21 Health Daily | China Issues First Filing Certificates for Protein Powder Health Supplements; Amgen's Osteoporosis Drug Prolia Receives FDA Black Box Warning

Source: 21st Century Economic Report

●Health Food Protein Powder Receives First Filing Certificate

According to a report by Xinhua News Agency on the 22nd, the first filing certificate for protein powder as a health food supplement and the first filing certificate for compounded protein powder products were recently issued, as disclosed by the Food Review Center of the State Administration for Market Regulation. These are the first filing certificates for domestically produced health food supplements using isolated soy protein and whey protein as ingredients since the publication of the raw material directory for health foods by the State Administration for Market Regulation in June 2023.

This time, both plant protein and animal protein have been included in the raw material directory for health food products, primarily targeting populations with protein deficiency and low immunity. This enhances the targeted use of health food products among specific groups and restricts exaggerated claims about the products. While strictly adhering to the bottom line of food safety, the protein content standards have been increased to ensure high-quality protein products are provided to those with protein deficiencies.

According to reports, in order to promote the standardized development of the health food industry, the "Health Food Raw Material Directory: Soy Protein Isolate" and the "Health Food Raw Material Directory: Whey Protein," released by the State Administration for Market Regulation in collaboration with relevant departments, have been implemented since October 2023. This means that protein powder health foods containing soy protein isolate and whey protein can now access a new pathway to market through registration, breaking the previous model of single-ingredient registration. The new regulations allow protein powder to be registered in combination with nutrients, providing consumers with a wider variety of protein powder health foods at higher cost-effectiveness.

● Eisai's Gout Treatment Drug Dotinurad Submitted for Marketing Approval in China

On January 20, according to the announcement on the CDE official website, the marketing application for Dotinurad Tablets submitted by Eisai under Registration Category 5.1 has been accepted. Dotinurad Tablets (Dotinurad, trade name: Uloric) is a uricosuric agent that was previously launched in Japan in 2020 for the treatment of hyperuricemia and gout.

Dotinurad is a novel gout treatment drug that selectively inhibits urate transporter 1 (URAT1), which is associated with uric acid reabsorption in the kidneys, thereby suppressing uric acid reabsorption and reducing serum uric acid levels. As a selective URAT1 inhibitor, dotinurad effectively inhibits URAT1 in the proximal renal tubules without affecting the function of uric acid excretion factors ABCG2 and OAT1/3, showing higher efficiency in lowering serum uric acid compared to non-selective URAT1 inhibitors.

● First! Johnson & Johnson's Bladder Cancer Targeted Small Molecule Receives Full FDA Approval

Recently, Johnson & Johnson announced that its small molecule inhibitor Balversa (erdafitinib) has received full approval from the U.S. FDA for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) who have FGFR3 genetic alterations and whose disease has progressed after at least one prior line of systemic therapy.

According to the introduction, Balversa is the first approved oral fibroblast growth factor receptor (FGFR) kinase inhibitor and also the first targeted drug for treating patients with FGFR-altered mUC.

● New Horizon Health Releases 2023 Annual Report Preview: Total Annual Revenue Exceeds 2 Billion Yuan

On January 22, after the close of the Hong Kong Stock Exchange, New Horizon Health released its 2023 annual report preview. According to unaudited financial data medians, as of December 31, 2023, the group's total annual revenue reached RMB 2.01 billion, representing a 164% increase compared to 2022. Cash receipts exceeded RMB 1.4 billion, and the company achieved an annual gross profit of RMB 1.84 billion, realizing its first post-tax profit. In 2023, New Horizon Health's flagship product, Changwei Qing, contributed 59% to the group’s total revenue, with over 1.04 million samples tested and confirmed revenue reaching RMB 1.19 billion, marking a 235% increase in confirmed revenue compared to 2022.

● Everest Medicines: 2023 revenue increase approaches 10 times

On January 22, Hong Kong-listed pharmaceutical company Everest Medicines announced that based on preliminary unaudited calculations, the company expects its total revenue for 2023 to reach RMB 124 million to 126 million, with revenue growth nearing 10 times.

This forecast represents a significant increase compared to the RMB 128 million revenue in 2022, primarily driven by the successful commercial launch of the innovative and potent antibacterial drug Ekspla® in China in July 2023 and the global first-in-class IgA nephropathy treatment Nefuxin® in Macao, China, in December 2023.

This projected revenue is also significantly higher than the company's previous guidance of RMB 70 million to RMB 100 million, highlighting that Eeja® meets the urgent clinical need for treating infections caused by multidrug-resistant organisms, especially carbapenem-resistant Gram-negative bacteria (CRO) and critically ill patients with atypical pathogen infections, including drug-resistant mycoplasma.

●Sansure Biotech: Estimated 2023 Net Profit to Decrease by 80% to 82%

On the 22nd, Saintway Biotech announced that the estimated net profit attributable to shareholders for 2023 will be RMB 356 million to RMB 381 million, a year-on-year decrease of 80% to 82%. During the reporting period, the company's operating income and net profit decreased, mainly due to changes in public health prevention and control policies both domestically and internationally, leading to a sharp decline in demand for COVID-19 nucleic acid testing reagents and instruments, resulting in a decrease in related business revenue. In the first three quarters of 2023, the company achieved operating revenue of RMB 633 million, and it is expected that the operating revenue for the fourth quarter of 2023 will be RMB 367 million to RMB 387 million, with a quarter-on-quarter increase of 79% to 89%. In 2023, the company has made breakthrough developments in multiple fields such as respiratory, HPV, blood screening, and sequencing, achieving several times growth compared to the same period last year.

● Amgen's osteoporosis drug Prolia, already launched in China, receives FDA black box warning

On January 19, the FDA announced that a black box warning would be added to Amgen's osteoporosis drug Prolia (denosumab). Prolia can pose a serious risk of hypocalcemia in patients with advanced chronic kidney disease (CKD), especially those on dialysis. Severe hypocalcemia can lead to significant harm, including hospitalization, life-threatening events, and death.

Black Box Warning is the strictest warning issued by the U.S. FDA regarding the potential serious side effects of using a drug.

Prolia was first approved by the FDA in 2010 for the treatment of postmenopausal women with osteoporosis at high risk of fractures, and later also approved for use in men and women at high risk of fractures. The product has now been approved for marketing in more than 80 countries and regions worldwide. Sales in the first three quarters of 2023 reached $4.614 billion.

In China, in February last year, Prolia was approved by the NMPA for the treatment of male osteoporosis with a high risk of fractures. It is currently the first and only anti-RANKL monoclonal antibody drug in China for treating male osteoporosis. Previously, Prolia had been approved for female indications, which were included in the National Medical Insurance Drug List of China through negotiations in 2020.