Nine Endocrine and Metabolic New Drugs Expected for Approval in China in H2 2025

According to the "China Market Entry Strategy & Timeline Prediction" module in the Insight database, more than 50 new drugs are expected to be launched in the second half of 2025.(Excluding modified new drugs and similar drugs)First approved for marketing in China, this article will share information on 9 new drugs in the endocrine and metabolism fields, for reference only.

Scan the QR code below to add the Insight Intelligence Assistant「Little Sound」, Reply CommandThe second half of the year, you can obtain the complete list of new drugs expected to be approved in China in the second half of the year, compiled by Insight.

Novo Nordisk: Pasireotide

In September 2024, Novo Nordisk's Pasireotide（Somapacitan）Injection solution submitted for marketing approval in China, speculated to be used for treatment.Growth Hormone Deficiency in Children, expected to be approved in Q4 this year.

Somapacitan is a long-acting human growth hormone protein derivative. Compared with the existing once-daily growth hormone, Somapacitan canReducing the number of annual treatments from 365 to 52, greatly enhancing the convenience and compliance of patient treatment. The drug has been approved in overseas countries and regions such as the United States, the European Union, and Japan for the treatment of children and adults.Growth Hormone Deficiency。

In China, Somapacitan was first introduced in April this year at the Boao Lecheng International Medical Tourism Pilot Zone in Hainan, for use inReplacement of endogenous growth hormone in children and adolescents aged 3 years and above with growth retardation caused by growth hormone deficiency。

Sanofi: Tislelizumab

In August 2024, Sanofi'sTilizumab InjectionSubmitted for marketing approval in China and included in the priority review for useTreatment of Type 1 Diabetes. The application is expected to be approved in Q4 this year.

Type 1 diabetes is a chronic autoimmune disease, in which insulin-producing pancreatic β-cells are destroyed by the autoimmune system, leading to insulin deficiency.Islet"Scarcity"Thereby affecting the body's ability to regulate blood sugar levels.

Tilizumab is a monoclonal antibody targeting CD3., which can protect pancreatic β-cells from the etiological perspective,Achieve a nearly 3-year delay in the onset of Type 1 diabetes。In November 2022, the drug received FDA approval for marketing and becameThe World's First Innovative Targeted Therapy to Delay the Onset of Type 1 Diabetes。

In China, Tildrakizumab has been included in the fourth batch of the list of children's medicines encouraged for research and development. In July 2024, the drug was introduced as a clinically urgently needed imported medicine and began to be used in advance in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan.

UCB/Amgen: Romosozumab

In July 2024, UCB filed in ChinaRomosozumabThe listing application is speculated to be forPostmenopausal OsteoporosisPatient treatment is expected to be approved in Q4 this year.

Romosozumab is a monoclonal antibody targeting sclerostin jointly developed by UCB and Amgen. Previously, the drug has been approved in Japan for the treatment of osteoporosis, and in the United States and the European Union for the treatment of postmenopausal osteoporosis. In 2024,RomosozumabGlobal sales reached $2.072 billion, representing a year-over-year increase of 69%.

In China, romosozumab has completed a randomized, double-blind, placebo-controlled Phase III study for the treatment of postmenopausal women with osteoporosis.

Hebei Changshan Biochemical Pharmaceutical Co., Ltd.: Exenatide

In April 2024, Hebei Changshan Biochemical Pharmaceutical Co., Ltd.'s Class 1 New DrugIbentide InjectionInReported for listing in China, used forTreatment of Type 2 Diabetes, expected to be approved for marketing in Q3 this year.

Exenatide isA Long-Acting GLP-1 Receptor Agonist, which utilizes drug affinity conjugates（DACTM）The technology chemically modifies exenatide and combines it with recombinant human serum albumin to form a completely new and stable compound. Exenatide has extended the drug's half-life and duration of efficacy in the body.Can achieve the effect of once-weekly dosing.。

Previously, in two Phase III clinical trials conducted among Chinese subjects with type 2 diabetes, Ebinatide achieved the primary endpoint and key secondary endpoints. Clinical data showed:

• Continuous administration for 24 weeks, Ibeneptide significantly reduced the blood glucose levels of the subjects, with a relatively fast onset of action. Significant efficacy was observed by the 5th week, and blood glucose levels continued to decrease from the 5th to the 17th week of treatment, stabilizing by the 17th week. The efficacy was maintained up to 52 weeks.

• At the same time, Ebinatide has demonstrated good safety and tolerability, with no occurrences of death or pancreatitis events, and no new unexpected safety risks have emerged.

VISEN: Long-acting Growth Hormone

In March 2024, VISEN PharmaceuticalsLong-acting Growth HormoneApplication for marketing authorization in China, intended for the treatment ofGrowth Hormone Deficiency in Children, expected to be approved for marketing in Q4 this year.

