Pharmaceutical products are used to prevent, treat and diagnose diseases, and are subject to the Drug Administration Law of the People’s Republic of China, the Implementing Regulations of the Drug Administration Law of the People's Republic of China, and other special laws and regulations. In recent years, to adapt to the rapid development of the pharmaceutical industry, the breadth and intensity of drug regulatory reform in China has escalated dramatically, and the pace of China’s integration with the international drug regulatory system has increased significantly.
JunHe’s dedicated team has years of experience serving the pharmaceutical industry. With an in-depth understanding of the pharmaceutical industry, a broad client base and a good relationship with industry regulators, the scope of our service can cover all aspects of drug research and development, manufacturing, and commercialization. With experienced personnel from many different departments, our team can provide a one-stop service for pharmaceutical enterprises in areas such as regulatory, corporate and M&A, capital market, private equity/venture capital, intellectual property, compliance and dispute resolution.
We can provide the following legal services in the pharmaceutical industry:
Regulatory. We are able to not only provide legal services in relation to clinical trials, drug registration, and GCP/GMP compliance for drug development and manufacturing enterprises, but we can also advise on marketing, promotion, distribution, bidding and tendering, adverse drug reaction monitoring, and product recall. In particular, we are able to design and evaluate the optimal path for drug registration and commercialization for our clients, according to the latest drug review policies.
Drug licensing transactions. We have participated in many complex transactions that have involved drugs that are in the R&D stage or have been marketed. We have first-hand experience in cross-border co-development and licensing transactions for drug products.
Private equity and capital markets. Our clients include well-known investment institutions committed to the pharmaceutical sector, such as Sequoia, Qiming, Warburg Pincus, CITIC Capital and Ping An. We have also assisted many leading biotech companies, as well as listed companies who have achieved outstanding results in the pharmaceutical industry. We have participated in the listing of companies such as BeiGene, Shanghai Pharma, Xinhua Pharmaceutical i and NT Pharma.
Intellectual property. With a professional team of lawyers from our Silicon Valley, Shanghai, Beijing and Guangzhou offices, we are able to provide trans-regional, comprehensive and professional services for numerous innovative drug research and development companies across the country. In particular, we have had exceptional results in cases involving patent protection (including patent applications) and dispute resolution involving intellectual property.
Compliance. Our compliance services cover drug regulatory compliance, anti-trust compliance, anti-commercial bribery compliance, privacy protection and data security compliance. In addition to assisting clients in internal compliance investigations, we have vast experience in dealing with law enforcement actions by government agencies, and have established positive working relationships with law enforcement agencies, and are appreciated by clients for providing constructive and feasible solutions.
Recent Representative Cases
GuoDa Drugstore introduced international strategic investors with a capital increase of RMB 2.7667 billion
JunHe represented China National Accord Medicines Corporation Ltd. and provided legal services for its subsidiary, Sinopharm GuoDa Drugstore Co., Ltd, to receive RMB 2.7 billion from an international strategic investor. This was China’s largest cross-border joint venture in the pharmaceutical retail industry to date. JunHe provided the client with efficient, comprehensive and constructive legal services, including designing the transaction structure, assisting in the preparation of the transaction documents, participating in the drafting and negotiation of the contracts.
HD Biosciences Co., Ltd. sold its 100% Equity
JunHe assisted HD Biosciences Co., Ltd. in its sale of 100% equity to Wuxi AppTech. Headquartered in Shanghai, HD Biosciences is a leading pre-clinical research and development service platform in the industry. Acting as the PRC legal counsel to HD Biosciences and its original shareholders, JunHe fully participated in the early discussion, negotiations and revision of the transaction documents, as well as the final closing. JunHe assisted the company in arranging and coordinating the exit of different shareholders (including Pfizer, Lilly, Morningside Venture Capital, and other investors) and assisted in handling its domestic and overseas employee shareholding platform.
JD.com and Shanghai Pharma Jointly Build an Online Medical Sale Platform
Shanghai Pharma Health Commerce Co., Ltd. is a medical E-commerce platform developed by Shanghai Pharma. It is a prescription medicine O2O E-commerce platform combining online and offline resources, integrating services and trades, with “Internet+” as its core concept, so as to build three online platforms and an offline three-tier network. JunHe represented Beijing Jingdong Century Trade Co., Ltd. in the completion of the Series A financing for Shanghai Pharma Health Commerce Co., Ltd.
Series A Financing from Temasek for JW Biotechnology Co. Ltd.
JW Biotechnology Co. Ltd. is an innovative biotechnology company focused on the latest cell-therapy technology. It has introduced the products and the technical platform of Juno to China, and its CAR-T product JWCAR029 successfully applied for a clinical trial with the former China Food and Drug Administration. JunHe represented Temasek in the joint leading investment with Sequoia and Yuanming Capital in the USD 90 million Series A financing for JW Biotechnology.
Series B Financing from Temasek for Hangzhou Just Biotherapeutics Inc.
JunHe represented Temasek in the Series B Financing for Hangzhou Just Biotherapeutics Inc., and rendered legal services including legal due diligence investigation, reviewing and revising the PRC transaction documents, as well as attending negotiations. This project involved a complex duel shareholding structure at Cayman level and PRC level, and was ranked by SINA as one of the top 10 investment and financing events in the China healthcare industry in 2017.
PAG’s Investment in Rongchang Pharmaceuticals
JunHe represented PAG in its successful RMB 1 billion financing for Rongchang Pharmaceuticals Ltd. Rongchang Pharmaceuticals Ltd. is a modern pharmaceutical enterprise integrating the R&D, production, and sales of modern Chinese medicine and biological drugs. Its ADC new anti-tumor drug RC48 was the first ADC drug in China to be approved by the former China Food and Drug Administration to enter into clinical trials for human subjects.