DAEWOONG PHARMACEUTICAL CO., LTD
2023-1026
Daewoong Pharmaceutical announces '3E Global Hyper-Competitive Strategy' at CPHI 2023... Aiming for USD 745M in novel drug sales by 2030
·Announces the 3E strategy for global expansion in Barcelona, Spain
·Emphasizes rapid global product approval, simultaneous expansion of the new drug lineup, and unparalleled excellence in production
·Accelerates global expansion of Fexuclue and Envlo, aiming to be Korea's first global big pharma
Daewoong Pharmaceutical, which has succeeded in novel drug development for two consecutive years, ambitiously announced its 'global hyper-competitive strategy' and revealed its goal to achieve '1 product, 1 trillion won' with Fexuclue.
Daewoong Pharmaceutical (CEO Seng-ho Jeon and Chang-jae Lee) announced on the 26th that they unveiled their global market entry strategy for their self-developed novel drug and their vision to achieve 745M USD in sales at the 'CPHI Worldwide 2023' (hereinafter referred to as CPHI), the world's largest pharmaceutical and bio exhibition held in Barcelona, Spain.
Daewoong Pharmaceutical has participated in CPHI for nine consecutive years. This year, Daewoong presented a blueprint to accelerate their global expansion, aiming to achieve 745M USD in global sales by 2030, focusing on self-developed novel drugs, including 'Fexuclue' for gastroesophageal reflux disease (GERD) treatment and 'Envlo' for diabetes treatment.
Daewoong Pharmaceutical has announced its ambition to become Korea's leading pharmaceutical company and the country's first global big pharma. They are driving this vision with their '3E Hyper-Competitive Strategy', which encompasses ▲Rapid global product approval (Efficiency) ▲Simultaneous expansion of novel drugs line-up (Extension) and ▲Unparalleled production excellence in the nation's 4-stage smart factory that incorporates AI (Excellence).
To begin with, Daewoong Pharmaceutical is accelerating its global expansion through its 'Rapid Global Product Approval (Efficiency) Strategy'. By pursuing global product approvals and contracts concurrently during the novel drug development phase, Daewoong can expedite both domestic launches and overseas expansions. This strategy is designed to swiftly penetrate the global market within the patent period of the novel drug. The objective is to narrow the gap between domestic and overseas launches before the patent expires, thus securing a leading position for the original novel drug.
In practice, just one year after its domestic launch, Daewoong Pharmaceutical's Fexuclue sought product approvals in 12 countries and secured approval from four within that year. Beginning with its launch in the Philippines last July, it embarked on a full-fledged global expansion. This pace is unmatched and the fastest among domestically produced novel drugs.
Secondly, Daewoong Pharmaceutical has introduced its 'Simultaneous Expansion of Novel Drug Line-up (Extension)' strategy. This approach aims to swiftly transform their self-developed new drugs into blockbuster medications by rapidly expanding the combination drug line-up and their indications.
Daewoong Pharmaceutical officially launched 'Envlo', the first SGLT-2 inhibitor series diabetes treatment in Korea, last May and obtained domestic approval for the combination drug EnvloMet (active ingredients: enavogliflozin, Metformin hydrochloride) in just a month. Moreover, they plan to launch EnvloMet within this year, anticipating synergy with the single agent. Additionally, they are developing the world's first ophthalmic treatment for diabetic retinopathy using the main ingredient of Envlo, 'enavogliflozin'. In September, they received approval for the Phase 1 clinical trial plan and are currently in progress. Currently, only antibody treatments that involve directly injecting drugs into the eye are developed for the treatment of diabetic retinopathy. However, by developing the world's first nano eye drop form, Daewoong aims to significantly improve the convenience of medication, offering a new treatment option for patients suffering from refractory eye diseases. It is expected that this could be a game-changer that could replace antibody treatments.
While Envlo seeks to enhance its marketability through combination drug development, Fexuclue aims to broaden its market reach by obtaining additional indications. It is being developed for five indications: ▲gastritis, ▲maintenance therapy following treatment of non-erosive gastroesophageal reflux disease, ▲prevention of ulcers induced by NSAIDs, ▲eradication of H. pylori (in combination with antibiotics), and ▲treatment of NERD. The objective is to position Fexuclue as a versatile treatment option for gastrointestinal diseases. The indication for gastritis, slated for release in the first half of next year, will be the first in the P-CAB series to be exclusively approved for Fexuclue, and it has already received its Phase 3 clinical trial approval.
Thirdly, Daewoong is distinguishing themselves from competitors by emphasizing unparalleled production excellence (Excellence). Daewoong Pharmaceutical completed the Osong Smart Factory in 2017, and promptly integrated AI and achieved 'Level 4 of Corporate Manufacturing Innovation Capability'. The Daewoong Osong Smart Factory is a cutting-edge facility that harnesses ICT (Information and Communication Technology) to unify all production processes, enabling the creation of customized products for customers in minimal time and at reduced costs. This state-of-the-art production facility is a pivotal competitive edge, facilitating swift global GMP certification.
Recently, Daewoong Pharmaceutical secured the bGMP certification from Brazil's National Health Surveillance Agency (ANVISA), renowned for its rigor comparable to the U.S. FDA's cGMP, in a single attempt without any issues raised. The inspection team from ANVISA visited Daewoong Pharmaceutical's Osong Smart Factory between the 4th and 7th of the previous month to meticulously examine the production processes for the novel drugs, Fexuclue and Envlo. Word has it that the inspection team was notably impressed by the exceptional standards of the Osong Smart Factory, which has achieved Level 4 status. This bGMP certification has considerably expedited the export timeline for Fexuclue and Envlo to Brazil.
The future market potential for Daewoong Pharmaceutical's new drugs, Fexuclue and Envlo, is substantial. Both gastrointestinal diseases and diabetes represent markets with significant global demand. Combined, the value of these two markets easily surpasses 100B USD. Data from global market research agencies indicate that the worldwide market for gastroesophageal reflux disease is estimated at around 16B USD, while the market for type 2 diabetes stands at 70B USD. The P-CAB series, to which Fexuclue belongs, and the SGLT-2 inhibitor series, to which Envlo belongs, are anticipated to rapidly supplant existing drugs. Daewoong Pharmaceutical's two new drugs are being assessed as potential global blockbusters for the future.
Seng-ho Jeon, the CEO of Daewoong Pharmaceutical, remarked, "With the FDA-approved Nabota, and the novel drugs Fexuclue and Envlo, we are entering the global market at an unprecedented speed compared to other domestically produced new drugs due to our '3E Hyper-Competitive Strategy.'" He added, "By 2030, we aim to achieve a sales revenue of USD 745M from our novel drugs, become the number one pharmaceutical company in Korea, and also take a leap to become the first global big pharma from Korea."
·Announces the 3E strategy for global expansion in Barcelona, Spain
·Emphasizes rapid global product approval, simultaneous expansion of the new drug lineup, and unparalleled excellence in production
·Accelerates global expansion of Fexuclue and Envlo, aiming to be Korea's first global big pharma
Daewoong Pharmaceutical, which has succeeded in novel drug development for two consecutive years, ambitiously announced its 'global hyper-competitive strategy' and revealed its goal to achieve '1 product, 1 trillion won' with Fexuclue.
Daewoong Pharmaceutical (CEO Seng-ho Jeon and Chang-jae Lee) announced on the 26th that they unveiled their global market entry strategy for their self-developed novel drug and their vision to achieve 745M USD in sales at the 'CPHI Worldwide 2023' (hereinafter referred to as CPHI), the world's largest pharmaceutical and bio exhibition held in Barcelona, Spain.
Daewoong Pharmaceutical has participated in CPHI for nine consecutive years. This year, Daewoong presented a blueprint to accelerate their global expansion, aiming to achieve 745M USD in global sales by 2030, focusing on self-developed novel drugs, including 'Fexuclue' for gastroesophageal reflux disease (GERD) treatment and 'Envlo' for diabetes treatment.
Daewoong Pharmaceutical has announced its ambition to become Korea's leading pharmaceutical company and the country's first global big pharma. They are driving this vision with their '3E Hyper-Competitive Strategy', which encompasses ▲Rapid global product approval (Efficiency) ▲Simultaneous expansion of novel drugs line-up (Extension) and ▲Unparalleled production excellence in the nation's 4-stage smart factory that incorporates AI (Excellence).
To begin with, Daewoong Pharmaceutical is accelerating its global expansion through its 'Rapid Global Product Approval (Efficiency) Strategy'. By pursuing global product approvals and contracts concurrently during the novel drug development phase, Daewoong can expedite both domestic launches and overseas expansions. This strategy is designed to swiftly penetrate the global market within the patent period of the novel drug. The objective is to narrow the gap between domestic and overseas launches before the patent expires, thus securing a leading position for the original novel drug.
In practice, just one year after its domestic launch, Daewoong Pharmaceutical's Fexuclue sought product approvals in 12 countries and secured approval from four within that year. Beginning with its launch in the Philippines last July, it embarked on a full-fledged global expansion. This pace is unmatched and the fastest among domestically produced novel drugs.
Secondly, Daewoong Pharmaceutical has introduced its 'Simultaneous Expansion of Novel Drug Line-up (Extension)' strategy. This approach aims to swiftly transform their self-developed new drugs into blockbuster medications by rapidly expanding the combination drug line-up and their indications.
Daewoong Pharmaceutical officially launched 'Envlo', the first SGLT-2 inhibitor series diabetes treatment in Korea, last May and obtained domestic approval for the combination drug EnvloMet (active ingredients: enavogliflozin, Metformin hydrochloride) in just a month. Moreover, they plan to launch EnvloMet within this year, anticipating synergy with the single agent. Additionally, they are developing the world's first ophthalmic treatment for diabetic retinopathy using the main ingredient of Envlo, 'enavogliflozin'. In September, they received approval for the Phase 1 clinical trial plan and are currently in progress. Currently, only antibody treatments that involve directly injecting drugs into the eye are developed for the treatment of diabetic retinopathy. However, by developing the world's first nano eye drop form, Daewoong aims to significantly improve the convenience of medication, offering a new treatment option for patients suffering from refractory eye diseases. It is expected that this could be a game-changer that could replace antibody treatments.
While Envlo seeks to enhance its marketability through combination drug development, Fexuclue aims to broaden its market reach by obtaining additional indications. It is being developed for five indications: ▲gastritis, ▲maintenance therapy following treatment of non-erosive gastroesophageal reflux disease, ▲prevention of ulcers induced by NSAIDs, ▲eradication of H. pylori (in combination with antibiotics), and ▲treatment of NERD. The objective is to position Fexuclue as a versatile treatment option for gastrointestinal diseases. The indication for gastritis, slated for release in the first half of next year, will be the first in the P-CAB series to be exclusively approved for Fexuclue, and it has already received its Phase 3 clinical trial approval.
Thirdly, Daewoong is distinguishing themselves from competitors by emphasizing unparalleled production excellence (Excellence). Daewoong Pharmaceutical completed the Osong Smart Factory in 2017, and promptly integrated AI and achieved 'Level 4 of Corporate Manufacturing Innovation Capability'. The Daewoong Osong Smart Factory is a cutting-edge facility that harnesses ICT (Information and Communication Technology) to unify all production processes, enabling the creation of customized products for customers in minimal time and at reduced costs. This state-of-the-art production facility is a pivotal competitive edge, facilitating swift global GMP certification.
Recently, Daewoong Pharmaceutical secured the bGMP certification from Brazil's National Health Surveillance Agency (ANVISA), renowned for its rigor comparable to the U.S. FDA's cGMP, in a single attempt without any issues raised. The inspection team from ANVISA visited Daewoong Pharmaceutical's Osong Smart Factory between the 4th and 7th of the previous month to meticulously examine the production processes for the novel drugs, Fexuclue and Envlo. Word has it that the inspection team was notably impressed by the exceptional standards of the Osong Smart Factory, which has achieved Level 4 status. This bGMP certification has considerably expedited the export timeline for Fexuclue and Envlo to Brazil.
The future market potential for Daewoong Pharmaceutical's new drugs, Fexuclue and Envlo, is substantial. Both gastrointestinal diseases and diabetes represent markets with significant global demand. Combined, the value of these two markets easily surpasses 100B USD. Data from global market research agencies indicate that the worldwide market for gastroesophageal reflux disease is estimated at around 16B USD, while the market for type 2 diabetes stands at 70B USD. The P-CAB series, to which Fexuclue belongs, and the SGLT-2 inhibitor series, to which Envlo belongs, are anticipated to rapidly supplant existing drugs. Daewoong Pharmaceutical's two new drugs are being assessed as potential global blockbusters for the future.
Seng-ho Jeon, the CEO of Daewoong Pharmaceutical, remarked, "With the FDA-approved Nabota, and the novel drugs Fexuclue and Envlo, we are entering the global market at an unprecedented speed compared to other domestically produced new drugs due to our '3E Hyper-Competitive Strategy.'" He added, "By 2030, we aim to achieve a sales revenue of USD 745M from our novel drugs, become the number one pharmaceutical company in Korea, and also take a leap to become the first global big pharma from Korea."
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Daewoong Pharma published this content on 26 October 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 26 October 2023 00:12:38 UTC.
