Daewoong Pharmaceutical

CGBio's 'NOVOSIS PUTTY' Receives FDA 'Breakthrough Device Designation,' Accelerate Entry into the US Market

Retrieved on: 
Tuesday, January 2, 2024
BDD, Food, Agency, Risk, FDA, WHO, Health, Bone morphogenetic protein 2, Clinical trial, USD, Public, Device, Patient, Diagnosis, Safety, Organization, Daewoong Pharmaceutical, PMA, De novo, Communication

On September 15, 2023, FDA published an update to the guidance document – "Breakthrough Devices Program, Guidance for Industry and Food and Drug Administration Staff.

Key Points: 
  • On September 15, 2023, FDA published an update to the guidance document – "Breakthrough Devices Program, Guidance for Industry and Food and Drug Administration Staff.
  • The FDA considers all of these factors to determine whether a device is 'reasonably expected to provide more effective treatment or diagnosis,'" according to the guidance.
  • Devices with 'Breakthrough Device Designation' benefit from prioritized FDA support during the approval process.
  • This streamlined approach speeds up FDA approval, allowing for quicker entry into the U.S. market compared to other devices.

HanAll Biopharma, Daewoong Pharmaceutical and NurrOn Pharmaceuticals to Showcase Ongoing Parkinson's Disease Program at the 7th Annual Sachs Associates Neuroscience Innovation Forum

Retrieved on: 
Wednesday, December 20, 2023
KRX, Conference, Neuroscience, Daewoong Pharmaceutical, Parkinson's disease, Marines' Memorial Club, Pharmaceutical industry

ROCKVILLE, Md., Dec. 20, 2023 /PRNewswire/ -- HanAll Biopharma (KRX: 009420.KS), Daewoong Pharmaceutical (KRX: 069620.KS), and NurrOn Pharmaceuticals announced their participation in the 7th Annual Sachs Associates Neuroscience Innovation Forum.

Key Points: 
  • ROCKVILLE, Md., Dec. 20, 2023 /PRNewswire/ -- HanAll Biopharma (KRX: 009420.KS), Daewoong Pharmaceutical (KRX: 069620.KS), and NurrOn Pharmaceuticals announced their participation in the 7th Annual Sachs Associates Neuroscience Innovation Forum.
  • The event is scheduled to take place on January 7th, 2024, at the historic Marines' Memorial Club in San Francisco, California.
  • "We are excited to discuss our joint efforts with Daewoong and NurrOn at the Sachs Neuroscience Innovation Forum, a premier event in the neuroscience community.
  • In addition to participating at the Neuroscience Innovation Forum, HanAll will also be attending the 42nd Annual J.P. Morgan Healthcare Conference from January 8th to 11th, 2024.

Daewoong Pharmaceutical Received GMP Certification from Brazilian ANVISA

Retrieved on: 
Tuesday, November 28, 2023
Observation, Regulation, GMP, Good manufacturing practice, Level 4, ANVISA, Daewoong Pharmaceutical, Certification, Pharmaceutical industry

SEOUL, South Korea, Nov. 27, 2023 /PRNewswire/ -- Daewoong Pharmaceutical is pleased to announce that its Osong factory in Korea achieved Good Manufacturing Practice (GMP) certification from the Regulatory Authority of Brazil, ANVISA.

Key Points: 
  • SEOUL, South Korea, Nov. 27, 2023 /PRNewswire/ -- Daewoong Pharmaceutical is pleased to announce that its Osong factory in Korea achieved Good Manufacturing Practice (GMP) certification from the Regulatory Authority of Brazil, ANVISA.
  • Daewoong Pharmaceutical, represented by CEO Seng-ho Jeon and Chang-Jae Lee, proudly announced that their Osong factory passed the Brazilian Good Manufacturing Practice (GMP) inspection with a flawless "Zero" Observation in terms of compliance.
  • This Successful Inspection paves the way for Daewoong Pharmaceutical to further its entry into the Brazilian pharmaceutical market.
  • Daewoong Pharmaceutical, leveraging its smart process, plans to actively pursue GMP certifications in additional countries, including developed nations.

Daewoong Pharmaceutical Received GMP Certification from Brazilian ANVISA

Retrieved on: 
Tuesday, November 28, 2023
Observation, Regulation, GMP, Good manufacturing practice, Level 4, ANVISA, Daewoong Pharmaceutical, Certification, Pharmaceutical industry

SEOUL, South Korea, Nov. 27, 2023 /PRNewswire/ -- Daewoong Pharmaceutical is pleased to announce that its Osong factory in Korea achieved Good Manufacturing Practice (GMP) certification from the Regulatory Authority of Brazil, ANVISA.

