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- 2026-04-04 16:37:08
- Opinion
- [Reporter’s View] Vaccine sovereignty only during epidemics
- by Son, Hyung-Min Sep 05, 2024 05:51am
- The Korea Disease Control and Prevention Agency recently announced that it will support messenger ribonucleic acid (mRNA) vaccines in preparation for the next pandemic. The government will support research and development from preclinical to Phase III trials, focusing on companies with the potential to localize mRNA vaccine platforms. Candidate companies include GC Biopharma, Samyang Holdings, and ST Pharm, which have a history of developing COVID-19 vaccines. The rapid increase in COVID-19 cases in a short period of time has raised the need for domestic vaccine development. Securing vaccine sovereignty is being discussed again following the peak of the COVID-19 pandemic from 2020 to 2022. The government has consistently claimed that it will localize COVID-19 vaccines. However, the government gradually reduced the scale of support with the easing down of the pandemic. In fact, there were vaccine candidates from the domestic pharmaceutical and biotech industry that entered Phase I, Phase II, and Phase III clinical trials, but some abandoned the development of new drugs due to high costs incurred during late-stage clinical trials. Genexine, which started COVID-19 vaccine development, abruptly discontinued its R&D in 2022 after conducting Phase II/III clinical trials. The company cited oversaturation of the market and failure to receive foreign approvals, but also cited a lack of government support. Genexine reportedly had close to KRW 10 billion in government funding. In June, Eubiologics also canceled plans for domestic clinical trials of its COVID-19 vaccine. Various domestic pharma and biotech companies, including Eyegene, ST Pharm, GenOne Life Science, Auratis, Telcon RF Pharm, and Quratis, have been working on COVID-19 vaccines, but their movement has been slow since COVID-19 turned into an endemic. 4 years have passed since the outbreak of the COVID-19 pandemic, but minimal progress has been made in the domestic vaccine development scene has been minimal. SK Bioscience's vaccine SKYCovione and Celltrion's treatment Regkirona have been developed for COVID-19, but they lack utility. SKYCovione and Regkirona are not able to respond to new COVID-19 mutations. Many infectious disease experts emphasize the need for government support for domestic companies to develop local vaccines. This is because the pharmaceutical industry has to invest a lot of money in research and development (R&D), while the expected return is small. According to the Ministry of Science and ICT, the R&D budget for infectious diseases reached KRW 438.5 billion in 2021 and KRW 508.1 billion in 2022, when COVID-19 was at its peak. However, the budget dropped to KRW 413 billion in 2023, the year the pandemic began, and did not even reach KRW 300 billion in 2024. While the budget for infectious disease R&D has declined, the cost of purchasing overseas vaccines has snowballed. The government reportedly spent more than KRW 7 trillion on overseas COVID-19 vaccine purchases from 2020 to last year. As for COVID-19 treatments, the budget for purchases this year is KRW 179.8 billion, but the rising number of patients has led to the need for additional funding. The COVID-19 drugs being procured are all new drugs produced by foreign companies. It is said that it has become difficult for the pharmaceutical industry to develop vaccines as the scale of the government’s project has shrunk and support reduced. This is in contrast to the trend overseas. The U.S. has invested KRW 41 trillion in mRNA platforms to help Pfizer and Moderna commercialize their vaccines. In China, CSPC Innovation Pharma developed an mRNA vaccine, SYS6006, in March last year and received approval from its country's health authorities. In Japan, Daiichi Sankyo also secured vaccine sovereignty in September last year with the development of its mRNA vaccine, Daiichirona. Daiichi Sankyo is continuing its research on targeting the dominant variant through its mRNA platform. The Korean government decided to support the specific field of mRNA upon the rise of confirmed COVID-19 cases. The timing is indeed a bit late, as it seems like Korea is following the steps of neighboring East Asian countries that already succeeded in developing mRNA vaccines. Couldn’t they have prepared for the next pandemic by increasing the budget in the post-pandemic stable state? Vaccine sovereignty cannot be secured by mending the barn after the horse is stolen.
