Precocious puberty

GenSci Launches Global Innovation Hub in Shanghai

Retrieved on: 
Saturday, December 23, 2023

SHANGHAI, Dec. 22, 2023 /PRNewswire/ -- Changchun GeneScience Pharmaceutical ("GenSci"), a subsidiary of Changchun High-Tech Industries (Group), held a groundbreaking ceremony for its new global headquarters and research & development (R&D) center at Shanghai Zhangjiang International Medical Park on December 15th. With an increasing focus on women`s and children`s health, the Chinese government has been intensifying efforts to improve healthcare services for these demographics, embedding their care within the wider framework of the country's economic and social development policies. The establishment of the R&D center sets the stage for GenSci to further advance the convergence of industry, academia, research and the medical community. By leveraging cutting-edge R&D capabilities and the application of artificial intelligence technologies, GenSci is well-positioned to provide premium health solutions for women and children. The initiative aligns with GenSci's commitment to harnessing science and technology to protect and enhance the health of these vulnerable groups.

Key Points: 
  • SHANGHAI, Dec. 22, 2023 /PRNewswire/ -- Changchun GeneScience Pharmaceutical ("GenSci"), a subsidiary of Changchun High-Tech Industries (Group), held a groundbreaking ceremony for its new global headquarters and research & development (R&D) center at Shanghai Zhangjiang International Medical Park on December 15th.
  • Integrating AI technology, GenSci covers the entire drug innovation process, from initial design and screening to process development and formulation.
  • GenSci has formed enduring and robust partnerships with nearly 20 prominent universities, including Shanghai Jiao Tong University and Zhejiang University.
  • The groundbreaking of GenSci's global innovation hub and R&D center enpowers the company to fully utilize its expertise in gynecology and pediatrics.

Peptron's PT105, a sustained-release Leuprolide, established the bioequivalence with Takeda's Leuplin

Retrieved on: 
Monday, November 28, 2022

Peptron's PT105, a sustained-release Leuprolide, established the bioequivalence with Takeda's Leuplin.

Key Points: 
  • Peptron's PT105, a sustained-release Leuprolide, established the bioequivalence with Takeda's Leuplin.
  • PT105 represents Korea's first commercialized generic drug of Leuplin, applied with SmartDepot technology.
  • "Compared to Takeda's Leuplin, PT105 has reduced particle size and smaller needle gauge, which will improve patients' convenience," said an official of Peptron.
  • "After the launch of PT105 in the domestic market, we will enter the global market with potential partners based on established bioequivalence and international standards."

Peptron's PT105, a sustained-release Leuprolide, established the bioequivalence with Takeda's Leuplin

Retrieved on: 
Monday, November 28, 2022

Peptron's PT105, a sustained-release Leuprolide, established the bioequivalence with Takeda's Leuplin.

Key Points: 
  • Peptron's PT105, a sustained-release Leuprolide, established the bioequivalence with Takeda's Leuplin.
  • PT105 represents Korea's first commercialized generic drug of Leuplin, applied with SmartDepot technology.
  • "Compared to Takeda's Leuplin, PT105 has reduced particle size and smaller needle gauge, which will improve patients' convenience," said an official of Peptron.
  • "After the launch of PT105 in the domestic market, we will enter the global market with potential partners based on established bioequivalence and international standards."

China Leuprorelin Market Investigation Report 2021: Sales 2016-2020, Major Manufacturers, Prices 2020-2021, Prospects 2021-2025 - ResearchAndMarkets.com

Retrieved on: 
Thursday, March 10, 2022

The "Investigation Report on China's Leuprorelin Market 2021-2025" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Investigation Report on China's Leuprorelin Market 2021-2025" report has been added to ResearchAndMarkets.com's offering.
  • According to the market research, the sales value of Leuprorelin in the Chinese market increased rapidly year by year from 2016 to 2019.
  • The sales value of Leuprorelin in the Chinese market reached CNY1108 million in 2020 and the CAGR was 15.1% in 2016 to 2020.
  • 2 Sales of Leuprorelin in China, 2016-2020
    2.3 Sales of Leuprorelin by Dosage Form in China, 2016-2020
    3.2.2 Sales of ENANTONE (Takeda Pharmaceutical Co., Ltd.'s Leuprorelin) in China
    3.3 Shanghai Livzon Pharmaceutical Co., Ltd.
    3.3.2 Sales of Beiyi (Shanghai Livzon Pharmaceutical Co., Ltd.'s Leuprorelin) in China
    3.4 Beijing Biote Pharmaceutical Co., Ltd.
    3.4.2 Sales of Boennuokang (Beijing Biote Pharmaceutical Co., Ltd.'s Leuprorelin) in China
    4 Prices of Leuprorelin for Different Manufacturers in China, 2020-2021
    4.2 Shanghai Livzon Pharmaceutical Co., Ltd. (Beiyi)
    4.3 Beijing Biote Pharmaceutical Co., Ltd. (Boennuokang)
    5 Prospect of Chinese Leuprorelin Market, 2021-2025
    View source version on businesswire.com: https://www.businesswire.com/news/home/20220310005676/en/

Willenken Wins Critical Liability Phase of High-Profile Lupron Supply Shortage Trial in Delaware Chancery Court

Retrieved on: 
Monday, September 27, 2021

After an FDA inspection in November 2019 found serious quality deficiencies at one of Takeda's Japanese Lupron manufacturing facilities, production and supply disruptions caused a world-wide Lupron supply shortage.

