*

Bangladeshi drugs made with Ozempic key ingredient shipped

to 12

markets, including U.S. and Britain - data

*

Novo Nordisk says it cannot vouch for safety of unapproved

semaglutide-based products

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Patent exemptions allow companies in Bangladesh and Laos

to

produce semaglutide drugs

*

Some Chinese ingredient makers have started to produce

semaglutide

By Andrew Silver

SHANGHAI, Nov 1 (Reuters) - Just over a year ago, New

Zealand customs officials started to intercept batches of

injectable medications labelled Fitaro and Orsema, developed by

a little-known Bangladeshi drugmaker, Incepta Pharmaceuticals.

The injectable pens, 14 of which were seized at the border,

contained semaglutide, a patented substance that helps control

blood sugar levels and appetite and is the key ingredient in

Novo Nordisk's blockbuster drugs Ozempic and Wegovy,

according to data from New Zealand's medicines regulator

Medsafe, reviewed by Reuters.

The Incepta drugs are part of an Asia-based supply chain

manufacturing and exporting cheaper copies of Ozempic across the

world, Reuters has found, driven by a spike in global demand for

the drug.

Ozempic was developed for type 2 diabetes but its active

ingredient semaglutide is effective in promoting weight loss.

The market for such weight-loss treatments, which Novo Nordisk

is targeting with anti-obesity treatment Wegovy, is forecast to

reach $150 billion by the early 2030s.

According to a Reuters review, at least 106,000 packs of

semaglutide-based medicines made in Asia by Incepta have been

shipped to 12 foreign markets including countries like the

United States and Britain where Ozempic is protected by patents.

Incepta did not respond to multiple requests for comment

about Fitaro and Orsema, which are approved for sale in

Bangladesh, according to public records and information provided

by a local regulatory official. The official with the

Bangladesh Directorate General of Drug Administration, who

declined to be named because he was not authorized to speak to

the media, said Bangladeshi regulators had given Incepta

permission to export Fitaro or Orsema but only provided it had

won approval from receiving countries. The injectable pens,

which are not authorised for use in New Zealand, were referred

to Medsafe between August 2023 and May 2024 and destroyed, data

from the regulator showed.

Medsafe told Reuters the Fitaro and Orsema batches that were

destroyed appeared to be for personal use but did not comment on

whether the medicines carried any health risk.

"Medicines that have been imported from overseas will not have

been assessed and approved by Medsafe, so carry a significant

risk as there is no assurance they have been made to an

acceptable level of quality," the regulator added in response to

a Reuters query about imports of semaglutide-based drugs.

Reuters has previously reported that semaglutide drugs from

Bangladesh were sold on India-based online marketplace

IndiaMART. The latest reporting shows that the international

distribution of semaglutide drugs not made by Novo Nordisk is

much wider.

The data surveyed by Reuters came from pharmaceutical regulators

in Australia, Brazil, New Zealand and the United States;

information from a commercial customs data provider for Kenya,

Uzbekistan, Venezuela, Hong Kong and the United Arab Emirates;

and records of intercepted drugs from Britain, Switzerland and

Ireland.

In addition, an interview with a trade show exhibitor, a review

of data from the commercial customs data provider, and from

Brazil's Justice Ministry showed that six little-known

companies, four of which are based in Asia, manufacture

semaglutide-based medicines and that their products are shipped

overseas.

At least three of these firms imported the key ingredient

from China and at least one of their products was promoted

online and in person outside the country of origin, according to

the commercial customs data provider's data, an interview with

an employee at Chinese supplier Nanjing Hanxin Pharmaceutical

Technology, and a website and social media app reviewed by

Reuters.

These players take advantage of global patent exemptions allowed

for less developed countries and instances of loose patent

enforcement in countries including in China, the Reuters review

shows.

Novo Nordisk told Reuters it is the only approved

manufacturer of semaglutide globally, and it could not vouch for

the safety or effectiveness of products claiming to contain

semaglutide made by other manufacturers.

Even though Novo Nordisk's semaglutide is protected by

international licences, countries like Bangladesh and Laos,

classified as least developed nations by the United Nations,

enjoy exemptions from industry patent rules.

The Danish firm, which has quickly become Europe's most

valuable company with a market capitalisation of around $400

billion, states on its website that it does not enforce patents

in less developed countries. Given the frenzied demand for

Ozempic, the financial impact of possible patent infringement on

Novo Nordisk is currently limited. "Illegal versions of the

drugs today do not cannibalize Novo's sales given they are

selling every dose they can produce," said Nicholas Anderson,

portfolio manager and managing director at global asset

management firm Thornburg Investment Management, which owns Novo

Nordisk stocks.

However, such copies are raising healthcare concerns. Medicines

regulators in at least six countries including the U.S., Britain

and Ireland have rejected, destroyed or seized some of Incepta's

semaglutide-based drugs, according to drug regulator records and

responses from regulators to Reuters' queries. In one case,

unauthorised semaglutide was recalled in South Africa in

December, because of potential health risks, according to a

public notice posted in January by the local medicines

regulator. The authority told Reuters the ingredient was sourced

from a supplier in China not authorised to produce the

ingredient in Ozempic, without providing more details.