- Company
- New lymphoma drug 'Columvi' reapplies for reimbursement
- by Eo, Yun-Ho Sep 05, 2024 05:51am
- Product photo of Columvi. 'Columvi,' a first-in-class bispecific antibody for lymphoma treatment, will make another attempt to be considered for reimbursement listing. According to industry sources, Roche Korea has recently submitted a reimbursement application for the CD20·CD3 bispecific antibody Diffuse Large B-Cell Lymphoma (DLBCL) treatment Columvi (glofitamab). The drug was initially considered for the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service (HIRA) in July but failed to set reimbursement criteria. Whether Columvi will successfully win reimbursement listing gathers attention. Columvi was approved in December last year as a treatment for patients with relapsed or refractory DLBCL after two or more lines of previous systemic therapy. The drug is a third-line treatment like Kymriah (tisagenlecleucel), Novartis Korea's Chimeric Antigen Receptor (CAR)-T Cell therapy. Because these two drugs provide different advantages, physicians will likely choose between them, considering the patient's condition and circumstances. The efficacy of Columvi was demonstrated in the Phase 1/2 NP30179 study, which involved 155 patients with relapsed or refractory DLBCL after two or more lines of previous systemic therapy. The results showed that 40% of the patients had complete response (CR) and 52% had objective response rate (ORR) after Columvi treatment. This effect was consistent in the sub-group analysis. The most common adverse reaction was cytokine release syndrome (CRS). Additionally, the company presented the Phase 3 STARGLO study, demonstrating Columvi's effect in improving overall survival (OS), in a recently held European Hematology Association (EHA) meeting (EHA 2024), adding positive data. The STARGLO study enrolled patients with relapsed or refractory (R/R) DLBCL after two or more lines of previous systemic therapy or those who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant. The primary analysis (a median follow-up of 11.3 months) showed that Columvi in combination with gemcitabine plus oxaliplatin (GemOx) reduced the risk of death by 41% than Rituxan in combination with GemOx, improving the primary endpoint OS significantly. Meanwhile, DLBCL is caused by uncontrolled growth or proliferation of 'B cells,' which play a role in keeping the body healthy, and it accounts for about 40% of all non-Hodgkin lymphoma (NHL). DLBCL is a fast-advancing and aggressive subtype, and it shows a poor prognosis with more treatments. Before Columvi became available, patients with relapsed or refractory DLBCL after two or more lines of previous systemic therapy had limited third-line treatment options that could be readily used.
- Company
- More treatment options for rheumatoid arthritis available
- by Hwang, Byung-woo Sep 05, 2024 05:51am
- "Patients with rheumatoid arthritis differ by age, duration of illness, accompanying disease, self-injection capability, risk factor for complications, and economic status. Therefore, drug selection considering an individual's condition is crucial." Rheumatoid arthritis is caused by abnormally activated immune cells attacking joints, thereby inducing inflammation and pain. If not treated early, repeated inflammation over time could result in joint deformities and loss of function. Along with improved disease awareness, physicians are provided with more treatment options that they can use. For example, Janus Kinase (JAK) inhibitors brought a paradigm shift to rheumatoid arthritis treatment. Professor Hae-Rim Kim, the Department of Rheumatology at Konkuk University School of MedicineProfessor Hae-Rim Kim, the Department of Rheumatology at Konkuk University School of Medicine, assessed that oral JAK inhibitors substantially helped solve unmet needs in clinical fields. Recently, JAK inhibitors have been used as a vital treatment option for patients with rheumatoid arthritis and ankylosing spondylitis. Kim explained, "Rheumatoid arthritis occurs when autoimmune reactions cause inflammation in the thin tissue lining of joints. As a result, damages to cartilages and bones surrounding the joints lead to loss of joint function, causing permanent dysfunctions." Kim added, "JAK inhibitors that can be orally administered and have almost similar effects now enable patients to manage arthritis effectively." However, concerns