Life Sciences and Healthcare
ZSK life sciences and healthcare team provides services to global leading life sciences and healthcare enterprises on their legal and commercial matters, including pharmaceutical, vaccine, biotech and medical device companies, digital health businesses and technology companies expanding into this sub-sector, service providers for hospitals and academic medical centers, as well as investors in life sciences and healthcare industry.
Our life sciences and healthcare team has deeply engaged in life sciences and healthcare sector for decades, covering whole-industry-chain and entire product life cycle, including R&D and co-development, preclinical studies, clinical trial, regulatory approval and marketing of pharmaceuticals and medical devices (collectively, the “Products”). ZSK is renowned for providing professional legal support for technology licensing and transfer, clinical trial management (CRO, SMO, subject recruitment, monitoring, data protection, etc.), Product commercialization (production, promotion, distribution, delivery, etc.), adverse event reporting and product recalls, resolution of dispute with subject, medical service, and other matters concerning the Products. ZSK is well versed in supporting the incubation and acceleration of new enterprises and Products as well as cross-border Products R&D and trade. Leveraging our strengths in domestic and global capital markets and dispute resolution, data security and privacy protection, anti-unfair competition and trade secrets protection and anti-commercial bribery, we provide a full spectrum of integrated legal services to life sciences and healthcare enterprises.
ZSK life sciences and healthcare team comprises of attorneys and patent agents with a dual background in biochemistry and law. They have had extensive experience working in leading domestic and international law firms, government agencies, reputed pharmaceutical companies, courts, research institutions and other organizations.
Venture capital and private equity investment, FDI, merger and acquisition, securities and capital markets, establishment of RMB fund, employee equity incentives, etc.
Real estate, construction, dispute resolution, etc.
Corporate finance, financial capital market (such as listing and refinancing in domestic and foreign capital market), merger & acquisition, private equity investment, project financing (such as mining project financing), real estate development and operation, and other commercial legal services.
Foreign investment, financial capital market (such as domestic and foreign capital market listing, refinancing, etc.), wealth management, family trust, global residence & nationality planning, mergers and acquisitions, private equity investment, project financing (such as mineral resources, etc.), banking and real estate and other commercial legal services.
Venture capital and private equity, merger and acquisition, life sciences and healthcare, wealth management, etc.
Marriage and family, inheritance, labour and employment, litigation and arbitration, corporate compliance, etc.
Venture capital and private equity, securities and capital markets, establishment of RMB fund, employee equity incentives, corporate compliance, etc.
Lihong DUAN is proficient at handling difficult and complex intellectual property and major foreign-related commercial disputes and anti-monopoly cases, including those in pharmaceutical and communications industries, as well as IP-related litigation and other related legal services.
REPRESENTATIVE EXPERIENCE
- Advise ChemPartner (ChiNext: 300149), as its regular legal counsel, throughout business processes, from research and development, design, custom synthesis of chemical drugs to process development for and production of biological drugs and chemical drugs, on design of transaction structuring, corporate compliance and internal control, data compliance, intellectual property protection and trade secret protection according to its business situation;
- Advise Ascentage Pharma (06855.HK), as its regular legal counsel, on new drug discovery, clinical trial, multi-center study, cross-border cooperation, compliance, and other matters. ZSK life sciences team and dispute resolution team represented Ascentage Pharma in clinical trial disputes on an urgent basis, some of which occurred at the critical stage when Ascentage Pharma just had listed in the capital markets or at seeking for follow-up financing. ZSK life sciences team and dispute resolution team proposed an appropriate dispute resolution scheme to Ascentage Pharma in the shortest possible time and brought the parties to agreement thereon, protecting Ascentage Pharma’s rights and interests to the fullest extent;
