Reporter | Deng Lingyao
Editor | Yang Cheng
The Red Star Capital Bureau learned from the 2022 financial report of the hypoglycemic drug giant Novo Nordisk (NVO.US) that its hypoglycemic and weight-loss drug smeglutide subcutaneous injection preparation Ozempic (trade name: Novotai) is in the domestic market. After the patent was judged invalid, an appeal has been filed to the Beijing Intellectual Property Office in order to regain patent protection.
Whether the patent protection of semaglutide is ultimately invalid still needs to wait for the outcome of the lawsuit.
On the other hand, semaglutide has been approved for marketing in China, and its indication is type 2 diabetes. The indication for weight loss has not yet been approved, but it has been snapped up as a "weight loss medicine" in China.
There has even been a phenomenon of e-commerce platforms issuing a large number of fake prescriptions and selling scalpers at high prices.
Hypoglycemic drug giants caught in patent disputes
2 billion domestic market share was "cut off"
Novo Nordisk, the hypoglycemic drug giant, may break the monopoly of the domestic semaglutide market.
In early February, Novo Nordisk mentioned in its 2022 financial report that the company's major single product, Novota, had its patents subject to invalidation lawsuits in China.
According to public information, semaglutide, as the exclusive product of Novo Nordisk, was approved for marketing in the United States in 2017 for adults with type 2 diabetes, and was approved for weight loss indications in June 2021.
In April 2021, semaglutide was approved for marketing in China, and the indication is type 2 diabetes, which does not include weight loss.
Since semaglutide is a new type of hypoglycemic drug - GLP-1 receptor agonist, it is very popular.
The latest data from Novo Nordisk's 2022 financial report shows that the GLP-1 business revenue based on semaglutide reached 83.371 billion Danish kroner (about 82 billion yuan), accounting for nearly half of Novo Nordisk's 2022 full year income.
Among them, the sales of semaglutide in China alone have reached about 2 billion yuan.
In June 2021, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as "Zhongmei Huadong"), a wholly-owned subsidiary of Huadong Medicine (000963.SZ), filed a patent for Novo Nordismeglutide with the State Intellectual Property Office. Invalid declaration request.
In September 2022, all the above-mentioned patents were ruled invalid.
The patent protection period of the drug in China was originally scheduled to end in 2026.
Faced with this judgment, Novo Nordisk said it has filed an appeal to the Beijing Intellectual Property Office.
So far, the appeal has not been resolved.
In order to accelerate market share, Huadong Medicine has not only applied for invalid patents for original research drugs, but Huadong Medicine also has two semaglutide products under research.
Red Star Capital Bureau learned from the 2022 semi-annual report of Huadong Medicine that the semaglutide injection jointly developed by Zhongmei Huadong and Chongqing Paijin Biotechnology Co., Ltd. (hereinafter referred to as "Chongqing Paijin") was released in June 2022. Approved for clinical trials.
In February this year, Huadong Medicine disclosed on the investor interaction platform that the injection was in Phase 1 clinical stage.
Equity information shows that Zhongmei Huadong holds a 39.80% stake in Chongqing Paijin.
In addition, Huadong Medicine also stated that Jiuyuan Gene, another joint-stock company of Zhongmei Huadong, also applied for a self-developed semaglutide injection.
However, Huadong Medicine did not explain too much about this product.
Weight Loss Indications Are Overused
"Private chat" e-commerce customer service can issue fake prescriptions
After entering the domestic market, semaglutide has been abused more as a weight loss "miracle drug" than for type 2 diabetes indications.
Since semaglutide is a prescription drug, the prescription certificate needs to be uploaded when purchasing the drug on the e-commerce platform.
However, the Red Star Capital Bureau found that on multiple e-commerce platforms, in order to sell smoothly, the merchants did not strictly check, and even clearly marked the words "prescribing and contacting customers" on the cover of the medicine.