for 'safety' were raised after JAK inhibitors were reported to come with adverse cardiovascular events in 2021. At that time, the U.S. Food and Drug Administration (FDA) cautioned that JAK inhibitors have the risk of cardiac disorders and cancer. The Ministry of Food and Drug Safety (MFDS) in South Korea also distributed safety documents. Ultimately, the U.S. FDA decided to add a new black box warning to JAK inhibitors, citing major adverse cardiovascular events (MACE), thrombosis, and death. Although a causal association between the drug and adverse reactions has not been demonstrated, the safety issue of JAK inhibitors has not bee resolved. Because of this, warnings have been issued to clinical practices. Regarding this matter, Kim emphasized the individualized treatment regimem to consider each patient's condition. This means that the selection of drugs cosidering an individual's condition is crucial. Kim said, "For patients who are at high risks, such as those who are seniors, have tumors, or have cardiovascular diseases, drugs with different mechanisms of actions is considered first ahead of the use of JAK inhibitors," and added, "Because JAK inhibitors could increase the risk for infections, especially shingles, various immunizations are recommended to prevent such infections before the use of the drug. Vaccines for pneumonia, shingles, and influenza could be considered, and patients with latent tuberculosis must undergo prior treatment." "Special exemption of calculation provisions must be improved for rheumatoid arthritis" When asked if there could be system-wise improvements, Kim mentioned a 'special exemption of calculation provisions' of the National Health Insurance system. Rheumatoid arthritis is caused by autoimmune reactions of immune cells against specific proteins in the body. It is known that rheumatoid factor and anti-CCP antibodies are the leading causes of the disease. Rheumatoid factor or anti-CCP antibodies are found in 70-80% of all patients with rheumatoid arthritis. The remaining patients who do not have those factors are categorized as seropositive and seronegative rheumatoid arthritis. Previous studies have shown that seropositive rheumatoid arthritis patients tend to have more severe disease and poorer prognosis compared to seronegative patients. As a result, when 'special exemption of calculation provisions' was implemented, only seropositive patients received the benefits. In other words, seronegative patients, nearly 20% of all patients with rheumatoid arthritis, do not benefit from 'special exemption of calculation provisions.' Kim said, "Unfortunately, approximately 20% of rheumatoid arthritis patients are excluded from receiving 'special exemption of calculation provisions' for severe diseases because they test negative for rheumatoid factor and anti-CCP antibodies. As a result, the treatment costs a lot." Kim added, "There should be systemic improvements to ensure these patients are also included in the special provisions." "Currently, biological agents and targeted synthetic anti-rheumatic drugs can only be used at least six months after the first-line treatment, which limits the ability to provide early and aggressive treatment," Kim added. "There is a need to ease the reimbursement criteria for drug use based on physicians' clinical decisions." Lastly, Kim emphasized the importance of early diagnosis of rheumatoid arthritis and complications management. Kim explained, "Big differences in prognosis are reported between patients who dive into treatment after early diagnosis and those who have delayed diagnosis and treatments over two years. Individuals who have experienced unexplained small joint swelling and pain over six months are recommended to see physicians," and added, "The most common cause of death of patients with rheumatoid arthritis is surprisingly cardiovascular disease. Assessment of the risk of disease-related complications and an appropriate treatment addressing these risks are important." Lastly, Kim advised, "Patients who receive treatment earlier have a good prognosis, and drugs with different mechanisms of action are currently available, as well as drugs under development," and added, "Patients who are diagnosed with rheumatoid arthritis do not need to be afraid nor be disappointed, and I wish the best for patients to live healthy lives by seeking treatments proactively."
