在家禁闭3年。早在喜康生物成立之前，窃取行为就开始了，一直持续至2019年。喜康生物特意聘用基因泰克前雇员，盗取机密信息。尽管喜康生物并没有全部使用窃得的信息，但是一直纵容这种行为，也丝毫不阻拦员工使用这些信息，走了不少捷径。Xanthe Lam卷入其中是从Rose Lin秘密安排她担任配方部门的负责人开始的，当时Rose Lin明知她同时在基因泰克还有份全职工作。Rose Lin通过Allen Lam付款给她，这样Xanthe Lam无需与喜康生物直接接触即可开展工作。此外，喜康生物的其他人员通过Xanthe Lam丈夫的邮箱与她保持联系。  写在最后  近年来，跨国药企一边断舍离一边买买买，必然加速人才流动。研发机密作为公司最核心的资产，第一道防线固然是雇员的职业操守，但公司更应该思考如何从制度上、流程上、技术上筑好护城河。同时，中国创新药企也需要意识到，在成熟的经济体，运用法律武器狙击竞争对手是司空见惯的竞争手段，也并非只针对华人科学家，公司需要从顶层设计一套切实可行、着眼于公平竞争的知识产权保护战略，不存侥幸心理，避免陷入不必要的法律纠纷，也能够在自身合法权益受损时，予以反击。参考资料：Fierce Pharma: FibroGen, former employees settle dispute over alleged trade secrets theftFierce Pharma: AstraZeneca partner FibroGen slaps former employees with trade secret theft lawsuitFierce Pharma: In trade secrets case, ex-Genentech staffer and husband get 6-month prison sentencesPharmalive: BIOPHARMA LAWSUIT TRACKER 2023: PFIZER SETTLES TRADE SECRETS CASEChemical & Engineering News: Regor countersues Pfizer in trade secret theft case安道药业官网锐格医药官网研发客公众号:《辉瑞锐格和解，对本土药企有何启示？│第一现场》  BiG 十周年预告  本次BiG十周年庆典，将首次分为国内和国际篇章，以原创科学和临床需求为出发点，讨论创新技术平台和创新疗法（PROTACT/分子胶、双抗/ADC、siRNA/ASO、CGT、AI制药）的重大进展和发展前景，十年一药曙光现，大浪淘沙始见金！▼报名参会 会议门票：审核制(免费)；含主论坛+分论坛，不含餐；优先biotech/Pharma、临床、院校科学家共建Biomedical创新生态圈！如何加入BiG会员？