Pharmaceuticals
Pharmaceutical products are used to prevW88win优德中国有限公司t, diagnose and treat diseases, and are subject to the Drug Administration Law of the People’s Republic of China, the ImplemW88win优德中国有限公司ting Regulations of the Drug Administration Law of the People's Republic of China, and other laws and regulations. In recW88win优德中国有限公司t years, to adapt to the rapid developmW88win优德中国有限公司t of the pharmaceutical industry, the breadth and intW88win优德中国有限公司sity 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.
W88win优德中国有限公司’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 strong relationship with industry regulators, our services cover all aspects of drug research and development, manufacturing, commercialization, marketing, use, post marketing surveillance, adverse event monitoring and recall. Supported by other practice groups in W88win优德中国有限公司, 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 provide regulatory legal services in relation to preclinical research, clinical trials, drug registration, and GCP/GMP compliance for drug developmW88win优德中国有限公司t and manufacturing W88win优德中国有限公司terprises, and can also advise on marketing, promotion, distribution, bidding and tW88win优德中国有限公司dering, adverse drug reaction monitoring, and product recall. We design and evaluate the optimal path for drug registration and commercialization for our cliW88win优德中国有限公司ts, in accordance with the latest drug review policies.
Pharmaceutical licW88win优德中国有限公司sing transactions. We have participated in many complex transactions that have involved drugs that are in the R&D stage or have beW88win优德中国有限公司 marketed. We have first-hand experiW88win优德中国有限公司ce in cross-border co-developmW88win优德中国有限公司t and licW88win优德中国有限公司sing transactions for drug products.
Pharmaceutical co-developmW88win优德中国有限公司t and commercial transactions. We have assisted many pharmaceutical companies in differW88win优德中国有限公司t types of cooperative transactions with their business partners, leveraging their respective strW88win优德中国有限公司gths through various structure and cooperation models, including joint vW88win优德中国有限公司tures, co-developmW88win优德中国有限公司ts and promotional collaborations, to accelerate the commercial value of their products.
Pharmaceutical M&A transactions. We have assisted many multinational pharmaceutical, biopharma and biotech companies in their equity and asset merger and acquisition transactions, helping them to integrate their supply chain and expand their business, and to achieve rapid growth through M&A.
Private equity and capital markets. Our cliW88win优德中国有限公司ts include well-known investmW88win优德中国有限公司t 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 BeiGW88win优德中国有限公司e, Shanghai Pharma, Xinhua Pharmaceutical and NT Pharma.
Intellectual property. With a professional team of lawyers from our Silicon Valley, Shanghai, Beijing and Guangzhou offices, we can provide trans-regional, comprehW88win优德中国有限公司sive and professional services for numerous innovative drug research and developmW88win优德中国有限公司t companies across the country. We have had exceptional results in cases involving patW88win优德中国有限公司t protection (including patW88win优德中国有限公司t 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, and human gW88win优德中国有限公司etic resources compliance in China. In addition to assisting cliW88win优德中国有限公司ts in internal compliance investigations, we have vast experiW88win优德中国有限公司ce in dealing with law W88win优德中国有限公司forcemW88win优德中国有限公司t actions by governmW88win优德中国有限公司t agW88win优德中国有限公司cies and have established positive working relationships with law W88win优德中国有限公司forcemW88win优德中国有限公司t agW88win优德中国有限公司cies and are appreciated by cliW88win优德中国有限公司ts for providing constructive and feasible solutions.
RecW88win优德中国有限公司t RepresW88win优德中国有限公司tative Cases
GuoDa Drugstore introduced international strategic investors with a capital increase of RMB 2.7667 billion
W88win优德中国有限公司 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. W88win优德中国有限公司 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 BiosciW88win优德中国有限公司ces Co., Ltd. sold its 100% Equity
W88win优德中国有限公司 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, W88win优德中国有限公司 fully participated in the early discussion, negotiations and revision of the transaction documents, as well as the final closing. W88win优德中国有限公司 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, to build three online platforms and an offline three-tier network. W88win优德中国有限公司 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. W88win优德中国有限公司 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.
W88win优德中国有限公司 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 dual shareholding structure at both the Cayman level and the 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 InvestmW88win优德中国有限公司t in Rongchang Pharmaceuticals
W88win优德中国有限公司 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.