- Company
- J&J appoints Christian Rodseth as new Managing Director
- by Hwang, Byung-woo Sep 05, 2024 05:51am
- Christian Rodseth was appointed as the new Managing Director for J&J Janssen Korea, a subsidiary of Johnson and Johnson (J&J)'s pharmaceutical division in South Korea, announced on September 4th that Christian Rodseth was appointed as the new Managing Director for J&J's pharmaceutical division in North Asia as of September 2nd. As the CEO of Janssen Korea and Managing Director for J&J's pharmaceutical division in North Asia, Rodseth will lead the North Asia cluster, including South Korea, Taiwan, and Hong Kong. Rodseth joined J&J as a sales representative in South Africa in 2006 and has held sales, marketing, and strategic planning positions in various countries, including Africa, Europe, and the United States. Until recently, Rodseth served as the Managing Director for five European countries, including Greece, Poland, and Romania, and led significant business growth. He has also contributed to improving patient accessibility to innovative treatments by holding positions in pharmaceutical associations in various countries. Rodseth said, "I am pleased to lead the team with expertise in leading healthcare innovation in South Korea, Taiwan, and Hong Kong markets," and added, "I hope to solve complicated diseases by keeping close communication with physicians, the government, and patients and to improve patient accessibility to innovative medicines. Ultimately, I hope these efforts could save patient lives and change lifestyles." Rodseth graduated from University of the Witwatersrand in South Africa and Warwick Business School in the U.K.
- Policy
- ‘Policy support enabled the prompt approval of Envlo’
- by Lee, Hye-Kyung Sep 04, 2024 05:49am
- The backstory of Daewoong Pharmaceutical's Envlo 0.3mg (enavogliflozin), which is a representative success case of the MFDS’s expedited review process, was introduced recently. The government’s policy support for the commercialization of innovative products was what enabled Envlo’s clinical trial to approval in just 5 years. In general, diabetes drugs that require long-term use take an average of 7 years from clinical trials to approval. However, with MFDS support and Daewoong Pharmaceutical's R&D capabilities, Envlo succeeded in shortening this period to 5 years. The MFDS published the 'Successful Medical Product Commercialization Casebook' and revealed not only Envlo, but also cases such as Roche Korea’s Lunsumio Inj (mosunetuzumab) and Recordati Korea's Qarziba Inj 4.5mg/ml (dinutuximab beta). Envlo Tab= Envlo Tab, the first product to be subject to expedited review, received a quality review in advance through a rolling review process prior to its approval. During the approval review process, the company was able to closely communicate with the reviewer about the submitted data through product briefings and supplementary briefings, and the MFDS ordered data preparation guidance and requested supplementary material in real-time. While the average time to the approval of a new drug in Korea is 314 days, Envlo was approved in 243 days, reducing the time required by 71 days. Based on this, Daewoong Pharmaceutical licensed out Envlo’s technology for KRW 108.2 billion to Mexico and Brazil in February last year and for KRW 77.1 billion to Russia/CIS in December of the same year. The company is currently undergoing approval reviews in 12 countries, including Mexico, Saudi Arabia, and the Philippines. The MFDS said, “The rapid approval achieved by the collaboration of public and private sectors is expected to lead to the overall growth of the domestic pharmaceutical industry in the long run. The expedited review of Envlo was an opportunity to experience the MFDS’s determination to support domestically developed new drugs.” “After being designated as the first drug subject to expedited review, we communicated with the reviewers frequently through briefings and technical consultations, which helped clarify the direction of our future preparations,” said Jong-won Choi, Executive Director of the Development Division at Daewoong Pharmaceutical. ”The approval period was shorter than expected by two months with the help of the rolling review system.” Lunsumio Inj= Lunsumio Inj, a first-in-class CD20 and CD3 bispecific antibody treatment was designated as the No.1 GIFT drug, which allowed the review to begin immediately upon the submission of the application. In particular, the fast-track designation and approval process fostered the conditions for faster access for patients, as domestic approval was prepared without any time lag from overseas regulatory review. The number of patients with recurrent/refractory vesicular lymphoma in Korea increased from 885 in 2018 to 1,770 in 2022, and the number of patients is still increasing every year, increasing the disease burden on society. “We were able to communicate with the reivewee frequently and quickly prepare the necessary materials for the review,” the MFDS said, adding that ”we were able to grant marketing authorization faster than the usual drug license review period.” Qarziba Inj=Qarziba, which is a treatment for high-risk and relapsed/refractory neuroblastoma was eligible to GIFT and other support benefits in the approval process as the No.1 ‘approval-evaluation-drug pricing negotiation project.’ The reviewers from the Expedited Review Division communicated frequently with the company representatives and actively delivered their inquiries and comments on the submitted data. In particular, one of the benefits of GIFT is the opportunity to share opinions through supplementary briefings and frequent non-face-to-face consultations, which can be utilized through wired and wireless communication such as phone calls and emails, as well as opportunities such as product briefings and supplementary briefings. In the case of safety and efficacy, criteria, and test methods, the first round of supplementation was already made, and the reviewers provided detailed and professional counseling in the video supplementation session requested by the company.