Key Points: 
  • SEOUL, South Korea, Nov. 27, 2023 /PRNewswire/ -- Daewoong Pharmaceutical is pleased to announce that its Osong factory in Korea achieved Good Manufacturing Practice (GMP) certification from the Regulatory Authority of Brazil, ANVISA.
  • Daewoong Pharmaceutical, represented by CEO Seng-ho Jeon and Chang-Jae Lee, proudly announced that their Osong factory passed the Brazilian Good Manufacturing Practice (GMP) inspection with a flawless "Zero" Observation in terms of compliance.
  • This Successful Inspection paves the way for Daewoong Pharmaceutical to further its entry into the Brazilian pharmaceutical market.
  • Daewoong Pharmaceutical, leveraging its smart process, plans to actively pursue GMP certifications in additional countries, including developed nations.

Daewoong Pharmaceutical to Participates in CPHI Worldwide 2023, Showcasing Own Novel Drug in the Global Market

Retrieved on: 
Thursday, October 19, 2023
Gastroenterology, Exhibition, Rare, Booth, Hall, GERD, Fira (Barcelona Metro), Partnership, Daewoong Pharmaceutical, Autoimmunity, Pain management, Pharmaceutical industry

SEOUL, South Korea, Oct. 19, 2023 /PRNewswire/ -- Daewoong Pharmaceutical is thrilled to announce its participation in CPHI Worldwide 2023, one of the world's premier pharmaceutical industry exhibitions.

Key Points: 
  • SEOUL, South Korea, Oct. 19, 2023 /PRNewswire/ -- Daewoong Pharmaceutical is thrilled to announce its participation in CPHI Worldwide 2023, one of the world's premier pharmaceutical industry exhibitions.
  • The event is scheduled to take place from the 24th to the 26th of October at Fira Barcelona Gran Via, Spain.
  • Especially, Daewoong Pharmaceutical will accelerate to build partnership with global partner for their own novel drug such as GERD treatment (ingredient: Fexuprazan) and Diabetes treatment (ingredient: Enavogliflozin).
  • Additionally, the company has entered into technology export agreements with 18 countries, including China, further solidifying its global reach.

Daewoong Pharmaceutical to Participates in CPHI Worldwide 2023, Showcasing Own Novel Drug in the Global Market

Retrieved on: 
Thursday, October 19, 2023
Gastroenterology, Exhibition, Rare, Booth, Hall, GERD, Fira (Barcelona Metro), Partnership, Daewoong Pharmaceutical, Autoimmunity, Pain management, Pharmaceutical industry

SEOUL, South Korea, Oct. 19, 2023 /PRNewswire/ -- Daewoong Pharmaceutical is thrilled to announce its participation in CPHI Worldwide 2023, one of the world's premier pharmaceutical industry exhibitions.

Key Points: 
  • SEOUL, South Korea, Oct. 19, 2023 /PRNewswire/ -- Daewoong Pharmaceutical is thrilled to announce its participation in CPHI Worldwide 2023, one of the world's premier pharmaceutical industry exhibitions.
  • The event is scheduled to take place from the 24th to the 26th of October at Fira Barcelona Gran Via, Spain.
  • Especially, Daewoong Pharmaceutical will accelerate to build partnership with global partner for their own novel drug such as GERD treatment (ingredient: Fexuprazan) and Diabetes treatment (ingredient: Enavogliflozin).
  • Additionally, the company has entered into technology export agreements with 18 countries, including China, further solidifying its global reach.

HanAll Biopharma, Daewoong Pharmaceutical and NurrOn Pharmaceuticals Initiate First-in-Human Phase 1 Clinical Study of HL192

Retrieved on: 
Thursday, October 12, 2023
Parkinson's disease, Partnership, Professor, The Michael J. Fox Foundation, MBA, Doctor of Philosophy, Pharmacokinetics, Collaboration, Research, Dyskinesia, Neuron, Ageing, Safety, MAD, Daewoong Pharmaceutical, Clinical research, SAD, MJFF, Neurodegenerative disease, Maintenance, Harvard Medical School, Dopamine, Dopaminergic, Science, PD, KRX, Patient, Pharmaceutical industry

The Phase 1 Study evaluates the safety, tolerability, and pharmacokinetics of both single and multiple doses of orally administered HL192 in healthy participants.

