Chinese-made new drugs big hit overseas

 Pharmaceutical sector spurred by global market boom

"The surge in overseas expansion of domestic innovative drugs highlights the enhanced innovation capabilities of China's biopharmaceutical sector

Employees examine drug samples at a laboratory in Shenyang, Liaoning province, in May.

 [Photo/Xinhua]

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With more Chinese-developed innovative drugs entering both US and European markets, China's pharmaceutical sector is showing escalating prowess in innovation and global market penetration, said industry experts.

"This (entering the European market) is a significant milestone. Fruquintinib is the first product approved in Europe completed by our research and development engine," said Su Weiguo, CEO and chief scientific officer of Shanghai-based biopharmaceutical company Hutchmed.

Su added that the drug is already improving treatment prospects in the United States and China, and the company is looking forward to extending its impact to European market.

Su's statement came after the company announced last month that its independently developed antitumor drug Fruquintinib received approval from the European Commission for use in the treatment of metastatic colorectal cancer.

Following the drug's US market debut in November, the milestone marks its second entry into a major global market within seven months.

In November, the Chinese-made new drug was approved by the US Food and Drug Administration, with the first prescription issued within 48 hours of approval, Hutchmed said. According to data from the company's overseas commercialization partner Takeda, Fruquintinib's sales in the US market exceeded $50 million in the first quarter.

The innovative drug is also in the process of being approved for sale in other global markets, such as Japan, with a focus on enlarging its global footprint and reaching out to more patients worldwide, said Hutchmed in a recent statement.

In a related development, Hangzhou, Zhejiang-based Yifan Pharmaceutical announced in March that its innovative product, Ryzneuta, also received approval for sale in the European market.

Previously approved by the US FDA in November for treating chemotherapy-induced neutropenia, the approval marks this year's first innovative drug approval for a Chinese pharmaceutical company in a foreign market.

Last year was widely recognized as a significant watershed for Chinese innovative drugs that aim to go global, with the number of "license-out" deals surpassing "license-in "ones for the first time.

According to data from online pharmaceutical platform Pharmacube, there were about 70 out-licensing deals in China in 2023, up 32 percent from 2022, with a total transaction value of over $46.5 billion, up 69 percent from the previous year.

Out-licensing in the pharmaceutical industry is a practice where a company grants another foreign organization the rights to use its product, technology or intellectual property. It allows the licensor to enter new markets through the licensee's established presence. In-licensing, on the other hand, allows the licensee to expand its product portfolio and access innovative technologies without having to develop the product or technology in-house.

In the first half of this year, the enthusiasm for "going global "among domestic innovative pharmaceutical companies has remained high. According to a report by Chinese media Yicai, as of June 30, there were approximately 30 out-licensing deals by innovative Chinese drugmakers, with a transaction value of over $10 billion, significantly more than a year earlier.

"The surge in overseas expansion of domestic innovative drugs highlights the enhanced innovation capabilities of China's biopharmaceutical sector and reflects international regulatory bodies' recognition of China's drug innovation," said Yu Meng, deputy director of the information department at the China Chamber of Commerce for Import and Export of Medicines and Health Products.

Yu said commercialization serves as the major reason for Chinese pharmaceutical companies to target foreign markets, as lucrative pricing of innovative drugs abroad presents a vast profit potential and prompts some globally competitive companies to explore overseas markets for higher returns.

In fact, due to the significant market size of innovative drugs, the US and European markets have become prime targets for such drugmakers. The US accounted for over half of global innovative drug sales in 2021, with Europe at 16 percent, while China stood at merely 3 percent, far below that of developed countries, according to a report by consultancy Market Monitor.

In order to strengthen policy support for the growth of the innovative drug sector, on July 5, the State Council, China's Cabinet, issued a guideline that supports improved price management, medical insurance payments, commercial insurance coverage, allocation and usage, as well as investment and financing in the sector.

Specifically, efforts will also include improving scientific and technological resource allocation, strengthening fundamental research in new drug development and solidifying the R&D foundation for China's innovative drugs, according to the guideline.

Domestic pharma firms' enthusiasm for going global driving business abroad

Technicians run drug experiments at a pharmaceutical company's lab in Haikou, Hainan province, in May. [SU BIKUN/FOR CHINA DAILY]

"I see there are a lot of companies in China that have big potential to develop global-level new drugs. For example, the number of drugs the country is running for clinical trials is massively bigger than other countries in Asia," said Chris Shim, general manager for Asia R&D and quality at US cloud-based pharmaceutical software company Veeva Systems.

With its enormous domestic market size, sufficient talent supply and large number of biotech and biopharma players, China's pharmaceutical industry is endowed with great potential to witness an increasing number of global-level innovative drugmakers, Shim said.