Long-acting growth hormone is a product developed by Ascendis.Once-weekly long-acting growth hormone replacement therapy, which can continuously release unmodified human growth hormone in the body. In November 2018, VISEN Pharmaceuticals acquired the development and commercialization rights for this product in China from Ascendis.

VISEN's key Phase III clinical trial data for long-acting growth hormone treatment of PGHD completed in China shows that52-Week Annualized Growth Rate（AHV）10.66 cm/year, higher than the daily injection of short-acting human growth hormone(9.75 cm/year)At the same time, long-acting growth hormone has good safety and tolerability.

Dongyang Sunshine Pharmaceutical: Ologliptin

January 2024, Dongyang Light Pharmaceutical Class 1 New DrugOlogliptin(Former name: Pyroglutamic Acid Rongge Net)Application for domestic market approval, used forType 2 DiabetesThe treatment is expected to be approved in Q4 this year.

Ologliflozin is an investigational SGLT-2 inhibitor that has demonstrated comprehensive and sustained glucose-lowering effects in two Phase III clinical trials. Data shows:

• After 24 weeks of treatment, compared with placebo,Ologlitazon Monotherapy 50 mg, 20 mg Groups Showed Primary Efficacy Endpoint HbA1c Reductions of 1.01%, 0.94% Respectively. Statistically significant 2-hour postprandial blood glucose data(Mainly Chinese patient data)Compared with other SGLT-2 inhibitor data, ologliptin shows a greater reduction in fasting blood glucose and 2-hour postprandial blood glucose.

• At the same time, ologliptin has good safety, with fewer gastrointestinal side effects, a lower rate of urinary tract infections compared to the placebo group, and no adverse reactions related to insufficient blood volume.

Newsoara BioPharma Co., Ltd.: Bexagliflozin

In January 2024, Newsoara BioPharma Co., Ltd. submitted Beglitin.(THR1442 Tablets)The listing application is speculated to be forType 2 DiabetesThe treatment is expected to be approved in Q4 this year.

Begelnet（Bexagliflozin）It is an SGLT-2 inhibitor developed by TheracosBio, and Newsoara BioPharma Co., Ltd. holds the development rights for the China region. In February 2023, Bexagliflozin was approved for marketing in the United States as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

In China, Newsoara BioPharma Co., Ltd. has completed a Phase III clinical study that was randomized, double-blind, and positive-controlled.（CTR20210322）The trial aims to compare in patients with type 2 diabetes who have inadequate blood glucose control after metformin monotherapy.Metformin Combined with BexagliflozinOrDapagliflozinEfficacy and Safety. Data show that metformin + begliflozin and metformin + dapagliflozin groups have similar efficacy and safety.

PegBio: Vipadore

In September 2023, PegBio's Class 1 new drugVISEN Pharmaceuticals (Shanghai) Co., Ltd.Reported for listing in China, intended for improving adult conditionsType 2 DiabetesThe patient's blood glucose control is expected to be approved in Q4 this year.

VISEN Pharmaceuticals (Shanghai) Co., Ltd.'s Vipanatide Injection is aLong-acting GLP-1 Receptor Agonist. The drug is pegylated（PEG）Technological modification can retain the high bioactivity of the GLP-1 polypeptide while achieving the goal of low-dose high efficacy.

The phase III clinical study of Vipenatide Injection for the treatment of Chinese patients with type 2 diabetes has been completed. The two pivotal phase III clinical trials of Vipenatide were both multicenter, randomized, double-blind, placebo-controlled, respectively evaluatingVipeglutide Monotherapy and Combination with MetforminEfficacy and Safety in Treating Type 2 Diabetes Patients. Data from two Phase III clinical trials showed that treatment with Vipenatide either as monotherapy or in combination with metformin demonstrated significant efficacy for type 2 diabetes, along with good tolerability and safety.

Baoling Fojin Biotech/WEGO Group: Ferric Citrate

In August 2023, Bao Ling Fu Jin Biotech and WEGO Group jointly submittedFerric Citrate CapsulesThe marketing application for the treatment ofHyperphosphatemia in Dialysis Patients, expected to be approved in Q4 this year.

Ferric Citrate Capsules are an oral chemical drug initially developed by Akebia. This novel therapy provides an effective source of trivalent iron, addressing iron deficiency and playing a key role in controlling phosphate absorption.

Ferric Citrate Capsules have been approved for marketing in the United States, Japan, South Korea, Thailand, and other regions for the treatment of iron deficiency anemia, hyperphosphatemia in chronic kidney disease, and hyperphosphatemia. In April this year, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) It is also recommended to approve the drug for the treatment of chronic kidney disease. (CKD)。

In China, the ferric citrate capsule has completed a pivotal Phase III clinical trial.（CTR20191035）The study aims to evaluate the efficacy and safety of ferric citrate capsules in controlling hyperphosphatemia in dialysis patients with chronic kidney disease.

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