"The semaglutide, said to be found in this unauthorised

substance, may contain unexpected impurities or degradation

products which can have unknown effects on patients," the notice

said.

Reuters found no evidence that these products would have caused

any harm to patients, but their spread could add to public

health concerns about a sector also threatened by fake

Ozempic.

PARALLEL SUPPLY CHAIN

The official with the Bangladesh Directorate General of Drug

Administration said Orsema was approved in Bangladesh and

considered safe. Fitaro is also approved for sale, public

records show.

A clinic in the capital Dhaka has prescribed Incepta's Fitaro

injector pens to around 20 patients, all foreigners based in

Bangladesh, according to a manager, who declined to be named or

identify the clinic due to the sensitivity around the treatment.

"When patients found out that Fitaro was available in

Bangladesh at a maximum monthly cost of around $60 a month,

(against) $650 in the U.S. (for Wegovy), they didn't seem

particularly focused on who the manufacturer was," the manager

said. In Laos, semaglutide-based medicines can only be

legally produced and distributed for national use, Davone

Duangdany, director of the drug and medical device control

division within the Laos health ministry, told Reuters. But

some Chinese companies have been promoting Laos-produced

semaglutide tablets in China, where Novo Nordisk's patent is due

to expire in 2026 or earlier if it loses a legal challenge. At

an industry exhibition in Shanghai in June that Reuters

attended, ingredient manufacturer Nanjing Hanxin Pharmaceutical

Technology displayed boxes of Semagcare semaglutide tablets,

manufactured by Laos-based Boten Elemento Pharma.

Abdu Zoghbi, business development director of Nanjing Hanxin,

told Reuters that his company provides semaglutide to the

Laos-based drugmaker.

"We don't know which countries (Semagcare is sold to) but

we are doing the promotion because once they sell more, we sell

more API (active pharmaceutical ingredient) to them," he told

Reuters when asked about why it was showcasing the drug at the

expo.

Boten Elemento Pharma's Semagcare tablets appeared on sale

on a Chinese language website and also a Chinese social media

app, according to a Reuters review. Sales of semaglutide by a

Chinese company could amount to an infringement of Novo

Nordisk's China patent, said Frank Yang, senior associate at

Marks & Clerk Intellectual Property Agency in reply to a Reuters

query about possible licences breaches.

A spokeswoman for Novo Nordisk said the company does not

produce the ingredient in China.

The China National Intellectual Property Administration

declared the Danish drugmaker's patent invalid in September

2022. However, Novo Nordisk successfully appealed this decision.

Novo Nordisk told Reuters it is now awaiting a court

decision on a subsequent appeal.

"We hope to see a continued trend in supporting and protecting

innovation during patent invalidation proceedings," a Novo

Nordisk spokesperson said in response to questions about whether

it was enforcing its patent in China.

Contacted by Reuters by fax, the Chinese medicine regulator did

not reply to queries about quality controls at the Chinese firms

making semaglutide.

A second Chinese firm, Shanghai Longtide Biotechnology,

which described itself as a biotechnology company, also

displayed a box of Semagcare tablets at its booth at a separate

trade show in Shenzhen that Reuters also attended. Reuters

contacted Boten Elemento Pharma through its website but the

company did not respond. A business registered as Shanghai

Longtide Biotechnology did not reply to requests for comment.

BENDING BOUNDARIES A third Chinese biotechnology

firm, Zhejiang Peptites Biotech, is among the suppliers of

semaglutide to Incepta, the data from the commercial customs

data provider showed. The Bangladeshi drugmaker has

imported at least 892 grams of semaglutide valued at about

$805,000 between 2020 and 2024 from mainland China and Hong

Kong, according to a Reuters calculation based on the customs

data provider's shipment data for Zhejiang Peptites Biotech and

other suppliers. Zhejiang Peptites Biotech also supplied at

least 25.6 kg of semaglutide, valued about $2.8 million, to

Russian drugmaker Geropharm in 2023 and 2024, according to

Reuters calculations based on the customs data provider's data.

Geropharm can use inventions protected by Russian patents to

provide semaglutide-based medication to the local population

without Novo's consent until the end of December, according to a

Russian government decree issued in December 2023.

The Russian company said Zhejiang Peptites Biotech's supply

of semaglutide is carried out in accordance with a contract and

it does not export the finished drug, Semavic, abroad.

However, Semavic was exported from Russia multiple times to

the breakaway Georgian region of Abkhazia, information from the

commercial customs data provider reviewed by Reuters showed.

Zhejiang Peptites Biotech did not respond to a request for

comment on shipments of semaglutide to Incepta and Geropharm.

The customs data showed that it was not only Chinese firms

supplying semaglutide: Incepta has imported the ingredient from

Swiss generic drugmaker Bachem. A spokesperson for

Bachem said it produces semaglutide for pharmaceutical companies

for research and development purposes only and declined to

comment on its relationship with Incepta. Medicines

regulator Swissmedic told Reuters Bachem was authorised to

export semaglutide, but added Swissmedic was "not supervising

patents".