The first domestic hormone replacement therapy for the treatment of hypoparathyroidism was approved for Phase III clinical press release

—VISEN Pharmaceuticals obtained the China Phase III clinical trial (PaTHway China trial) for TransCon PTH injection (ie TransCon™ parathyroid hormone) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) Approval
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—The PaTHway China trial aims to evaluate the possibility of TransCon™ parathyroid hormone as a hormone replacement therapy.
The goal is to bring the subjects' blood calcium to normal while discontinuing conventional treatments
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—TransCon™ parathyroid hormone is injected once a day.
The administration design can realize the continuous exposure of PTH within the normal physiological concentration range, that is, simulate the continuous infusion of PTH, which is expected to provide a truly ideal hormone replacement therapy for HP patients
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Every year, June 1st is World Hypoparathyroidism Day
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VISEN Pharmaceuticals, a new biomedicine that focuses on the development and commercialization of innovative drugs in the endocrine field, issued an announcement, announcing that it was awarded the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) about TransCon on June 1.
™ Parathyroid hormone China Phase III clinical trial (PaTHway China trial) approval, and the TransCon™ Parathyroid hormone treatment study of HP will be launched in China soon
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Hypoparathyroidism (HP) is a group of clinical syndromes caused by undersecretion and/or insufficient effect of parathyroid hormone (PTH)
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The clinical features are hypocalcemia, hyperphosphatemia and the resulting increase in neuromuscular excitability and ectopic calcification of soft tissues
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1 The prevalence of different countries and regions is different.
It is estimated that the prevalence of HP in the United States is about 37 per 100,000
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TransCon PTH has been defined as an orphan drug category by the FDA and the European Union
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The 2PaTHway China trial is designed to evaluate the possibility of TransCon™ parathyroid hormone as a hormone replacement therapy.
The primary endpoint includes evaluating the safety, tolerability and efficacy of once daily subcutaneous injection of TransCon™ parathyroid hormone in the treatment of adult HP The randomized, double-blind, placebo-controlled, parallel-designed, multi-center Phase III clinical trial aimed at bringing the subjects’ blood calcium to normal while discontinuing conventional treatments
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The key secondary efficacy endpoints of PaTHway China include the evaluation of patients receiving TransCon™ parathyroid hormone, the changes in the scores of the "Hypoparathyroidism Patient Experience Scale (HPES)" and the "36-item Health Survey Summary"
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In addition, there is still a lack of patient report data on the quality of life of HP patients, employment status, and the impact of the disease on work in China.
The PaTHway China trial will also obtain further patient report data in the form of a scale to assess changes in the survival status of patients before and after treatment
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Dr.
Yang Jun, Chief Medical Officer of Weisheng Pharmaceutical, said that hormone replacement has always been the basic treatment principle for endocrine gland dysfunction
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However, hypoparathyroidism has not yet achieved true hormone replacement to correct related pathophysiological changes and metabolic disorders
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3 TransCon™ parathyroid hormone is an innovative long-acting PTH under development.
It is planned to be developed as a hormone replacement therapy for adult HP injected subcutaneously once a day.
It aims to provide normal physiological concentration of PTH 24 hours a day to cope with it at the same time.
Short-term symptoms and long-term complications of HP
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"The China Phase III clinical trial approval was obtained on the World Hypoparathyroidism Day, which greatly encouraged the team's morale and encouraged us to continue to work hard to accelerate the development of innovative drugs and solve unmet clinical needs!" TransCon™ Parathyroid hormone Phase II clinical study (PaTH Forward study) data has demonstrated the potential of TransCon™ Parathyroid hormone as a replacement therapy for HP
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The 58-week preliminary study results of the open expansion phase of PaTH Forward released recently also continue to support the safety characteristics of TransCon™ parathyroid hormone in the treatment of HP with long-lasting benefits and well-tolerated safety
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Weisheng Pharmaceutical is responsible for the development and promotion of Ascendis Pharma's endocrine therapy solutions in Greater China
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Mr.
Lu Anbang, CEO of Weisheng Pharmaceuticals, said: “More than 200,000 patients worldwide suffer from HP.
HP can cause severe short-term symptoms and long-term complications, which will seriously affect the quality of life of patients.