- Company
- New drug Voranigo receives orphan drug designation in Korea
- by Eo, Yun-Ho Sep 04, 2024 05:49am
- Voranigo, the first new malignant brain tumor drug introduced in 20 years, has received an orphan drug designation in Korea. The Ministry of Food and Drug Safety announced so through an official orphan drug designation notice on the 3rd. Specifically, the drug is for the treatment of IDH-mutated diffuse glioma. Voranigo can be used to treat patients with low-grade glioma who are susceptible to isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) mutation. Voranigo (vorasidenib) is an IDH1/2 dual inhibitor class drug developed by the multinational pharmaceutical giant Servier that targets a difficult-to-treat brain tumor, gliomas (including oligodendrogliomas and astrocytomas). The drug received final approval from the U.S. Food and Drug Administration (FDA) on March 6 and is in the process of being approved in Europe and other countries around the world. The efficacy of Voranigo was demonstrated through the Phase III INDIGO trial. The results of the study were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting last year. Results showed that the drug significantly reduced the risk of tumor progression or death by 61% compared with placebo in patients with residual or recurrent grade 2 IDH-mutant glioma, and reduced the risk for further treatment by 74%. These patients had not previously undergone any treatment other than surgery. The trial also showed that Voranigo was well tolerated, and its safety profile was consistent with the results observed in the Phase 1 trial. Glioma is the most common primary malignant brain tumor in adults, and nearly all (grade 2 diffuse glioma) adult patients have IDH1 or IDH2 mutations. The treatments for these patients are all off-label (drugs licensed for other uses) and not formally approved. In addition to Voranigo monotherapy, Servier is currently conducting a clinical trial on Voranigo in combination with MSD's immuno-oncology drug Keytruda (pembrolizumab) in patients with relapsed or advanced IDH1-mutant glioma. The company already owns a pipeline of IDH inhibitors, including Tibsovo (an IDH1 inhibitor) and Idhifa (an IDH2 inhibitor).
- Company
- Yuhan's investment in US subsidiary total KRW 27B over 5 yrs
- by Chon, Seung-Hyun Sep 04, 2024 05:48am
- Yuhan Corporation has invested KRW 3.9 billion additionally to the U.S.-based subsidiary of the company. The company invested KRW 27 billion over the past five years, expanding support for global entry. According to Financial Supervisory Service on September 4th, Yuhan Corporation invested KRW 3.9 billion in the first half of the year and acquired an additional 3 million shares. Yuhan Corporation Headquarter Office buildingEstablished in 2018, Yuhan USA is a U.S.-based regional subsidiary of Yuhan Corporation and and is responsible for investing in potential biotech ventures, conducting global clinical trials, and delivering technology transfers. It is Yuhan Corporation's wholly-owned subsidiary and will serve as a bridgehead for global entry. Yuhan USA operates by having an East Coast office in Boston and a West Coast office in San Diego, United States. Boston is the hub for the world's biotech industry, and San Diego is emerging as a major biotech cluster. It has been two years since Yuhan Corporation invested in Yuhan USA in 2022. In the second quarter of 2022, Yuhan Corporation invested KRW 7.7 billion in Yuhan USA and acquired 6 million shares. Yuhan Corporation invested KRW 1.9 billion when it set up Yuhan USA in 2018. It invested an additional KRW 3.5 billion and KRW 3.6 billion in 2019 and 2020, respectively. In 2021, the company invested KRW 6.4 billion. Including this investment round, Yuhan Corporation has invested a total of KRW 27 billion over the past five years. Yuhan USA's strategy focuses on visiting companies, research centers, and universities in the United States to make direct investments in potential technology and new drug candidates. Its indirect investment strategy involves investing in biotech ventures in the United States or opening its fund to invite U.S.