Key Points: 
  • After an FDA inspection in November 2019 found serious quality deficiencies at one of Takeda's Japanese Lupron manufacturing facilities, production and supply disruptions caused a world-wide Lupron supply shortage.
  • Takeda then allocated the scarce Lupron supply in favor of its own markets and to the grave detriment of AbbVie's exclusive U.S. and Canadian markets.
  • Led by partner Paul Loh , the 100-percent-diverse Willenken trial team filed suit in Delaware Chancery Court in late 2020.
  • Click here for the September 22, 2021 Delaware Chancery Court decision in this case.

Tolmar Launches "Little a Little Longer" Campaign A Caregiver's Guide to Central Precocious Puberty

Retrieved on: 
Friday, February 19, 2021

BUFFALO GROVE, Ill., Feb. 19, 2021 /PRNewswire/ -- Tolmar Pharmaceuticals, Inc., a specialty pharmaceutical company, today announced their launch of "Little a Little Longer," a newly established community and guide for caregivers who have children with Central Precocious Puberty (CPP).

Key Points: 
  • BUFFALO GROVE, Ill., Feb. 19, 2021 /PRNewswire/ -- Tolmar Pharmaceuticals, Inc., a specialty pharmaceutical company, today announced their launch of "Little a Little Longer," a newly established community and guide for caregivers who have children with Central Precocious Puberty (CPP).
  • Little a Little Longerwill feature content for parents no matter where their child is in the disease.
  • Little a Little Longer will also help teach parents everything they need to know about the effects of CPP.
  • New topics and interactive contents will appear each month, ensuring that the Little a Little Longer community remains continuously educated on and connected to CPP.

Growth Hormone, Estrogen Exposure Combine to Trigger Early Puberty, Raise Risk of Breast Cancer

Retrieved on: 
Tuesday, September 1, 2020

Essentially, girls who enter puberty early in lifeas measured by early breast development and age of first menstrual periodhave a longer window of susceptibility to breast cancer.

Key Points: 
  • Essentially, girls who enter puberty early in lifeas measured by early breast development and age of first menstrual periodhave a longer window of susceptibility to breast cancer.
  • A number of studies have established a link between early puberty and breast cancer risk," Biro says.
  • A greater ratio of estrone to androstenedione leads to greater overall exposure to estrogen, another risk factor for breast cancer.
  • These findings suggest that girls experiencing early puberty can take steps throughout their lives to reduce their breast cancer risk.

Arbor Pharmaceuticals, LLC Confirms Availability of Triptodur® (triptorelin) for Patients with Central Precocious Puberty

Retrieved on: 
Tuesday, August 25, 2020

"We can assure healthcare professionals and patients in the U.S. that we have a stable supply of Triptodur and do not anticipate any delays or shortages."

Key Points: 
  • "We can assure healthcare professionals and patients in the U.S. that we have a stable supply of Triptodur and do not anticipate any delays or shortages."
  • Arbor Pharmaceuticals is committed to helping patients with CPP maintain their prescribed injection schedule.
  • The Triptodur Care Program is available to help healthcare professionals and families of CPP patients receive the access and guidance they need.
  • Efficacy and safety of triptorelin 6-month formulation in patients with central precocious puberty.

FDA Approves FENSOLVI® (leuprolide acetate) for Injectable Suspension for Pediatric Patients with Central Precocious Puberty

Retrieved on: 
Monday, May 4, 2020

FDA approval was based on results from a multicenter, open-label, single arm Phase 3 study evaluating the efficacy, safety and pharmacokinetics of leuprolide acetate (LA) 45 mg for injectable suspension in 64 children with central (gonadotropin-dependent) precocious puberty.

Key Points: 
  • FDA approval was based on results from a multicenter, open-label, single arm Phase 3 study evaluating the efficacy, safety and pharmacokinetics of leuprolide acetate (LA) 45 mg for injectable suspension in 64 children with central (gonadotropin-dependent) precocious puberty.
  • The study also demonstrated that Fensolvi suppressed sex hormones to pre-pubertal levels, and stopped or reversed the progression of clinical signs of puberty.
  • Fensolvi (leuprolide acetate) for injectable suspension is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients two yearsof age and older with CPP.
  • FENSOLVI (leuprolide acetate) for injectable suspension is a gonadotropin releasing hormone (GnRH) agonist used to treat patients 2 years of age and older with central precocious puberty (CPP).

FDA Approves FENSOLVI® (leuprolide acetate) for Injectable Suspension for Pediatric Patients with Central Precocious Puberty

Retrieved on: 
Monday, May 4, 2020

FDA approval was based on results from a multicenter, open-label, single arm Phase 3 study evaluating the efficacy, safety and pharmacokinetics of leuprolide acetate (LA) 45 mg for injectable suspension in 64 children with central (gonadotropin-dependent) precocious puberty.

Key Points: 
  • FDA approval was based on results from a multicenter, open-label, single arm Phase 3 study evaluating the efficacy, safety and pharmacokinetics of leuprolide acetate (LA) 45 mg for injectable suspension in 64 children with central (gonadotropin-dependent) precocious puberty.
  • The study also demonstrated that Fensolvi suppressed sex hormones to pre-pubertal levels, and stopped or reversed the progression of clinical signs of puberty.
  • Fensolvi (leuprolide acetate) for injectable suspension is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients two yearsof age and older with CPP.
  • FENSOLVI (leuprolide acetate) for injectable suspension is a gonadotropin releasing hormone (GnRH) agonist used to treat patients 2 years of age and older with central precocious puberty (CPP).