作者: 黄建雯    张运帷   钱恒   张宇   金杜律师事务所

引进药品品种、转让药品技术是医药企业之间常见的合作模式,也是药品资产交易长期活跃的领域。作为一项技术高度集中、资金占用巨大、独具行业特色的交易类型,我们结合实务经验,根据药品类型与研发阶段的不同情况,总结了一些常见的药品资产交易模式。本万字长文包含三个部分:(1)概述现行法律框架下药品资产交易的各类常见模式;(2)以进口药品License-in交易为例对协议要点进行进一步梳理;(3)探讨新版《药品管理法》出台后对药品资产交易的影响。 Continue Reading 图文详解药品资产交易模式与协议

作者:袁敏   林喆   赖云婕   金杜律师事务所

为深入贯彻落实党中央、国务院在中央经济工作会议和全国金融工作会议上关于金融工作的有关精神,进一步加强保险公司关联交易监管,防范金融风险,中国银行保险监督管理委员会(以下简称“银保监会”)近日发布了《保险公司关联交易管理办法》(下称《办法》),该办法自发布之日起施行,同时废止了原中国保险监督管理委员会(以下简称“原保监会”)此前发布的《保险公司关联交易管理暂行办法》(保监发〔2007〕24号)、《关于执行<保险公司关联交易管理暂行办法>有关问题的通知》(保监发〔2008〕88号)、《中国保监会关于进一步规范保险公司关联交易有关问题的通知》(保监发〔2015〕36号)、《中国保监会关于进一步加强保险公司关联交易信息披露工作有关问题的通知》(保监发〔2016〕52号)以及《关于进一步加强保险公司关联交易管理有关事项的通知》(保监发〔2017〕52号)。通过整合和修改原保监会于2008年、2015年、2016年、2017年对关联交易计算、比例限制、信息披露、内控相关制度补充的零散规定,《办法》的颁布使我国保险公司关联交易的监管制度走向统一和完善。以下我们就《办法》的主要内容与其较原有规定的重大修改进行简要介绍。 Continue Reading 保险公司关联交易监管新规 :《保险公司关联交易管理办法》解读

Given the significant levels of early international support for the Singapore [Mediation] Convention[1] and the growing popularity (and success) of international commercial mediation (see https://www.kwm.com/en/jp/knowledge/insights/in-anticipation-of-this-month-s-singapore-mediation-conference-20190806), tiered dispute resolution clauses (“TDRCs”) are very much in focus for many corporate counsel.  In several industries, for example the energy industry where parties are often engaged in complex long-term contractual relationships that require continuing, day-to-day cooperation, TDRCs are already widely used as a way of solving potential disputes as and when they arise and saving ongoing working relationships.  Nevertheless, there are some pitfalls that you need to be aware of and so we will look at: Continue Reading TIERED DISPUTE RESOLUTION CLAUSES | why you should use them and how to make sure they work

by  Stanley Zhou, Minny Siu, Stella Wang, Andrew Fei and David Mu

Last week, China’s foreign exchange regulator – the State Administration of Foreign Exchange (“SAFE”) – announced the removal of investment quota limits for qualified foreign institutional investors (“QFIIs”) and renminbi qualified foreign institutional investors (“RQFIIs”).  This signals the further opening-up of China’s financial markets to foreign investors.  Continue Reading (R)QFII: 5 things you need to know after removal of investment quota

作者: 孟凡宏   王月     金杜律师事务所

2017年,两款CART产品(即,NH的Kymriah和KT的Yescarta)分别获得FDA的上市批准。这两款CART产品成功地证明了细胞免疫疗法在治疗肿瘤方面的美好前景,加上巨大的市场规模,使得各家药企和研究机构均在积极推进CART药物的研发和临床研究。作为目前生物医药界的热点,我们在此简单梳理了CART技术的发展和现状,以及主要申请人在中国的专利布局,从而一窥各家药企或研究机构的CART研发进度以及竞争格局。 Continue Reading CART免疫疗法的发展现状以及在中国的专利战场

作者:黄建雯   金杜律师事务所

 

历经多年的讨论,《中华人民共和国药品管理法(2019修订)》(以下简称“新版《药品管理法》”)终于2019年8月26日由第十三届全国人民代表大会常务委员会第十二次会议通过,并将于2019年12月1日正式施行。这次新版《药品管理法》修改幅度之大,内容变化之多是史无前例的,有很多新的亮点,也引入很多新的制度和规定。新版《药品管理法》特别增设第三章“药品上市许可持有人”,用独立的一整章来规定药品上市许可持有人制度,包括药品上市许可持有人的主体资格、药品上市许可持有人的权利、义务和责任等等。此外,药品上市许可持有人的相关内容亦在新版《药品管理法》的其他章节大量出现。这标志着药品上市许可持有人制度在历经四年的试点工作后,终于将正式登上舞台,成为一项全国通行的制度,并将对未来的医药行业、药品的管理产生深远影响。 Continue Reading 药品上市许可持有人制度–新版药品管理法下重要制度

作者:田文静、张琛、蔡予蒙

作为近十年来非洲经济发展最为迅速的经济体之一,埃塞俄比亚(“埃塞”)在经济领域取得的成就在全球范围内都备受瞩目。国际货币基金组织(IMF)数据显示,埃塞近十年GDP平均增长率高达9.7%;而根据该组织预测,埃塞GDP在未来5年中仍将保持7%至7.5%的持续稳定增长[1]Continue Reading 埃塞俄比亚《PPP法》简析:机遇还是挑战?

by: Meg Utterback   Aaron Wolfson

On September 4, 2019, the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) imposed sanctions on a shipping network it said was run by Iran’s Revolutionary Guards, alleging it sold millions of barrels of oil to benefit Syrian President Bashar al-Assad.  According to an advisory that OFAC issued the same day, the United States is targeting private and public sector entities around the world that engage in sanctionable conduct relating to shipping petroleum and petroleum products from Iran to Syria, China, and elsewhere.  OFAC is implementing these sanctions by adding 16 entities, 10 individual and 11 vessels suspected of being involved in such sanctionable activities to its List of Specially Designated Nationals and Blocked Persons (SDN List).  Among them was Mehdi Group, an India-based ship management company that OFAC alleges handles crewing and management of at least 7 of the vessels used in the Iranian oil smuggling network.  Continue Reading New Sanctions: Petroleum and petroleum product shipments to Iran

作者:  冯晓鹏  刘艺涵  王溢美  金杜律师事务所

在上篇文章【一文读懂新《药品管理法》对进口药品监督之影响(上)】中我们详细梳理了新《药品管理法》出台后海关对于境外药品在进口环节的监管要求与具体通关流程,并初步提示了药品进口过程中应当防范的“雷区”,本篇文章将以案说法,进一步分析药品进口责任主体在进口、销售环节可能面临的行政及刑事风险。

Continue Reading 一文读懂新《药品管理法》对进口药品监管之影响(下)

China Eastern Airlines Corporation Limited (“Eastern Airlines”, 600115. SH), which received CSRC’s approval, has recently made a private placement of A-shares and H-shares in an important move to respond to the deepening of China’s mixed ownership reform of SOEs and calls for strategic cooperation between state-owned and private sectors. Continue Reading King & Wood Mallesons advises China Eastern Airlines’ mixed ownership reform