-based biotech ventures and investors. Most of the Yuhan Corporation's investment in Yuhan USA is invested in an investment fund run by 5AM Ventures, a Boston-based biotech venture capital firm. The strategy is continuously investing in overseas biotech funds and seeking new R&D opportunities. Furthermore, Yuhan USA participates in international conferences in the United States and presents clinical data of new drugs developed by Yuhan Corporation to increase chances for out-licensing. In 2020, Yuhan USA successfully out-licensed Yuhan Corporation's gastrointestinal medication. Yuhan Corporation signed an out-licensing agreement with Processa Pharmaceuticals in August 2020 for its ' YH12852,' a candidate for the treatment of functional intestinal disorder. The agreement included exclusive development, manufacturing, and commercialization rights for 'YH12852' worldwide, excluding South Korea. The total agreement amount is up to US$410.5 million (about KRW 500 billion). Yuhan Corporation has secured US$2 million worth of Processa Pharmaceuticals shares for a non-refundable upfront payment. Processa Pharmaceuticals is an R&D company established in Maryland, U.S., in 2016. Yuhan USA identified a potential out-licensing partner in the United States and successfully reached the final agreement with Processa Pharmaceuticals.
- Company
- Generic companies lastly challenge Lixiana patent
- by Kim, Jin-Gu Sep 04, 2024 05:48am
- Pic of Lixiana Generic companies have been filing late patent challenges against Lixiana (edoxaban), the market leader in the direct-acting oral anticoagulants (DOACs) market. This is due to the imminent expiry of the product's formulation patent, which is 2 years away. The strategy of the patent challengers is to avoid the formulation patent and launch generics early upon the expiry of the product patent in November 2026. According to industry sources on the 3rd, Dongkwang Pharmaceutical recently filed a trial to confirm the passive scope of Lixiana's formulation patent against Daiichi Sankyo. Prior to Dongkwang Pharmaceutical, Theragen Etex also filed a challenge to avoid the same patent last month. The interesting fact is that a series of such challenges had ended in the 2020-2021 season. The challenge to the Lixiana formulation patent began in July 2018 when Boryung Pharmaceutical first filed a trial to avoid Lixiana’s patent. Hanmi Pharmaceutical, Chong Kun Dang, Samjin Pharm, Kolmar Korea, Kolmar Pharma, HK. Inno.N, Hutecs Korea followed to receive trial decisions for the same patent. The companies won the first trial after May 2020. In 2021, Dong-A ST and Shinnil Pharmaceutical filed for the same judgment and won the first trial. The original manufacturer of Lixiana, dropped its appeal, and the first-instance victory was finalized as a ruling. This ended the patent challenge, with 10 generic companies avoiding Lixiana's formulation patent once and for all. Now, more than 3 years later, the challenge has resumed with Theragen Etex, Dongkwang Pharmaceutical filing the trials. The analysis is that the companies made the move as the expiry of Lixiana's product patent is now just 2 years away. There are 2 Lixiana patents listed on the MFDS’s green list: a product patent that expires in November 2026 and a formulation patent that expires in August 2028. Generic companies plan to avoid the formulation patent and launch generics of Lixiana early to coincide with the expiration of the product patent. If the companies that won the first trial won the invalidation trial, the patent itself would have been invalidated, rendering no need for latecomers to file separate challenges. However, since the previous companies won the passive scope confirmation trial rather than the invalidation trial, the latecomers must also file individual challenges. Of course, as other generic companies have already won, the chances of success for the latecomers are high. Quarterly DOAC prescriptions (Lixiana, Eliquis, Xarelto, Pradaxa) Industry insiders raised the possibility of additional patent challenges rising in the future due to Lixiana’s long-term lead in the DOAC market with prescription sales of more than KRW 100 billion per year. According to pharmaceutical market research institution UBIST, Lixiana’s prescription sales were KRW 105.3 billion last year. That is up 9% from the KRW 96.7 billion in 2022. In the first half of this year alone, the drug generated KRW 55.7 billion in prescription sales. Lixiana first became the market leader in 2019 and has maintained its lead ever since. The company attributed the rise in prescription sales to the copromotion synergy with Daewoong Pharmaceutical. Moreover, the gap with the second-ranked drug has been widening upon the expiration of the substance patents of its rivals Xarelto (rivaroxaban) and Eliquis (apixaban).