The current conventional treatments are difficult to meet the clinical needs of patients.
Demand, as the exclusive authorized R&D and sales company of TransCon™ parathyroid hormone in Greater China, Weisheng Pharmaceutical will carry out relevant clinical trials in China, hoping to bring new treatment options to Chinese HP patients as soon as possible
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"About PaTHway China A phase III, multi-center, randomized, double-blind, placebo-controlled, multi-center, randomized, double-blind, placebo-controlled trial aimed at studying the safety, tolerability and efficacy of once daily subcutaneous injection of TransCon PTH in adult subjects with hypoparathyroidism The parallel group trial (including the open expansion phase) lasts for 26 weeks and has a 3-year open expansion phase study
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The test is for the diagnosis of postoperative chronic HP or autoimmune, hereditary or idiopathic HP for at least 26 weeks, and has received calcitriol ≥0.
5 μg/day or alfacalcidol ≥1.
0 μg/day before screening, and Adult male and female subjects treated with elemental calcium ≥800 mg/day for at least 12 weeks receive daily treatment with TransCon PTH or placebo
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About hypoparathyroidism (HP) HP is a rare endocrine deficiency disease characterized by undersecretion of PTH and/or insufficient effect, leading to decreased blood calcium and increased blood phosphorus
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In the United States, Europe, Japan, and South Korea, HP affects approximately 200,000 patients, most of which are caused by parathyroid gland damage or accidental removal during thyroid surgery
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Short-term symptoms include weakness, severe muscle cramps (hand and foot twitches), abnormal sensations such as tingling, burning and numbness (paresthesia), memory loss, decreased judgment, and headaches
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Long-term will increase the risk of major complications, such as extra-skeletal calcium deposits in the brain, eye lens and kidneys (which can lead to impaired renal function), and at the same time lead to a decline in the patient's quality of life
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So far, HP is still one of the few hormone deficiency diseases that cannot be treated by supplementing the missing hormones
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Conventional treatments supplemented with active vitamin D analogs and calcium can not completely control the disease and may lead to the risk of kidney disease
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In fact, compared with healthy controls, HP patients have a 4-8 times risk of developing kidney disease
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About VISEN Pharmaceuticals, VISEN Pharmaceuticals is committed to becoming an expert in the field of endocrine-related treatments, introducing the world’s leading treatment methods and drugs into China, hoping to allow more Chinese patients to benefit from the world’s advanced and reliable Treatment plan
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Weisheng Pharmaceutical was established in 2018 by a joint investor led by Ascendis Pharma A/S (Nasdaq: ASND) and Vivo Capital.
Sofinnova Ventures participated in the first round of investment
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In January 2021, Weisheng Pharmaceutical completed the Series B financing led by Sequoia China Fund, Aobo Capital, Sherpa Investment, Cormorant, HBM Healthcare Investments, Dingfeng Biotech Capital, Logos Capital, and Chenling Capital.

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Weisheng Pharmaceutical has obtained the exclusive authorization of Ascendis to develop and promote its endocrine treatment solutions in Greater China, and the authorization covers mainland China, Hong Kong, Macao and Taiwan
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Reference sources: 1.
Osteoporosis and Bone Mineral Diseases Branch of Chinese Medical Association, Metabolic Osteopathy Group of Endocrine Branch of Chinese Medical Association.
Guidelines for Clinical Diagnosis and Treatment of Hypoparathyroidism.
Chinese Journal of Osteoporosis and Bone Mineral Diseases .
2018; 11(4): 323-3382.
Ascendis Pharma Announces Orphan Drug Designation Granted for TransCon PTH as Treatment for Hypoparathyroidism Retrieved Jun 1,2021, from https://ascendispharma.
gcs-web.
com/news-releases/news -release-details/ascendis-pharma-announces-orphan-drug-designation-granted-0?ID=2353621&c=242088&p=irol-newsArticle3.
Chinese Medical Association Osteoporosis and Bone Mineral Disease Branch, Chinese Medical Association Endocrine Branch Metabolism Osteopathy Group.
Guidelines for clinical diagnosis and treatment of hypoparathyroidism.
Chinese Journal of Osteoporosis and Bone Mineral Diseases.
2018; 11(4): 323-338