Roche wins approval for cancer drug Kadcyla in fast-growing China market

* China approves import of Kadcyla drug for breast cancer

* Kadcyla surpassed $1 billion in annual sales last year

* China is Roche's second-largest market behind the United
States

By Roxanne Liu and John Miller

BEIJING/ZURICH Jan 22 (Reuters) - Roche said on
Wednesday China had approved the import of its Kadcyla drug for
breast cancer, another win for the Swiss drugmaker in its
second-biggest market where rising demand has helped drive its
increased sales and profit.

Kadcyla, which also recently won expanded approval in the
United States, Canada and Europe for more breast-cancer
patients, is an antibody-drug conjugate (ADC), a class of
therapies that combine monoclonal antibodies with cytotoxic
chemical that in 2019 picked up momentum with a record number of
U.S. approvals.

Over a decade, China has gone from Roche's 10th biggest
market to its second-largest behind the United States, with 4.5
billion Swiss francs ($4.5 billion) in 2018 sales as more of its
advanced medicines won Chinese regulators' favour. The pace has
accelerated, with growth in China topping 50% over the first
nine months of 2019, about double 2018's rate.

Roche reports 2019 results next week, and analysts are
watching to see whether the pace of Chinese sales growth can be
maintained.

Kadcyla, like other ADCs, a type of treatment that combines
cancer-tracking proteins with powerful cell toxins, are getting
a fresh start as multiple drugmakers including GlaxoSmithKline
test a record number of new compounds in people. That's
after some experimental ADCs failed due to the complexity of
pairing the right antibody with an appropriate toxic agent.

Kadcyla, approved in 2013 for breast cancer, surpassed $1
billion in annual sales last year, becoming the first ADC to hit
blockbuster status.

Also known as ado-trastuzumab emtansine, Kadcyla is approved
in China as an adjuvant treatment, or after surgery, in people
with HER2-positive early breast cancer who have residual
invasive disease after neoadjuvant taxane and treatment based on
Herceptin, another Roche drug, the company said in a statement.

Roche's breast cancer arsenal, including Kadcyla and
Herceptin, could be facing strong competition, with biosimilar
copies of Herceptin now on the market and December's U.S.
approval of Daiichi Sankyo's and AstraZeneca's
Enhertu, another ADC drug, well ahead of schedule.

Kadcyla was granted priority review status in June last year
by China's National Medical Product Administration, official
records show.

Other ADC products, including Roche's Polivy, GSK's
Belantamab mafodotin and Abbvie's Telisotuzumab
vedotin, filed applications for clinical trials in China last
year. GSK's drug just won priority U.S. Food and Drug
Administration review for multiple myeloma this week, while
Polivy won U.S. approval last year for lymphoma.
(Reporting by John Miller in Zurich and Roxanne Liu in Beijing;
editing by David Evans)