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ChinaBio Today
All content provided by: ChinaBio® Today Published on November 21, 2015

CFDA Begins Reform of China Drug Approval Process

Industry Insights

The CFDA has issued new policies to reduce the very long waiting times for approvals -- both for clinical trial and marketing approvals (see story). According to a recent Ropes & Gray internet posting, the new rules: 1) expand the categories of new drugs that qualify for fast-track approval; 2) simplify the clinical trial approval procedure; 3) allow innovative companies to file for approval without owning their own drug manufacturing facility; and 4) classify drugs that are approved outside of China as generics for China approval.

Over the next five years, China's spending on medicines will grow at a 6-9% CAGR, with a total drug spend of $150-$180 billion in 2020, according to a forecast released by healthcare consultancy IMS (see story). Just one year ago, IMS predicted that China's drug market would grow at a 10-13% CAGR over the same time period. China's expected economic slowdown is part of the reason for the revision, but IMS also thinks that, as more of China's citizens gain access to medicines, there is a smaller driver for future growth. (Editor's Note: ChinaBio believes there is still significant upside for western drugs in China). 

Deals and Financings

Nantong Jinghua Pharma (SHZ: 002349) struck a $50 million deal to acquire China rights for two anti-cancer monoclonal antibodies from Kadmon Corporation of New York (see story). The molecules, both of which are in preclinical development, are fully human anti-VEGFR2 and anti-PD-L1 mAbs. Jinghua also in-licensed rights to Kadmon's mAb discovery technology. Jinghua made a $10 million equity investment in Kadmon and agreed to a $40 million milestone package plus a 10% royalty on sales. 

Lee's Pharma (HK: 950) has in-licensed Greater China and Southeast Asia rights to a potential liver cancer treatment from Tragara Pharma of San Diego (see story). The drug is Tragara's oral multi-kinase inhibitor, TG02, which is currently in Phase Ib trials in the US. Lee's participated in Tragara's $13 million capital raise and made an upfront payment. Tragara is eligible for milestones and tiered royalties on future sales, while Lee’s will be responsible for all development and commercialization costs. 

ianjin Tasly Holding Group (SHA: 600535) and Taikang Life Insurance Company launched a $784 million China healthcare fund (see story). The fund will invest in hospitals, medical equipment, diagnostics, nutritional products and projects in remote healthcare, mobile Internet-based services and healthcare data -- everything except drugs. Tasly Holding is the parent of Tasly Pharma, a company that makes TCM products, chemical drugs and healthcare products. 

LYFE Capital closed its first fund, which will invest in China healthcare growth stage companies, with $298 million (see story). The funds are comprised of US$210 million and CN¥555.  The company said the LYFE Capital Fund I would make equity investments in China healthcare companies starting from early growth stage. The company will seek to identify companies with marketed products that want to expand internationally. LYFE has an office in Shanghai. 

Company News

BeiGene, a Beijing novel cancer drug developer, received the 2015 R&D Achievement of the Year award from BayHelix (see story). BeiGene won the award for dosing the first China-originated anti-PD-1 mAb in humans, securing US FDA approval of its IND, clearance of its BTK inhibitor (BGB-3111), dosing the first patient in China with its novel RAF dimer inhibitor (BGB-283), and securing over $170 million in financing from China and US institutional investors. BayHelix is an association of global life science leaders of Chinese heritage. 

Fresenius Medical Care, a German company focused on renal care, opened its new China Design Center in Shanghai's Caohejing Hi-Tech Park (see story). Fresenius makes equipment for renal care and operates dialysis clinics globally. The company will invest $100 million over the next years in the facility, which it characterized as an R&D center, to develop high-quality basic renal equipment at an affordable cost for China and Asia. 

The Shenzhen Cell Bank and Shenzhen (Beike) Regional Cell Preparation Center, built by Beike Biotech Co., signed a cooperation agreement with 11 Shenzhen hospitals to form a cell therapy translation base (see story). The base will focus on clinical application of regenerative medicine technology and accelerate the development of individualized cell therapy treatments. 

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ChinaBio® Today is the most widely read source for news and insights on the rapidly evolving life science industry in China. From our offices in Shanghai and California, we provide daily news, commentary and analysis on China life science companies and industry events, as well as global issues affecting the China life science market.
Our parent organization, ChinaBio LLC, provides consulting services to assist Western companies seeking partners, technology or funding in China, as well as China companies seeking products or partners in the West. We are also well known for our conferences in China, including our ChinaBio Partnering Forum, which attracts over 700 attendees annually, our ChinaBio Investor Forums, connecting investors and innovation, and our invitation-only ChinaBio Leadership Retreat.