SHANGHAI, June 6 (Reuters) - Novo Nordisk is facing the

prospect of intensifying competition in the promising Chinese

market where drugmakers are developing at least 15 generic

versions of its diabetes drug Ozempic and weight loss treatment

Wegovy, clinical trial records showed.

The Danish drugmaker has high hopes that demand for its

blockbuster drugs will surge in China, which is estimated to

have the world's highest number of people who are overweight or

obese.

Ozempic won approval from China in 2021 and Novo Nordisk

saw sales of the drug in the greater China region

double to 4.8 billion Danish Krone ($698 million) last year. It

is expecting Wegovy to be approved this year.

But the patent on semaglutide, the active ingredient in both

Wegovy and Ozempic, expires in China in 2026. Novo is also in

the midst of a legal fight in the country over the patent.

An adverse court ruling could make it lose its semaglutide

exclusivity even sooner and turn China into the first major

market where it is stripped of patent protection for the drugs.

Those circumstances have drawn several Chinese drugmakers to

the fray. At least 11 semaglutide drug candidates from Chinese

firms are in the final stages of clinical trials, according to

records in a clinical trial database reviewed by Reuters.

"Ozempic has witnessed unprecedented success in mainland

China ... and with patent expiry so close, Chinese drugmakers are

looking to capitalise (on) this segment as soon as possible,"

said Karan Verma, a healthcare research and data analyst at

information services provider Clarivate.

Front-runner Hangzhou Jiuyuan Gene Engineering has already

developed one treatment that it says has "similar clinical

efficacy and safety" as Ozempic and applied for approval for

sale in April. The company has not published efficacy data and

did not respond to a request for the information.

The company said in January that it expected approval in the

second half of 2025, but cautioned that it will not be able to

commercialise the drug before Novo's patent expires in 2026,

unless a Chinese court makes a final ruling that the patent is

invalid.

The Danish company's semaglutide patent is expiring in China

far ahead of its expiry in other key markets such as Japan,

Europe and the U.S. Analysts attribute variations in patent

expiry timelines to term extensions Novo has won in specific

regions.

Even more pressing for Novo is a 2022 ruling by China's

patent office that the patent is invalid for reasons related to

experimental data availability, which the company has

challenged.

China's top court said it was not able to say when verdicts

are likely ready.

A Novo spokesperson said it "welcomes healthy

competition" and was awaiting a court decision on its patent

case. The spokesperson did not answer follow-up queries on the

matter.

Other Chinese drugmakers who are running the final stages of

clinical trials for Ozempic generics include United Laboratories ( ULIHF )

, CSPC Pharmaceutical Group ( CHJTF ), Huadong Medicine

and a subsidiary of Sihuan Pharmaceutical Holdings

Group ( SHPHF ).

CSPC said in May it expected approval for its semaglutide

diabetes drug in 2026.

Brokerage Jefferies estimated in an October report that

semaglutide drugs from United Laboratories ( ULIHF ) will be launched for

diabetes in 2025 and obesity in 2027. United Laboratories ( ULIHF ) did

not respond to a request for comment.

IMPACT ON PRICES

The number of adults who are overweight or obese in China is

projected to reach 540 million and 150 million, respectively, in

2030, up 2.8 and 7.5 times from 2000 levels, according to a 2020

study by Chinese public health researchers.

If shown to be as safe and effective as Novo's, Chinese

drugmakers' products will increase competition and bring down

prices, analysts say.

Goldman Sachs analysts estimated in an August report that

generics could lead to a price reduction of around 25% for

semaglutide in China. The weekly Ozempic injection costs around

$100 for each 3mL dose through China's public hospital network,

Clarivate's Verma said.

Novo acknowledges the intensifying competition.

"In 2026 and 2027 we might see a few more players showing up

due to the clinical trials" in progress, Maziar Mike Doustdar, a

Novo executive vice president, told investors in March,

referring to the China market.

But he also questioned the capability of some of the

players to provide meaningful volumes, adding "we will watch it

as we get closer".

Novo also faces competition from internationally well known

firms including Eli Lilly ( LLY ) whose diabetes drug Mounjaro

received approval from China in May. HSBC analysts expect

China's approval this year or in the first half of 2025 for

Lilly's weight loss drug with the same active ingredient.

Eli Lilly ( LLY ) did not reply to a request for a comment on

Chinese approval of the drug, which in the U.S. is called

Zepbound.

Supplies of both Wegovy and Zepbound remain constrained but

the companies have been increasing production.

Zuo Ya-Jun, general manager of weight loss drugmaker

Shanghai Benemae Pharmaceutical, said a product being

competitive would depend on distinguishing features such as

efficacy, durability of the treatment and a company's sales

abilities.

"It will be a market with fierce competition, but who will

be (the leader) is hard to say," she said.