He added that in order to better adapt to local market conditions during their global outreach, Chinese companies are setting up concise strategies based on different market compliance issues and business performances, with a focus on the usage of cutting-edge technologies such as cloud platforms and artificial intelligence.

"Take cooperation ecosystem, for example. If Chinese companies want to manage different partners and patient dynamics abroad, they'll have to manage all the data and solutions across different countries, where lie cultural and regulatory differences and other kinds of complexities," he said, adding that digitalization can facilitate cross-regional communication and operation process to a large extent.

Shim's view is echoed by Yang Bin, clinical operations vice-president at Hutchmed, "The digitalization of overseas data collection, analysis and management ensures the timeliness of our data processing and analysis. For example, clinical data might contain some anomalies, but through a comprehensive digital management system, we can promptly detect and address these issues, ensuring the overall quality of the experiments.

"It can be said that the success of approvals in the US and Europe markets can't be separated from the application of a fully digitalized system."

In addition, Shim mentioned the role of AI in facilitating the going-global process.

"AI is helping people improve their productivity by eliminating routine jobs. For example, the documentation process of clinical trials can involve a lot of human work of writing, uploading, scanning and analyzing, but now all of them can be done by AI by simply taking a picture and AI will take care of the rest. AI is going to be the key differentiator for industry players," he said.

  

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How dangerous are India’s generic drugs? Very

 

India relies on the weak oversight of developing countries that make up the bulk of its exports – that’s how it can continue to push substandard and often deadly medicines there. — Bloomberg

 

FOR a nation that seeks to claim the mantle of “pharmacy to the world,” India is scandalously short on regulatory oversight.

In the last six months, its generic cough syrups have killed dozens of children, its eye drops have caused blindness and its chemotherapy drugs have been contaminated.

The children who died – mostly under the age of five years – were given Indian-made over-the-counter products contaminated with industrial solvents and antifreeze agents that are fatal in even small amounts.

The eye drops that contained extensively drug-resistant bacteria? So far 68 patients across 16 US states have been affected. Three people died, several had to have their eyeballs removed, some went blind, the Centres for Disease Control and Prevention reported on March 21.

The Indian company, Global Pharma Healthcare, issued a voluntary nationwide recall for the drops. India is the largest provider of generic medicines, producing 20% of the world’s supply, according to the government’s Economic Survey.

Its US$50bil (RM220bil) drug-manufacturing industry exports medicines to over 200 nations and makes 60% of all vaccines. It boasts “the highest number” of US Food and Drug Administration or FDA-compliant plants outside America, and indeed, some of its generic pharmaceutical companies produce high-quality medicines.

That may well provide consumers with a level of comfort, but history suggests it is unwise to trust that feeling.

The latest drug recalls just add to a long line of scandals that have tainted the sector.

In 2013, a US subsidiary of major Indian drug manufacturer Ranbaxy Laboratories Ltd pleaded guilty to US federal criminal charges and agreed to pay US$500mil (RM2.2bil) lion for selling adulterated generic drugs, fabricating data, and committing fraud. Serious flaws in the FDA compliance regime allowed these breaches to go undiscovered, until a years-long investigation laid bare the endemic corruption.

A generic drug made in India and modelled on Lipitor sold in the US to treat high cholesterol, for example, was contaminated with shards of blue glass, as journalist Katherine Eban documented in her book, Bottle of Lies: The Inside Story of the Generic Drug Boom. Her book draws in part on the experience of whistleblower Dinesh Thakur, who worked at Ranbaxy.

You would think such a damning indictment would prompt India to develop a safer, better pharmaceutical oversight regime. Think again.

The systemic fraud exposed by the investigation – where data was routinely falsified to fool inspectors, increase production and maximise profit – did not result in a regulatory overhaul.

Still, a two-day “brainstorming session” held in February appeared to acknowledge the system’s inherent weaknesses, with Health Minister Mansukh Mandaviya telling participants India needed to “move from generic to quality-generic drugs.”

Discussions involved “how to make the country’s drugs regulatory systems transparent, predictable and verifiable,” according to a health ministry media release.

Consumers shouldn’t hold their breath, though. A national law on drug recalls has been under discussion since 1976 without resolution, and the government – at least publicly –remains in denial: Since the Ranbaxy scandal, Thakur has campaigned for the reform of India’s main regulator, the Central Drugs Standard Control Organisation, and, with lawyer T. Prashant Reddy, has written his own book, The Truth Pill: The Myth of Drug Regulation in India, which was published in October.

They note that adulterated Indian drugs aren’t just killing children in developing-world export markets like Gambia and Uzbekistan. They’re also killing children at home: In 2019, at least 11 infants died in the state of Jammu because of cough syrup containing diethylene glycol. 