Even if consumers clearly inform merchants that they do not suffer from diabetes and use semaglutide as a weight-loss drug, many merchants still indicate that they can issue electronic prescriptions.
On February 24, after a platform e-commerce customer service sent a note on following offline doctor's orders for medication, they informed the Red Star Capital Bureau that a prescription for semaglutide could be issued by providing personal information such as an ID card.
On February 25, the customer service of an e-commerce platform asked Red Star Capital Bureau whether the purchase of semaglutide was for "lowering blood sugar or weight loss".
After getting the answer of "used for weight loss", the customer service immediately stated that electronic prescriptions can be issued.
When issuing electronic prescriptions, multiple stores showed that the indications for semaglutide included "obesity" and took precedence over diabetes.
In order to avoid platform supervision, some merchants even provide consumers with private contact numbers of pharmacists, saying that they can conduct "more professional consultation".
Public hospitals need to apply in advance
There are scalpers selling 70% more
Red Star Capital Bureau noticed that the market supply of semaglutide is relatively tight.
On February 25, a staff member of a public hospital pharmacy told the Red Star Capital Bureau, "We don't have this drug (semaglutide). You have to tell the doctor in advance that you need to use this drug. The doctor will apply for it and buy it back." Yes, there is no waiting."
In addition, the Red Star Capital Bureau found through offline visits that most pharmacies did not sell semaglutide, which exacerbated the shortage of semaglutide.
In addition, Novo Nordisk, the original drug manufacturer, also has a reminder on its official website: "Diabetes and hemophilia drugs are prescription drugs. Please bring your medical records or doctor's prescription when purchasing. Since the inventory changes quickly, it is recommended to call for confirmation before purchasing in the store. "
At the same time, scalpers are selling at high prices.
The Red Star Capital Bureau learned from the online drug bulletin board of a public hospital that semaglutide is currently divided into two dosage forms in China, 1.5ml or 3ml (both 1.34mg/ml), and the price is 478.8 yuan / bottle respectively and 813.96 yuan/piece.
However, some scalpers sell semaglutide at a high price to the Red Star Capital Bureau. Compared with public hospitals, the price of scalpers may be 70% higher.
Some cattle said that most people who buy semaglutide are for weight loss. The price of 1.5ml is 620 yuan, and the price of 3ml is 1100 yuan, and there is no quantity limit.
Regarding Red Star Capital Bureau's questioning of the authenticity of the drug, it stated that after the arrival of the product, the authenticity can be verified by scanning the code, including "Alipay scans the bar code" and "the public account 'Nuohe Care' scans the code to verify".
The scalper said that the semaglutide in his hand came from the hospital or Novo Nordisk, but he could not give the purchase certificate.
Another scalper also said that he purchased semaglutide through the hospital. The price of 1.5ml size is 740 yuan, and the price of 3ml size is 1380 yuan.
Faced with Red Star Capital Bureau's questioning about the authenticity of the hospital and purchasing agents, the scalper was very cautious, saying "don't bother".
So, what is the effect on the body of non-diabetic patients injecting semaglutide?
On February 24, Cao Bokepu, a medical consultant for innovative drugs, said, "Some people may use this drug in a large amount at the beginning, which may cause nausea and other adverse reactions, but there are no absolutely unbearable symptoms."
An endocrinologist from a tertiary hospital said that semaglutide has some contraindications, including: those who are allergic to the active ingredients of this product or any excipients in this product; personal or family medical history of medullary thyroid carcinoma (MTC) , or patients with multiple endocrine neoplasia syndrome type 2 (MEN2).
Therefore, even if people with normal blood sugar want to use semaglutide for weight loss, it is best to have a thyroid ultrasound.
On February 25, the staff of the offline pharmacy told the Red Star Capital Bureau that according to their knowledge, a large number of people in the market currently use semaglutide as a "weight loss drug", and according to their feedback, most of them have side effects such as not wanting to eat , "Don't hit (semaglutide) casually".