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China Is Hungry for Ozempic

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发表于 2-20-2024 15:22:08 | 显示全部楼层 |阅读模式
本帖最后由 choi 于 2-21-2024 12:36 编辑

Dave Sebastian, World's Obesity Capital Is Hungry for Ozempic. Wall Street Journal, Feb 20, 2024, at page A1.
https://www.wsj.com/health/pharm ... nt-the-u-s-a7c2498c

Note:
(a) "China has more obese people than anywhere else in the world * * * There are about 200 million obese adults in China, and an additional 400 million who are overweight, according to estimates by Jefferies based on official data."
(i) "China has more obese people than anywhere else in the world"

It is the absolute number, not percentage of population.
(ii) body mass index
https://en.wikipedia.org/wiki/Body_mass_index
(section 1 History: "Adolphe Quetelet [a Belgian who developed the formula 'between 1830 and 1850'] * * * The modern term 'body mass index' (BMI) * * * was coined in a paper published in the July 1972 edition of the Journal of Chronic Diseases by Ancel Keys/ section 2 Categories: "The WHO regards an adult BMI * * * "/ section 2.2 International variations, section 2.2.5 United States: "In 1998, the US National Institutes of Health brought US definitions in line with World Health Organization guidelines, lowering the normal/overweight cut-off from a BMI of 27.8 (men) and 27.3 (women) to a BMI of 25. This had the effect of redefining approximately 25 million Americans, previously healthy, to overweight" (emphases original)
(A) Emphasis is on "adult." In section 2, there is a separate graphic for persons under 20.
(B) This Wiki page does not say when World Health Organization (WHO) adopted BMI categories.

Frank Q Nuttall, Body Mass Index; Obesity, BMI, and health: A critical review. Nutrition Today, 50: 117-128 (2015).
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4890841/

Quote:

For BMI, "the population distribution is still not Gaussian [ie, not normal distribution]. That is, it is not symmetrical but is always skewed to the right, that is, toward a higher ratio of weight (body mass) to height. For example, the distribution of BMIs in adult American men and women was determined in 1923 in 1026 individuals (Figure)."  [The first paragraph beneath the figure said that deviation to the left is not compatible with life" and dying quickly, and deviation to the right "is at least compatible with life, even though it may eventually affect long-term survival."

"In 1993, the WHO assembled an Expert Consultation Group with a charge of developing uniform categories of the BMI. The results were published as a technical report in 1995. Four categories were established * * * " (footnote omitted)

(C) Ancel Keys
https://en.wikipedia.org/wiki/Ancel_Keys
(1904-2004; "In 1930, he received his PhD in oceanography and biology from UC Berkeley")
was white.


(b)
(i) Jefferies Financial Group  富瑞
https://en.wikipedia.org/wiki/Jefferies_Financial_Group
(is "listed on the Fortune 1000"/ table: public (listed at NYSE), Founded        1979, Founders        Ian M Cumming + Joseph S Steinberg; section 2 History: "In 2013, the company [then known as Leucadia] merged with Jefferies Group and Richard Handler [of Jeffries Group ('founded by Boyd Jefferies in 1962' at Manhattan)] became chief executive officer of the [merged] company")
(ii) "Christopher Lui, head of Asia healthcare research at Jefferies"

Christopher Lui  雷宇光 is based in Hong Kong. ("Christopher has a BSc in Biochemistry and BSc in Mathematical Economics from the University of Wisconsin – Madison.": from the Web (BSc is an error: University of Wisconsin – Madison grants BS only.

(c) "In 2017, China's health commission [国家卫生健康委员会] started a campaign it named the 'three reductions and three healthy conditions,' calling for Chinese citizens to reduce their intake of salt, oil and sugar and strive for healthy oral hygiene, body weight and bones."

三减三健: 减盐、减油、减糖、健康口腔、健康体重、健康骨骼
(d) "PharmCube [医药魔方 (formed in 2015 as a subsidiary of 北京华彬立成科技有限公司] * * * Huadong Medicine [Co, Ltd 华东医药股份有限公司 (1993- ; based in Hangzhou)] * * * Innovent Biologics[, Inc 信达生物 (始于信,达于行; 2011- )], a Suzhou-based drugmaker listed in Hong Kong, in January said its first Phase 3 clinical trial of mazdutide—a GLP-1 drug for which the company has a license agreement with Eli Lilly—had met endpoints. China's National Medical Products Administration [国家药品监督管理局] * * * BrightGene Bio-Medical Technology [Co, Ltd 博瑞生物医药(苏州)股份有限公司], a Shanghai-listed pharmaceutical company"


(e) "Neither Wegovy—Ozempic's sister drug specifically made for weight management—nor Mounjaro, another drug initially developed to treat Type 2 diabetes, has been approved for weight loss in China."
(i) Wegovy and Ozempic are trade names (popularly known as brand names) for semaglutide; Mounjaro tirzepatide. Both semaglutide and tirzepatide are glucagon-like peptide 1 (GLP-1) agonist. An GLP-1 agonist works like GLP-1; a GLP-1 antagonist competes with GDP-1 to bind GLP-1 receptor but does nothing after the binding, thus working against GLP-1.
(ii) drug nomenclature
https://en.wikipedia.org/wiki/Drug_nomenclature

A drug usually has one "chemical name" (section 2), one "nonproprietary (generic) name" (section 3) and many trade names (especially after its patent run out in 20 years and many companies may produces the same chemical and sold under various trade names). For "nonproprietary (generic) name," one need only remember "United States Adopted Name" (USAN) mainly because many drugs are developed in the United States.

For example, Tylenol is a trade/ brand name for USAN acetaminophen and chemical name N-acetyl-para-aminophenol (APAP). A student in pharmacology wants to take USAN to heart.
(iii) The semaglutide and tirzepatide have different methods to modify GLP-1 (one can go to Wikipedia for these two to compare chemical structures: semaglutide has a long side arm sticking out from the center of GLP-1). Modifications is necessary because GLP-1 is inactivated by enzymes in seconds.

(f) Attached is the print version, which states, "On JD.com, a monthly dosage of Ozempic retails for around $139." Online correction says, "A pen [that costs $139 in China] contains multiple injections."
(i) Here is the prescription information from Novo Nordisk for American physicians to treat Type-2 diabetes (not for weight loss, because Novo Nordisk recommends Wegovy for that purpose):
https://www.novo-pi.com/ozempic.pdf
, whose page 1 on the left column has a sectional heading (------DOSAGE FORMS AND STRENGTHS-----) that indicates that there are three kinds of pens for subcutaneous injection: 2mg/3mL, 4 mg/3mL, or 8 mg/3mL.

The section immediately above this section is headlined (-------DOSAGE AND ADMINISTRATION-------), which says the dosage (only once a week for each of the following four dosages: 0.25 mg, 0.5 mg, 1 mg, or 2 mg.

The "(3)" or "(2.2)" only refer a reader to the table right below, to be explained in details in the following pages.
(ii) Then, there are three kinds of pens that delivers "0.25 or 0.5mg only," "1 mg only" or "2 mg only." The three kinds of pens are color-coded: red, blue or yellow, respectively.
(iii) How to adjust the first "0.25 or 0.5mg only"?

Using your Ozempic® pen
https://www.ozempic.com/how-to-take/ozempic-pen.html
-------------------------------print version
China has more obese people than anywhere else in the world, and they are increasingly turning to weight-loss drugs to solve the problem. Whether a method to modify GLP-1, say, depends on how the patent-holder writes its patent.

That is fueling a gray market of drug sellers and buyers, who have little trouble getting around China’s rules on the use of Ozempic.

Ozempic isn’t available for weight loss in the country, instead being reserved for the treatment of Type 2 diabetes. But users on e-commerce platforms are able to buy the shots, colloquially known as “miracle drugs,” simply by declaring they have been diagnosed with diabetes—without providing proof.

They aren’t getting a bad deal: On JD.com, a monthly dosage of Ozempic retails for around $139. That is higher than its cost on the country’s national-insurance plan but much cheaper than the $970 some users pay in the U.S. each month. JD.com didn’t respond to requests for comment.

The gray market for Ozempic highlights a conundrum facing China’s government—how to tackle the world’s biggest obesity problem.

There are about 200 million obese adults in China, and an additional 400 million who are overweight, according to estimates by Jefferies based on official data. China will have another 100 million people with obesity in just over a decade, the investment banking firm predicts, despite the country’s declining population.