Key Points: 
  • The Phase 1 Study evaluates the safety, tolerability, and pharmacokinetics of both single and multiple doses of orally administered HL192 in healthy participants.
  • KS), Daewoong Pharmaceutical (KRX: 069620.KS), and NurrOn Pharmaceuticals marked a major milestone by dosing the first human healthy participant in their Phase 1 clinical trial, assessing HL192 (NurrOn designation code: ATH-399A) which is being developed for the treatment of Parkinson's disease (PD).
  • HanAll Biopharma, in collaboration with Daewoong Pharmaceutical, solidified a co-development partnership with NurrOn Pharmaceuticals to leverage the therapeutic potential of HL192 across various neurodegenerative diseases.
  • The initial results from the Phase 1 clinical trial of HL192 are expected in the second half of 2024.

2023 South Korea Week kicked off in Shenyang

Retrieved on: 
Thursday, September 28, 2023
Food, Exhibition, Life, LG Electronics, Culture, Electronics, CJ, Publicity Department of the Chinese Communist Party, Multimedia, Hyundai Motor Company, Xita, Health, Investment, Daewoong Pharmaceutical, Film industry, Automotive industry, ROK

2023 China-ROK Friendship Night Gala, is one of the important activities of the South Korea Week.

Key Points: 
  • 2023 China-ROK Friendship Night Gala, is one of the important activities of the South Korea Week.
  • The 2023 South Korea Week is themed "Sharing Opportunities, Developing Together, Creating a Future Together".
  • During the South Korea Week, a symposium for Shenyang and ROK key enterprises will be held.
  • Caption:  2023 South Korea Week kicked off in Shenyang.

Daewoong Pharmaceutical's Fexuprazan takes its first step into Africa Entering into a partnership with Cooper Pharma, the No. 1 pharmaceutical company in Morocco in the field of digestive health

Retrieved on: 
Monday, July 24, 2023
Agreement, Half-life, Gastric acid, Sale, Gastroesophageal reflux disease, GERD, PPI, Pharmaceutical industry, Daewoong Pharmaceutical

The partnering company is Cooper Pharma, a leading Moroccan pharmaceutical company with presence in Africa and Middle East.

Key Points: 
  • The partnering company is Cooper Pharma, a leading Moroccan pharmaceutical company with presence in Africa and Middle East.
  • Cooper Pharma, founded in 1933, has rapidly expanded its businesses in the pharmaceutical industry, keeping its number one ranking position in Morocco's PPI market, which was estimated to be around KRW75.5 billion in revenue last year.
  • Daewoong intends to propose a new innovative solution to GERD drugs building on Cooper Pharma's significant market dominance and network.
  • By entering into this Agreement, Daewoong Pharmaceutical plans to expand its presence of P-CAB drug Fexuprazan in the African pharmaceutical market for gastroesophageal reflux disease (GERD).

HanAll Biopharma and Daewoong Pharmaceutical Co-invest in Vincere Biosciences for Collaborative Opportunities in Parkinson's Disease

Retrieved on: 
Monday, June 12, 2023
KRX, Partnership, Drug development, Mitophagy, Therapy, Mitochondrion, MBA, CMO, Doctor of Philosophy, CDO, Parkinson's disease, Patient, Investment, FMI, Algorithm, Drug discovery, Biology, Artificial intelligence, Pharmaceutical industry, Vincere, Daewoong Pharmaceutical

HanAll Biopharma and Daewoong Pharmaceutical have co-invested in Vincere Biosciences.

Key Points: 
  • HanAll Biopharma and Daewoong Pharmaceutical have co-invested in Vincere Biosciences.
  • The parties will also continue to explore opportunities to expand their collaboration, leveraging Vincere's proprietary AI platform and various mitochondrial targeting efforts.
  • and SEOUL, South Korea, June 12, 2023 /PRNewswire/ -- HanAll Biopharma (KRX: 009420.KS) and Daewoong Pharmaceutical (KRX: 069620.KS) today announced the expansion of their open collaboration strategy by investing in Vincere Biosciences, a Cambridge, MA-based company developing therapeutics targeting mitophagy.
  • With the diverse and complementary research approaches among Vincere, Daewoong, and HanAll, we look forward to finding paths to help Parkinson's patients," said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma.