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- 2026-05-09 09:12:21
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- Celltrion, applies for Phase III U.S. Targeting
- by Lee, Seok-Jun Aug 05, 2022 03:32am
- A clinical trial will be conducted so that Celltrion can alternatively prescribe CT-P17 (Yuflyma), an autoimmune disease treatment developed by itself, with the original Humira. Celltrion announced on the 1st that it recently submitted a global phase 3 to the FDA to secure interchangeability between CT-P17 and Humira. If it is designated as an interchangeable biosimilar, it can be prescribed by replacing the original at a pharmacy without intervention by a doctor. Phase 3 is conducted in 366 patients with plaque psoriasis. Pharmacokinetics, efficacy, and safety will be compared and verified between the group that took multiple intersections between Yuflyma and Humira and the group that administered Humira. Yuflyma is the world's first high-concentration Humira biosimilar that obtained permission from the European Medicines Agency (EMA). It was developed as a formulation that halves drug administration compared to low concentrations and removes citrate, which can cause pain. It started selling in major European countries, and the U.S. has completed a patent agreement with U.S. developer Abbvie so that it can start selling on July 1st next year, and expects FDA approval by the end of this year. Celltrion plans to secure Humira's interchangeable biosimilar status in the U.S. through interchangeable clinical trials with the advantages of Yuflyma's high-concentration formulation. Humira's global sales last year were about $20.69 billion and $17.33 billion in the United States.
- Company
- Oncaspar changed supplier
- by Eo, Yun-Ho Aug 05, 2022 03:28am
- Oncaspar, a combination treatment for acute lymphocytic leukemia (ALL), which has been supplied by developer Servier, is forming a stable prescription maintenance environment. According to related industries, it passed the Drug Committee (DC) of the Big 5 general hospitals, including Samsung Medical Center, Seoul National University Hospital, and Sinchon Severance Hospital. Since May, the supplier has been changed at the rare drug center, but the prescription code has been quickly secured. Oncaspar obtained permission for import items from the MFDS in February last year as a combination therapy with other anti-tumor drugs when treating Acute Lymphoblastic Leukemia (ALL). This drug maximizes the drug circulation half-life through pegylation, dramatically reducing the frequency of administration to be administered once every 14 days compared to L-asparaginase, which was previously administered once every other day. Considering the high incidence of Acute Lymphoblastic Leukemia, in particular in pediatric patients, improved use to allow administration every 14 days is expected to reduce injection burden, physical pain, and hypersensitivity to injection treatments in pediatric patients and patient caregivers suffering from frequent anti-cancer injections. In addition, it is expected to have a positive effect on medical costs such as hospital visits or hospitalization for injection treatment. First approved in 1994 as a secondary treatment for Acute Lymphoblastic Leukemia in the United States and Germany, Oncaspar was recognized as a primary treatment for all Acute Lymphoblastic Leukemia in the United States in 2006. Since birth in Europe in 2016, it has been approved as a combination therapy with other anticancer drugs in children and adults with acute lymphocytic leukemia aged 18. Oncaspar is currently a treatment for Acute Lymphoblastic Leukemia, which is primarily recommended in major international guidelines and treatment protocols such as NCCN, ESMO, and Children's Oncology Group (COG), and is used in 62 countries.
- Company
- Samjin, will develop new drugs with AI company in Canada
- by Lee, Seok-Jun Aug 05, 2022 03:28am
- Samjin Pharmaceutical announced on the 2nd that it has signed a joint research contract for AI new drug development with Cyclica, a Canadian artificial intelligence new drug development platform company. Through the agreement, Samjin Pharmaceutical will propose to Cyclica multiple drug targets currently under review. Cyclica is going to secure candidate materials that are highly likely to be developed by applying AI-based new drug candidate material discovery platform (Ligand DesignTM) technology. Lee Soo-min, head of the Samjin Pharmaceutical Research Center, said, "Joint research using AI technology with Cyclica will significantly reduce the time and cost required to develop new drugs. We will cooperate with leading domestic and foreign research institutes and companies to efficiently discover and develop innovative new drugs through open innovation strategies." Cyclica was selected as one of the world's 13 healthcare AI startups by CB Insights, a technology market research institute in 2020. It is conducting joint research with many domestic and foreign companies including global Big Pharma such as Merck KGaA and AstraZeneca.
- Company
- Chinese partner terminates agreement with Medytox
- by Nho, Byung Chul Aug 04, 2022 06:04am
- Medytox is having difficulty making entry into the Chinese market. At a presentation on ‘Follow-up regarding Bloomage·Medytox joint venture Medybloom's progress' that was held on the 1st, Bloomage Biotechnology announced that “the company will discontinue the partnership with Medytox and seek opportunities with other botulinum toxin companies." As one of the largest hyaluronic acid production and marketing enterprises in the world, Bloomage Biotechnology is known for its professional sales power in China's cosmetic surgery market. With the termination of the partnership, Medytox will now have to seek new venues for entry into the Chinese market without achieving much during the 5 years after establishing the joint venture, MedyBloom China, with Bloomage Biotechnology in 2017. Medytox applied for the approval for its botox product Meditoxin (Neuronox) to the National Medical Products Administration in China in February 2018, but the agenda is pending for over 4 years. Moreover, the global pharmaceutical company Allergan (currently Abbvie) returned the rights of Medytox’s liquid botulinum toxin candidate (MT-10109L) to Medytox in September last year. This return of rights, which occurred 8 years after the company licensed out the development and global sales rights of its liquid botulinum toxin candidate to Allergan in September 2013, was expected to have caused considerable aftermaths for the company. With the termination of the agreement, Medytox will not be able to receive the remaining milestone payments ($262 million/ ₩342.5 billion) from Allergan. Allergan had planned to sell the liquid botulinum toxin in the global market excluding Korea and Japan after undergoing clinical trials and approval processes, but this is also now unclear. With Medytox facing difficulties in 2 of the 3 largest global botulinum toxin markets - the US and China - other competitors are accelerating their market defense and penetration strategies for their botox products. Hugel’s Letybo continues to rank first in the Korean market and is solidifying its position as the market leader with the recent marketing authorization and launch of its botulinum toxin in China. Daewoong’s Nabota has also been increasing its global market sales and shares upon receiving marketing authorization and release in the US. Also, Nabota is coordinating the timing for its entry into the European market, and is on the verge of achieving a grand slam of being approved in all three global major markets as it has completed Phase III clinical trials and is about to receive marketing authorization in China. Meanwhile, Medytox had relayed to the press that “We received a letter from Bloomage regarding the contract termination, but nothing has been finalized. We will be reviewing measures from various angles to come up with the optimal plan for entering the Chinese botulinum toxin market.”
- Company
- MSD Korea to introduce cancer drug Welireg to Korea
- by Eo, Yun-Ho Aug 03, 2022 06:00am
- MSD is expected to introduce another oncology pipeline to Korea. According to industry sources, MSD Korea has submitted an application for the approval of its oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, ‘Welireg (belzutifan),’ to the Ministry of Food and Drug Safety. The drug had been designated as an orphan drug in January for the treatment of Von Hippel-Lindau disease. The indication the company applied in Korea is also for the treatment of adult patients with VHL disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. After being first approved in the US in August, Welireg was also approved in the U.K. and Canada. As a HIF-2α inhibitor, Welireg reduces transcription and expression of HIF-2α target genes associated with cellular proliferation, angiogenesis, and tumor growth. Welireg’s efficacy was demonstrated through the open-label Study 004 trial which investigated 61 VHL-associated RCC patients diagnosed based on a VHL germline alteration and with at least one measurable solid tumor localized to the kidney. Patients enrolled in the trial had other VHL-associated tumors including CNS hemangioblastomas and pNET. The major efficacy endpoint of the clinical trial was the overall response rate (ORR) in patients with VHL-associated RCC as measured by radiology assessment using RECIST v1.1 as assessed by an independent review committee (IRC). Additional efficacy endpoints included duration of response (DoR) and time to response (TTR). In the trial, Welireg showed an ORR of 49% in patients with VHL-associated RCC. All responses were partial responses. The median DoR had not yet been reached, and the DoR among responders that were still responding after at least 12 months was 56%. Median TTR was 8 months. Also, in patients with VHL-associated CNS hemangioblastomas, Welireg showed an ORR of 63%, with a complete response rate of 4% and a partial response rate of 58%.
- Company
- Competitivity of K-Pharma-Bio manufacturing facilities rises
- by Lee, Seok-Jun Aug 03, 2022 06:00am
- The competitiveness of K-Pharma/Biomanufacturing facilities are rising. With more and more companies passing inspections by the US FDA (Food and Drug Administration), the institution considered to have the highest standards, the companies that have passed inspections plan to advance into the global market in earnest. Recieves first cGMP certification in Asia for its oligonucleotide manufacturing plant ST Pharm recently became the first in Asia to receive the US FDA’s Good Manufacturing Practice (cGMP) certification for its oligonucleotide plant. The company received an inspection classification of NAI (No Action Indicated) from FDA’s PAI (pre-approval inspection) of its oligonucleotide factory in Banwol Campus, demonstrating the R&D capability of its facility. With the approval, the company’s oligonucleotide orders are expected to increase. Although ST Pharm had only been exporting drug substances for oligonucleotide treatment used in clinical trials to the US market, the recent FDA cGMP approval will now enable the company to make large-scale exports for commercial use. An ST Pharm official said, “We have 4 more FDA PAIs planned by the first half of next year. This means that FDA approvals of new drugs that ST Pharm supplies drug substances for is imminent. The FDA cGMP approval the company received this time is expected to positively impact the future on-site inspections in plan.” Registered as the first anticancer drug API manufacturing facility in Korea Inist ST’s Osong plant has also recently been registered as a cGMP anticancer drug API manufacturing facility by the FDA. With the registration, the Osong plant became the first cGMP-certified anticancer API manufacturing facility registered as a highly active noncytotoxic anticancer API specialized manufacturing facility A company official said, “With the news spreading, we are receiving a series of love calls from existing and new customers that aim to advance into the US and other advanced pharmaceutical markets. The FDA certification has reaffirmed our global-level API manufacturing facility and quality control capabilities.” By passing FDA inspections, the pre-investment that had been made by Inist ST is also gaining momentum. In October last year, the company started the construction of a 40 billion won 'Global API synthesis cGMP plant' on the site of the Osong plant site to expand its CMO business. The facility is expected to be completed in October. Succeeds in manufacturing COVID-19 mRNA drug substance in addition to finished product Samsung Biologics succeeded in trial manufacture of the mRNA drug substance. With the company's success in establishing the mRNA drug substance facility following the successful CMO of Moderna’s finished mRNA product in the 2nd half of last year, the company has now established a one-stop end-to-end mRNA production system. The company signed aCMO partnership with the US company GreenLight Biosciences for the drug substance of GreenLight’s COVID-19 vaccine candidate at the end of last year. For 7 months since then, the company completed technology transfer, scale-up and established its RNA drug substance manufacturing facility in May this year. Samsung Biologics recently succeeded in the first trial manufacture and has finished preparations for the large-scale commercial manufacturing of the mRNA vaccine drug substance. Trial production is a process verification stage that is carried out before full-scale commercial production. The success of the pilot manufacturing is considered as having full capacity at the cGMP level. The second trial production is expected to take place within this month. A market official said, “An increasing number of pharmaceutical and biopharmaceutical companies have passed FDA’s inspections with their differentiated manufacturing facilities. Such facility R&D is now treated as competitive as the company's material R&D.”
- Company
- Lilly appoints new CEO Christopher J. Stokes
- by jung, sae-im Aug 03, 2022 06:00am
- Christopher J. Stokes, new CEO of Lilly KoreaLilly Korea announced on the 1st that it has appointed Christopher J. Stokes as its new CEO. The new CEO is a pharmaceutical and healthcare expert who has extensive work experience in the global pharmaceutical industry for more than 15 years. He graduated from George Mason University in 2002 and earned a master's degree in public administration from Indiana University Bloomington in 2005. Stokes, who first joined Eli Lilly's U.S. headquarters as a public policy analyst in 2008, has demonstrated excellent performance and positive influence through various roles, from foreign cooperation to rental and drug prices, strategic planning, new product planning, brand policy marketing, and sales management. In particular, he established leadership by serving as Chief Operating Officer (COO) of the Neuroscience Director of Sales for the West Area and Eli Lilly headquarters. From 2020 until recently, he represented Eli Lilly's South Africa and Sub-Saharan Africa offices. CEO Stokes said, "As I am newly appointed as the representative of Lilly in Korea, I will do our best to help more Korean patients lead a better life through Lilly's innovative medicine and further deliver a positive influence on Korean society." Alberto Riva, who previously served as the representative of Lilly Korea, was newly appointed as the representative of the Brazilian branch of Eli Lilly. Since taking office in Lilly Korea in September 2019, President Riva has contributed to the growth of Lilly Korea by supplying treatments in various fields of diseases such as anticancer drugs, diabetes, and autoimmune diseases in Korea.
- Company
- Mundipharma is pushing for its first employee reduction
- by jung, sae-im Aug 03, 2022 06:00am
- The impact of Mundipharma's reduction of narcotic analgesics business is also affecting Korean corporations. A major reorganization is taking place, cutting two-thirds of the department's workforce. According to the pharmaceutical industry on the 3rd, Mundipharma is conducting ERP with the aim of finishing at the end of August. The target is the department in charge of narcotic painkillers among the two Rx departments. This is the first time Mundipharma has conducted an ERP. The voluntary retirement is attributed to global Mundipharma's massive reduction of its narcotic painkillers business. This is because opioid-based narcotic painkillers have emerged as a social problem in the U.S. due to death and addiction caused by overdose, and related pharmaceutical companies have been fined trillions of won. It is considered a "panic drug" and the number of deaths from drug abuse has increased rapidly. According to the CDC, opioid addiction killed about 500,000 people over the past 20 years from 1999. Purdue Pharma, the parent company of Mundipharma, admitted responsibility for overdosing opioids, filed for bankruptcy, and decided to pay 5 trillion won in settlements to 15 states, including New York. At the same time, he also expressed his willingness to sell Mundipharma. Until recently, follow-up measures have continued, such as pushing for the sale of Mundipharma's Chinese subsidiary. Mundipharma has stopped all research and development on narcotic painkillers and has launched a major reduction aimed at abolishing the division. The compensation condition is '2n+8 (two times the number of years of service plus eight months' salary), which is known as the industry's average level. On top of that, the company plans to pay additional special consolation money for annual leave. The problem is that there is a high possibility that ERP applicants will fall short of this due to the large number of job cuts planned by the global community. It is known that less than half of the applicants were applied a day before the actual application deadline. The company's plan to finish ERP within August is also tight. If the gap is large, conflicts between the management trying to fill the number of people somehow and workers to prevent it could arise. Mundipharma reportedly expressed its willingness to complete the ERP smoothly by consulting with the labor union as much as possible. A union official also said, "As global companies are pushing to reduce their business units, Korean corporations are also affected." Mundipharma said, "We will communicate closely with the company regarding ERP and try to solve the problem smoothly."
- Company
- LG Chem Applies to FDA for Phase 3 of Gout New Drug
- by jung, sae-im Aug 03, 2022 06:00am
- LG Chem announced on the 1st that it has applied for a phase 3 clinical trial plan for Tigulixostat, a new gout drug developed by the U.S. Food and Drug Administration (FDA). This is the first time that LG Chem has started phase 3 clinical trials of new drugs in global regions such as the U.S. The company's strategy is to significantly expand its bio business area centered on domestic demand and emerging markets to the U.S. and Europe. This clinical trial evaluates safety and effectiveness compared to placebo in 350 adult gout patients with hyperuricemia in multiple countries, including the United States, at the point of six months of taking Tigulixostat. The primary evaluation index was set as the proportion of patients who reached serum uric acid concentration of 6 mg/dL for 6 months. LG Chem will also apply to the FDA for a comparative test plan with Allopurinol, the primary treatment ingredient for gout patients with hyperuricemia. Its strategy is to prove differentiated efficacy and long-term use safety through recruiting large-scale global test groups. LG Chem aims to sell globally from 2028 after obtaining approval for item approval as a first treatment from the U.S. FDA in 2027. Tigulixostat inhibits the expression of the enzyme xanthine oxidease that produces uric acid, which is the main cause of gout. As a result of the U.S. Phase II results, Tigulixostat showed a rapid and strong uric acid drop effect, the company explained. According to the global market research firm CMI (Coherent Market Insights), the global gout treatment market is expected to expand from 3 trillion won in 2019 to 5 trillion won in 2027 due to aging population and increasing obese population. Currently, there are 35 million patients diagnosed with gout worldwide, of which the number of patients in the U.S. and China is estimated to be 10 million and 14 million, respectively. "Tigulixostat global phase 3 will be a solution to further strengthen LG Chem's new drug clinical, licensing, production, and sales capabilities," said Sohn Ji-woong, head of the Life Science Business Division. "We will lay a new turning point in the gout treatment market through clinical strategies and preemptive commercialization preparation."
- Company
- SK Bioscience has applied for CMA of SKY Covione
- by Kim, Jin-Gu Aug 02, 2022 06:02am
- SK Bioscience announced on the 29th that it has applied for Conditional Marketing Authorization (CMA) of the COVID-19 vaccine to MHRA, a British pharmaceutical regulator. The product name in the UK and Europe is SKY Covione. SK Bioscience explained that it has been conducting a Rolling Review since March to receive prompt approval from MHRA. Rolling Review is a system that quickly evaluates promising vaccines and treatments by submitting efficacy, safety, and quality data sequentially before applying for final permission. SK Bioscience submitted additional phase 3 clinical data recently secured to MHRA. MHRA will begin a full-fledged review for SKY Covione's CMA. Starting with the UK, SK Bioscience plans to apply for CMA to the European Medicines Agency (EMA) in the future and apply for registration on the World Health Organization's Emergency Use List (EUL). Ahn Jae-yong, president of SK Bioscience, said, "This application for permission will take the first step to introduce a domestic COVID-19 vaccine with excellent safety and immunity to the global big Pharma-centered COVID-19 vaccine market." Starting with the application for CMA in the UK, we will introduce Korea's technology to the global vaccine market through Europe and WHO EUL listing, he said. "In addition, it will contribute to restoring safe daily life through COVAX Facility." In June, SK Bioscience was approved for "SKY Covione multi injection" as the first domestic COVID-19 vaccine. SKY Covione is a COVID-19 vaccine developed by SK Bioscience based on its global network. It was jointly developed by IPD and SK Bioscience at the University of Washington, USA, and GSK's Adjuvant AS03 was applied to strengthen the immune response. It received development cost support from BMGF and CEPI from the early stage of development, and plans to be supplied to the global market through COVAX Facility after acquiring WHO EUL. SKY Covione demonstrated excellent immunogenicity and safety during basic vaccination through phase 3 clinical trials of 4,037 adults in five countries at home and abroad. Additional studies in phase 1/2 of the SKY Covione clinical trial showed a high immune response to the omicron mutation (BA.1). SK Bioscience is conducting clinical trials for ▲ heterogeneous booster shots and ▲ of the same kind of booster shot , and it plans to conduct ▲ an additional study to confirm the response effect of omicron mutations.