- Advised China Health Group (08225.HK) as its regular legal counsel on PRC laws related matter in connection with a series of clinical trials (Phase I, II and III) of Ritonavir MaiKeXin (PF-07321332), an effective drug against COVID-19, and represented China Health Group in the international registration and post-marketing production and sale of the drug. On March 14, 2022, the National Health Commission issued the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 9), adding PF-07321332 Ritonavir as the treatment. Ritonavir MaiKeXin (PF-07321332) has been marketed. ZSK also advised China Health Group on the commercialization, production and sales of its marketed drugs in Greater China, including transaction scheme design, transaction document drafting and commercial negotiation. ZSK represented China Health Group and several well-known multinational pharmaceutical companies in the registration, clinical trial, commercialization, production and sales of on their products in China, including but not limited to assisting clients in drafting domestic and overseas transaction documents and participating in multi-party negotiations. ZSK also advised China Health Group on the establishment of compliance policies and systems, including its rules and regulations, internal risk control system, litigation risk control system, and trade secret and file management system;
- Advised Lepu Medical (ChiNext:300003) on its initial public offering on the ChiNext and as its regular legal counsel on listed company information disclosure, corporate compliance and other matters;
- Acting as InxMed's legal counsel, ZSK life sciences and healthcare team provides InxMed with all-round legal support for its rapid development demonstrating excellent capability and efficiency. ZSK advised InxMed on its R&D and clinical trial on new drugs in China and abroad, as well as in clinical trials, CRO, SMO, IIT, entrusted production, material transfer, product quality control, combination treatment, intellectual property protection and data compliance, human genetic material and biosecurity, and other matters; advised InxMed on its clinical trial cooperation with a number of well-known multinational pharmaceutical companies (e.g. MSD, AZ, Eli Lilly, Abbvie, Oncomatryx, BeiGene, etc.) on FAK inhibitor (IN10018) and combination treatment, and assisted InxMed with several rounds of financing. Our team assisted InxMed in application for U.S. FDA Fast Track Designation for its first independently-developed new drug, FAK (focal adhesion kinase) small molecule inhibitor IN10018 and Breakthrough Therapy Designation by China National Medical Products Administration (NMPA) and helped InxMed to launch its critical Phase II clinical trial in September 2022 with the aim of marketing;
- As Simoon Record’s regular legal counsel, ZSK built a compliance system for it and continues to provide a full range of legal services focusing on clinical trial, also providing legal assistance in clinical trial service and entrustment, product registration, trade secret protection, pharmacovigilance, institution management, subject recruitment, clinical research coordination (CRC), E-source system development, and other matters. ZSK provides full-process legal services and assistance for major deals and projects of Simoon Record, and has participated in many cooperation projects with Toyouvax Bio-Pharmaceutical, Kanghua Biological, Weiguang Biotechnological, Sanroad Biological and other companies on vaccine process development and commercialization, and provided legal support for orderly proceeding of the projects; ZSK has advised Simoon Record on 13-valent pneumococcal conjugate vaccine, S-Trimer (a protein subunit vaccine candidate for Alpha+Beta variants), quadrivalent influenza vaccine (split virion), Phase III (adult) on North China Pharmaceutical’s Ormutivimab Injection, human papillomavirus vaccine [bivalent (16/18), recombinant] and other vaccines projects, and in such projects, ZSK advised Simoon Record on transaction structuring, transaction document drafting, commercial negotiation, CRO and SMO compliance and subject data protection and provided compliance trainings. ZSK represented Simoon Record on claim declaration in Changchun Changsheng bankruptcy case, in which, ZSK communicated and negotiated with the administrator throughout the process, and drafted a full set of documents including legal opinions, and in the end, all the tens of millions of RMB of claims declared by the client were supported and paid;
- ZSK advised Stemexcel as its regular legal counsel on global Phase III clinical trial of COVID-19 vaccines. After the outbreak of COVID-19, firstly only five vaccines were approved for marketing in China, i.e., inactivated vaccines from National Vaccine and Serum Institute , Wuhan Institute of Biological Products and SINOVAC, adenovirus vector vaccines from CanSino Biologics Inc., and recombinant protein vaccines from Zhifei Biological Products Co., Ltd. , and two were approved for emergency use, i.e., inactivated vaccines from Shenzhen Kangtai Biological Products Co., Ltd. and Institute of Medical Biology, Chinese Academy of Medical Sciences. In addition, there are several mRNA vaccines are undergoing clinical trials. As the top Global Centre CRO for COVID-19 vaccines in China, Stemexcel provided services for the overseas clinical trials of all foregoing enterprises, and as the legal counsel of Stemexcel, ZSK provided legal support for the foregoing global clinical trials cooperations and transactions;
- Provided Nanjing Bio-tech and Pharmaceutical Valley (NJBPV), as its regular legal counsel, full-process legal advice for attraction of biomedical industry investment, generation of biopharmaceutical companies, investment and financing, communication and publicity of the latest laws, regulations and policies, construction, bidding and bid calling management, etc.;
- Advised iKang Guobin, as its regular legal counsel, on its privatization and delisting from NASDAQ as well as foreign exchange and tax and domestic business compliance issues;
- Assisted Zewei Biotechnology, as its legal counsel, in completing the angel round of financing, participated in throughout the entire process of project, and provided legal services including transaction document drafting, transaction negotiation and financing closing. While serving as its legal counsel, ZSK provided Zewei Biotechnology with all-round legal support for its target-related screening and testing, equipment procurement, equity incentive and other matters;
- ZSK advised a national research institution, as its regular legal counsel, on drug and device research, clinical research, intellectual property, customs, labor and employment, construction, bidding and bid calling, and other matters, covering document drafting, providing compliance advice, participating in business negotiation, and issuing legal opinions on professional issues;
- Advised Eyedeal, as its legal counsel, on transfer and licensing of key patents related to new materials and medical devices, compliance of lens data collection, protection of intellectual property rights in and to new materials and medical devices, red-chip restructuring, overseas Series A private equity financing, employee equity incentive plan, and other matters;
- Advised Iquickmove as its regular legal counsel since its incorporation on compliance system establishment, anti-corruption and advertising compliance, risk segregation a for new “online + offline” operation mode; provided integrated legal support and assisted the client in becoming a rising star in the recruitment sector in a short time, including full-process services in cooperation, user management, privacy protection, informed consents, and recruitment;
- Advised Key Tech its regular legal counsel on its core business (clinic trial data statistics), preparation of template clinic trial data statistics service agreements and represented Key Tech in commercial negotiation; assisted Key Tech in completing data statistics for hundreds of clinical trials;
- ZSK life sciences and healthcare team advised AllinMD Orthopaedics as its legal counsel on establishment of its VIE structure, several series of financing and employee equity incentive plan;
- Advised Medtronic (NASDAQ: MDT), as its Chinese counsel, on medical device data protection compliance, including special data surveys and data audits on Medtronic’s medical device data in China, designed mechanisms for personal information collection and authorization, conducted cross-border data transfer security assessments and personal information security impact assessments, responded to data subjects’ requests for exercise of rights, and provided advice on compliance rectifications;
- Advised Merck as its Chinese counsel in terms of pharmaceutical industry and data compliance, on establishing data protection governance structure for its business in China. We assisted Merck in developing a data protection strategy and establishing a data compliance system, and designed a full set of business processes and management policies in compliance with EU GDPR, and privacy and personal information protection laws of China and other Asia-Pacific countries;
- Advised Alliance Healthcare as its Chinese counsel on corporate compliance, such as compliance analyses on its business model in China, anti-corruption, R&D cooperation in China, sales project, license-out, and so forth;
- Advised a Danish pharmaceutical company on negotiation with a PRC company for an exclusive license-out transaction of its first-in-class PD-1 inhibitor, participating in the business and term negotiation with the PRC company and helped with the drafting and revising of the exclusive license agreement.
