SHANGHAI – 2013 was another banner year for biopharmaceutical licensing deals in China, with inbound agreements continuing to grow and outbound transactions showing up noticeably for the first time.

"We are seeing a lot of inbound and outbound licensing deals right now," said Lewis Ho, partner at Dechert LLP in Hong Kong and legal counsel on some of the more interesting biopharma deals of the year.

"The licensing model is more common than M&A or other types of collaborations. It works well for companies not prepared to invest or set up their own China office or Asia HQ. Instead companies partner with established players in China in clinical studies, drug registration and manufacturing," Ho told BioWorld Asia.

Looking at the numbers for all drug partnering in China, 2013 was the fourth straight year to see substantial increases in deal amounts and number of deals. It grew an astonishing 112 percent for a total value of $1 billion. Almost half of all partnering deals were licensing deals, according to Chinabio LLC.

Digging deeper into the Chinabio database, there were some 30 licensing deals in the biotech sector last year. Perhaps it's not surprising, as Greg Scott, president of Chinabio said, "licensing remains one of the easiest ways to bring products into China."

A couple of trends have emerged.

BIGGER UP-FRONT, MILESTONE PAYMENTS

Ho said Chinese companies aren't shying away from hefty up-front payments and millions more for milestones and royalties, a change from just three years ago and one that he says should just keep getting better.

"It is very encouraging to see Chinese companies are willing to take on some risk, in some ways they are hungry for new compounds and new technology. They are prepared and willing to pay well compared to other countries," said Ho.

A good example is Eddingpharm Co. Ltd., a Hong Kong-based specialty therapeutics company that paid Ablynx NV, of Belgium €2 million (US$2.7 million) up front, plus commercial milestones and tiered double-digit royalty payments for its anti-RANKL nanobody ALX-0141. (See BioWorld Today, Oct. 21, 2013.)

According to Deschert while the amount of up-front payments varies widely, upfront payments are often 10 percent of the overall deal value. Oncology and hepatitis deals usually attract the highest overall deal amounts.

TIMING IS KEY

The Eddingpharm deal although considered a typical deal in terms of size, was unusual in terms of timing, considered on the early side for China with an asset only at phase I in Europe.

Deschert said that drug candidates already approved in the U.S. or Europe will typically receive the highest up-front and total value amounts since this minimizes the R&D and regulatory risks.

"If you have a registered product in the U.S. or Europe these will be really good commodities in China," said Ho. "From that point it can take three years to get registered in China. Going from scratch it will take six years. By cutting the process timeline in half, you provide a good revenue stream much quicker for the Chinese company looking to launch new products for the market."

"The optimum time to partner is phase II in preparation for the phase III trial, and the statistics bear this out," Scott said.

But timing does not seem to bear much relation to deal valuations. According to a benchmark survey by Deschert, there is no correlation between the development stage of the licensed drug candidates and the overall deal value.

When gauging timing it is important to consider if a drug will be sold as an imported or domestic drug. For example, domestic drugs must have the manufacturing ready to supply the clinical trial process from the outset. This is a sizable front-end cost that is challenging for many innovative start-ups to tackle. Imported drugs don't have to clear this hurdle.

The same company that markets the drugs must also do the manufacturing and can't hire contract manufacturing organizations, which might explain deals such Amgen Inc. setting up a joint venture (JV) with Zhejiang Beta Pharma Co. Ltd.

Since setting up a JV is not for everyone, many biotechs find it better to bring an asset in as an imported drug and seek approval with the support of a local partner.

MOVING IN THE OTHER DIRECTION

Last year saw a few interesting outbound deals which show that China can deliver promising novel assets to the world as well.

"We are seeing a trend going the other direction with a few outbound licensing deals. This is a significant trend," noted Scott. "Prior to that almost all the deals were Western companies coming to China. We are starting to see enough innovation to stimulate outbound licensing."

One notable deal was between Les Laboratoires Servier of France and the state run, Shanghai Institute of Materia Medica (SIMM) for a novel cancer compound Lucitanib, a promising targeted drug with anti-angiogenic effects. Getting the Chinese government to agree to sell a homegrown novel asset was a big part of the challenge for Servier.

"Servier found an interesting compound in China," said Ho. "They needed diplomatic skills to persuade government institutions to out-license the China rights to a foreign company. While it is an international collaboration, to make it look more like a China deal it was signed with Servier's Chinese subsidiary and they gave up some control by co-developing with SIMM."

THE CHINA STRATEGY

While outbound deals are eye-catching they are still the minority. The majority of deals will still be inbound for China not just because the Chinese companies are looking for novel assets, but also because many biotechs are finally catching on to the China opportunity.

"For medium size international biotechs, China is just starting to become a story," said Ho. "Many companies, if they just listed in the U.S. or EU, have institutional investors asking about their China strategy. I know one CEO looking to find a partner to sign at least two licensing deals by the end of the year, or it might affect their investors."

"There is something really big going on here," Ho said. When asked if the licensing total deal values could double again next year he is confident. "I see the deal number continuing to grow, we could get to $2 billion."