The World Health Organisation (WHO) sent alerts in October and January, asking for the cough medicine to be removed from the shelves. (It also issued a warning last year for cough syrups made by four Indonesian manufacturers sold in that country, where 203 children died in similar circumstances.)

Maiden Pharmaceuticals, whose medicines were sold in Gambia and linked by the WHO to the deaths of at least 70 children, has denied wrongdoing. And India’s regulator rejected the WHO’s findings, saying no toxic substances had been found in samples taken from Maiden’s plant. 

It shouldn’t have taken more deaths for Prime Minister Narendra Modi’s administration to act. The red flags have been there for years. What’s lacking is political will, and transparency. The FDA publishes different reviews of new drug applications on its website, along with detailed notes. 

So why does contamination with such deadly substances occur so regularly?

“The simple answer is that Indian pharmaceutical companies quite often fail to test either the raw materials or the final formulation before shipping it to market,” Thakur said.

India relies on the weak oversight of developing countries that make up the bulk of its exports – that’s how it can continue to push substandard and often deadly medicines there.

In the absence of a global framework for pharmaceutical safety, what can be done to make the generic drugs that consumers around the world have come to rely on safer and effective?

For a start, the WHO’s prequalification programme, which facilitates the purchase of billions of dollars’ worth of medicines through international agencies such as Unicef, must be overhauled. Then there’s the question of holding these companies to account for the harm they cause inside and outside India via legal avenues and victims’ compensation. — Bloomberg 

- Ruth Pollard is a Bloomberg Opinion columnist. The views expressed here are the writer’s own.

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China makes steady progress towards coronavirus vaccines to market

 

Inactivated COVID-19 vaccine CoronaVac produced by Chinese vaccine developer Sinovac Photo: Courtesy of Sinovac

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 Chinese vice premier Sun Chunlan stressed a scientific and rigorous preparation is required for the mass production of Chinese-developed COVID-19 vaccines during an inspection tour of vaccine production lines of some leading manufacturers in Beijing on Wednesday, the same day the UK became the first Western country to approve a coronavirus vaccine for widespread use.

Sun and State Councilor Wang Yong visited the National Institute for Food and Drug Control, and two leading vaccine producers Sinovac, National Vaccine & Serum Institute under Sinopharm in Beijing, the Xinhua News Agency reported late Wednesday.

The visit was seen as a prelude for the vaccine coming to market in a rigorous and scientific manner. Russia and the UK announced on Wednesday they will start mass vaccinations against the coronavirus next week.

Sun and Wang learned about COVID-19 vaccine research, visited production plants and checked preparation work, and fully affirmed the achievements of the vaccine developers.

Fourteen vaccines using five technology methods are in clinical trials and five vaccines are undergoing phase Ⅲ clinical trials. Emergency use, production preparation and other work are proceeding in an orderly manner.

Sun called for scientific and rigorous phase Ⅲ clinical trials to carry out review and approval work in strict accordance with laws, regulations and internationally recognized technical standards to ensure the safety and effectiveness.

She required Chinese companies prepare for mass production, strictly comply with laws, regulations, procedures and requirements on quality supervision and biosafety, improve the traceability system for vaccines, punish illegal activities for creating a favorable market environment.

Sun said it's necessary to formulate a vaccination distribution plan before the vaccines are made available to the public. The emergency use of the vaccine in high-risk groups, such as port workers and front-line supervisors, will be completed by the end of 2020, she said.

The UK's approval of Pfizer's coronavirus vaccine on Wednesday paved the way for widespread uses of the vaccine. The first doses are already on their way to the UK, with 800,000 due to arrive in the coming days, Pfizer said.

Analysts said the UK and Russia's quick approval for widespread use of vaccine is mainly in response to new outbreaks that may get worse during the coming winter.

China is very likely to introduce its first officially approved vaccine for mass use in December, but whether it would be approved only for limited use is still under discussion, a Beijing-based immunological professor who asks not to be named told the Global Times.

The first vaccines to get approval are likely the inactivated vaccine candidates from either Sinovac or state-owned Sinopharm, said the professor, noting that other frontrunner candidates such as recombinant adenovirus vector vaccine would be slightly behind or approved for emergency use first.

The Global Times learned from the Sinovac's Brazilian partner Butantan Institute which is carrying out the phase Ⅲ clinical trials of the inactivated vaccine CoronaVac that the data from the trials have been sent to the Brazilian National Health Surveillance Agency. Sinovac told the Global Times that analysis of the clinical data will take some time.

Compared to China, vaccines are more urgently needed in the West, said a Shanghai-based vaccine expert. "The epidemic battle left many Americans desperate, let's hope President-elect Joe Biden will take human rights seriously and not follow in Trump's footsteps."

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