- Policy
- Alvogen voluntarily recalls Comtan Tab due to impurities
- by Lee, Hye-Kyung Sep 03, 2024 05:53am
- Single-agent entacapones, which are used for Parkinson's syndrome, are being recalled due to the detection of excess impurities. The issue of drug impurities continues to arise after MFDS has added nitrosamine impurity testing as a quality control test item to strengthen the management of nitrosamine impurities. On March 30, MFDS announced the recall of Alvogen Korea's Comtan Tab 200mg (entacapone) due to the detection of excess NDEA in the post-market stability test. In April, following the company's report that N-nitrosodiethylamine (NDEA) impurities were detected in its single agent entacapone, the MFDS began reviewing safety measures, including setting necessary temporary permissible standards based on the submitted test and inspection results. The MFD introduced the Carcinogenic Potency Categorization Approach (CPCA), which predicts carcinogenic potential based on the structure-activity correlation of molecules, to set standards for nitrosamine impurities as introduced by the European EMA and the U.S. FDA, and updated the daily intake allowance for nitrosamine impurities in Korea based on the standard-setting method. However, in the case of medicines with medical necessity or supply interruption (shortage), a temporary distribution allowance is applied for a certain period of time to address the supply and demand situation. The item being recalled this time is Comtan Tab 200mg with the lot number (expiration date) '2169627 (2026-07-30).’ Currently, there are only 2 items licensed in Korea as single-agent entacapone: Comtan Tab 200 mg and Myungin Entacapone Tab 200mg by Myung In Pharmaceutical. Single-agent entacapone is indicated as an adjunct to levodopa-dopa decarboxylase inhibitors in patients with Parkinson's syndrome whose symptoms do not improve with standard levodopa-dopa decarboxylase inhibitors therapy.
- Company
- Pharma companies jump into developing 'TPD' for cancer
- by Son, Hyung-Min Sep 03, 2024 05:53am
- The global and Korean pharmaceutical industries are focusing on securing Targeted Protein Degradation (TPD) technology, which has emerged following the success of Antibody-Drug Conjugates (ADCs). Recently, major global pharmaceutical companies such as Pfizer, Novartis, and Eli Lilly have successfully acquired TPD technologies, marking TPD as a new anti-cancer drug development strategy, following targeted therapies, immune checkpoint inhibitors, and ADCs. Korean pharmaceutical and biotech industries are also exploring the potential of TPD drug development and have achieved successful technology transfers. According to industry sources on September 3rd, several Korean biopharmaceutical companies, including Yuhan Pharmaceutical, SK Biopharmaceuticals, Daewoong Pharmaceutical, Samjin Pharmaceutical, and Orum Therapeutics, have jumped into developing novel TPD drugs. TPD drugs are the next-generation new drug candidate that can use an intracellular protein degradation system to degrade protein of interest specifically. Unlike conventional small-molecule targeted drugs that inhibit protein function, novel TPD drugs offer superior therapeutic effects and avoid tolerance by directly degrading and eliminating disease-causing proteins. TPD drugs can target over 80% of disease-causing proteins that conventional small-molecule drugs could not modulate. The mechanism of the TPD technology, previously referred to as PROTAC (source=KRICT). SK Biopharmaceuticals has identified TPD as a promising future field and is advancing its development as a follow-up to its epilepsy treatment, Xcopri. Last year, the company invested KRW 62 billion to acquire Proteovant, securing TPD technology. Founded in March 2020 in the U.S., Proteovant is a biotech venture with global-level technology in the TPD field and molecular glue technology. Yuhan Pharmaceutical is also eyeing the opportunity to develop TPD drugs as a follow-up to its non-small cell