The demand for Ozempic is being driven by people who are willing to pay out of their own pockets rather than through health-insurance plans, said Christopher Lui, head of Asia healthcare research at Jefferies. “When the drugs get approved for weight loss, I think there will be a surge in demand,” he said.

In 2017, China’s health commission started a campaign it named the “three reductions and three healthy conditions,” calling for Chinese citizens to reduce their intake of salt, oil and sugar and strive for healthy oral hygiene, body weight and bones. The commission, with other government departments, also adopted a plan to fight obesity among children and adolescents. China’s share of children with obesity is above the world average, according to the World Health Organization.

Obesity isn’t a new problem for the country. China’s living standard improved after its entry into the World Trade Organization in 2001, contributing to an increase in intake of high-energy food among its population, said Zhuo Chen, a health policy and management professor at the University of Georgia.

In 2014, generals complained that Chinese soldiers were becoming too big to comfortably fit into tanks. But innovations in weight-loss drugs have shifted likely solutions away from personal discipline and toward corporate strategy.

Chinese companies are conducting late-stage trials for more than 10 varieties of a drug known as GLP-1 for use in obesity, according to pharmaceutical data provider PharmCube. The drug mimics a gut hormone that helps regulate blood-sugar levels and suppresses appetite.

The market for GLP-1 drugs in China was worth about $1.7 billion in 2023, although more than 80% of that came from diabetes prescriptions, according to market-research firm Clarivate. That market could grow fivefold in the next 10 years, boosted by the rise in the drugs’ use for weight loss, said Karan Verma, a healthcare research and data analyst at Clarivate who has looked into the China market.

Innovent Biologics, a Suzhou-based drugmaker listed in Hong Kong, in January said its first Phase 3 clinical trial of mazdutide—a GLP-1 drug for which the company has a license agreement with Eli Lilly—had met endpoints. China’s National Medical Products Administration has accepted Innovent’s application for the drug’s use in chronic weight management, the company said. Analysts predict the drug could come to market in China around early 2025.

Some companies are also tapping capital markets to raise funds for their obesity-drug development. Hangzhou Jiuyuan Gene Engineering, a drugmaker that filed for a Hong Kong initial public offering in January, is aiming to raise about $100 million in its listing, people familiar with the matter said.

Analysts and investors say the competition will be fierce, especially as Novo Nordisk’s patent for its semaglutide—the drug sold under brands Ozempic and Wegovy—is set to expire in 2026 in China, paving the way for generic drug production.

“I’m expecting significant competition in the Chinese market,” said Cyrus Ng, head of Asia healthcare equity research at Deutsche Bank. “The large number of products available in the market may result in a price war.”

Neither Wegovy—Ozempic’s sister drug specifically made for weight management—nor Mounjaro, another drug initially developed to treat Type 2 diabetes, has been approved for weight loss in China. Two locally made GLP-1 injections in the same drug category have been approved for treating obesity.

The current crop of drugs in China has a lot of room for improvement, analysts say. A drug sold by Huadong Medicine, one of the two companies that first got China’s approval to sell GLP-1 drugs for weight loss, requires a daily injection. Ozempic is typically taken once a week.

The competition to develop weight-loss drugs in China—and the demand for weight-loss drugs on the gray market—means how Beijing regulates the market in the years to come is an open question.

“There could be more regulation or clampdown on cosmetic uses,” said Wilfred Yuen, a China healthcare analyst at Daiwa Capital Markets. But regulatory action on the gray market still appears far out, given that supply for the drugs remains limited in the face of high demand, he added.

In October, the chairman of BrightGene Bio-Medical Technology, a Shanghai-listed pharmaceutical company, touted to participants of a conference call that he had tried the company’s weight-loss drug. He soon received a warning letter from China’s securities regulator, who said he was misleading investors about the efficacy of a drug that was still in development.

Novo Nordisk, which developed Ozempic, said the drug should only be used with a prescription. “We strongly urge patients to follow doctor’s prescription and guidance for drug use and get the medicine through regulated, approved channels to ensure drug effectiveness and safety,” it said.

Write to Dave Sebastian at dave.sebastian@wsj.com

Corrections & Amplifications
On JD.com, an Ozempic pen with a monthly dosage retails for around $139. An earlier version of this article incorrectly said an Ozempic shot retailed for around $139. A pen contains multiple injections. (Corrected on Feb. 19)
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