lung cancer treatment (NSCLC), Leclaza. The company acquired the prostate cancer drug candidate 'UBX-103' in July from Ubix Therapeutics. As a result, Yuhan Pharmaceutical has secured the lead for clinical trials and exclusive rights for the development and commercialization of UBX-103. The recently acquired 'UBX-103' by Yuhan Pharmaceutical is a novel prostate cancer drug candidate based on TPD technology. UBX-103 works by degrading the androgen receptor, overexpressed or hyperactivated in prostate cancer patients. In the non-clinical studies, UBX-103 showed ten times superior androgen receptor degradation and suppression of prostate cancer cell proliferation in wild type and mutant compared to 'ARV-110' of Arvinas, a U.S.-based company. In a castration-resistant prostate cancer mouse model, the drug showed three times more anti-cancer efficacy than ARV-110. Orum Therapeutics is proving its R&D capacity by successfully out-licensing TPD platform to global pharmaceutical companies. In July last year, the company signed an out-licensing agreement with the U.S.-based biotechnology company Vertex Pharmaceuticals for its TPD. Vertex Pharmaceuticals is a company that developed a CRISPR/Cas9 gene-edited therapy, exa-cel. Utilizing Orum Therapeutics' Dual-Precision TPD (TPD2), Vertex Pharmaceuticals plans to discover 'conditioning agents,' which are used to wash bone marrow before injecting patients with gene editing products. TPD, provided by Orum Therapeutics, is a technology that specifically degrades target proteins. Daewoong Pharmaceutical and Samjin Pharmaceutical have signed a strategic business agreement with the Korean TPD discovery company Pin Therapeutics to develop novel drugs. Pin Therapeutics is a novel drug discovery company established in 2017 that conducts global R&D by collaborating with 'PinUS,' a wholly-owned subsidiary in the United States. Global pharmaceutical companies proactively conduct novel TPD drugs Global pharmaceutical companies are also proactively developing novel TPD drugs. AstraZeneca has signed an out-licensing deal with the U.S.-based PineTree Therapeutics for exclusive sales and global rights. PineTree Therapeutics is a company established in 2019 in Boston, U.S., specializing in the development of novel drugs. PineTree Therapeutics' EGFR degrader candidate was developed using its proprietary multi-antibody platform, 'AbRaptor.' Based on the research, this candidate demonstrated anti-tumor activity when used in tumors resistant to drugs such as tyrosine kinase inhibitor (TKI). AstraZeneca has the EGFR drugs Tagrisso and Iressa for the treatment of non-small cell lung cancer (NSCLC). Utilizing the TPD technology, the company plans to develop follow-up drugs for Tagrisso and Iressa. Global pharmaceutical companies like Pfizer and Novartis have invested over KRW 1 trillion in Arvinas' TPD pipeline development. The U.S.-based company Arvinas is a leader in the TPD field. Arvinas' platform PROTAC was previously referred to as TPD technology. The company is the only company in the world to own a proprietary novel TPD candidate that has entered the Phase 2 trial. In 2021, Arvinas signed an out-licensing deal with Pfizer for its novel TPD drug, 'ARV-471,' for breast cancer treatment. It also transferred androgen receptor degrader 'ARV-766' to Novartis. With the agreement, Novartis will be responsible for the global clinical trial development and commercialization of ARV-766. Last year, Arvinas announced ARV-766's interim data from dose escalation research. Based on the clinical results, the drug demonstrated a 50% reduction of prostate-specific antibody (PSA) in 41% of patients with mutations in the ligand-binding domain in the androgen receptor. Novartis will aim to commercialize ARV-766 as a prostate cancer treatment and enter the later stage of clinical trials. Additionally, various global companies like Novo Nordisk, Astellas, and Eli Lilly have jumped into this field by investing in companies developing novel TPD drugs.
