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- 2026-05-03 11:29:40
- Company
- Commercialization of global RSV vaccines in progress in KOR
- by Son, Hyung-Min Jul 31, 2024 05:52am
- A global respiratory syncytial virus (RSV) vaccine has entered late-stage clinical trials for the first time in Korea, testing its potential for commercialization. Pfizer recently received approval to initiate a Phase III clinical trial in Korea to evaluate the immunogenicity of its RSV vaccine. Moderna is applying for Japanese approval of its RSV vaccine, which was approved in the U.S. in May, and making its way into Asian countries. Among domestic biotech companies, EuBiologics has entered Phase I clinical trials in Korea. RSV is a virus that causes pneumonia and bronchitis. The virus can affect a person of any age, but the infection rate is particularly high in infants and young children. It is the leading cause of hospitalization in infants and young children, and 90% of infants worldwide are infected with RSV before the age of 2. When infected, RSV causes symptoms similar to the common cold, but some infants and children may experience a more severe course, leading to lower respiratory tract illnesses such as pneumonia and bronchiolitis. According to industry sources on the 30th, the Ministry of Food and Drug Safety approved the Phase III IND for the RSV vaccine 'PF-06928316' submitted by Pfizer on the 26th. The trial will be conducted at 16 institutions, including Samsung Medical Center, Severance Hospital, and Seoul St. Mary's Hospital, from October this year to December next year. In the trial, Pfizer will evaluate the safety, tolerability, and immunogenicity of the RSV vaccine in 360 older adults. The primary endpoints will be local reactions (redness, swelling, and pain at the injection site) and systemic events (fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain), based on which the company will evaluate the adverse events and tolerability of PF-06928316. Participants will be randomized in a 2:1 ratio to PF-06928316 or placebo. PfizerPfizer’s RSV vaccine was approved in the U.S. last year and launched under the brand name Abrysvo. Abrysvo is indicated for adults 60 years of age and older, infants 6 months of age and younger, and pregnant women at less than 37 weeks gestation. Recently, Pfizer confirmed the immunogenicity of Abrysvo in adults aged 18 to 59 years, raising the possibility of its indication expansion. Abrysvo demonstrated non-inferior neutralization responses in 681 adults aged 18 to 59 years with certain chronic diseases and 200 immunocompromised adults compared to that identified in the original clinical trial that evaluated the vaccine in older adults. Participants also achieved at least a four-fold increase in serum neutralizing titers following receipt of Abrysvo compared to pre-vaccination. These results support the potential for Abrysvo’s expanded indication. It also opened the door for Pfizer to enter clinical trials in Korea to evaluate the immunogenicity of the RSV vaccine in all ages. Moderna receives approval in the U.S. and seeks to enter the Asian market…EuBiologics starts clinical trial in Korea The RSV vaccine market is currently in a three-way battle between Abrysvo, GSK’s ‘Arexvy,’ and Moderna’s mRNA-1345, with Moderna conducting a clinical trial to develop a follow-on drug. Among the companies, Moderna has applied for mRNA-1345’s approval in Japan and is seeking to enter the Asian market. Moderna submitted an application for mRNA-1345 to Japan's Ministry of Health, Labour and Welfare in May. mRNA-1345 was approved in the U.S. in May and was developed to prevent RSV in adults aged 60 and older. The application is based on the interim analysis results of the Phase III ConquerRSV that demonstrated immunogenicity and tolerability of mRNA-1345. The trial was conducted in 22 countries, including Japan. The ConquerRSV trial was a randomized, double-blind, placebo-controlled study that enrolled approximately 37,000 adults aged 60 years and older in 22 countries, including the United States. The interim analysis was based on two definitions of RSV lower respiratory tract disease (RSV-LRTD), defined as two or more symptoms or three or more disease symptoms. Results showed that in RSV-LRTD defined as two or more symptoms, mRNA-1345 met all primary endpoints, including demonstrating 83.7% vaccine efficacy. Adverse events with mRNA-1345 were mild to moderate, with the most commonly reported adverse events in the mRNA-1345 arm being injection site pain, fatigue, headache, myalgia, and arthralgia. In addition to the U.S. and Japan, Moderna plans to file for approval of mRNA-1345 in the European Union (EU) and other countries. In Korea, EuBiologics has entered clinical trials. The euRSV vaccine being developed by EuBiologics has recently been administered to 3 RSV patients at Korea University Guro Hospital. Patients were randomized to placebo, low-dose EuRSV, and high-dose EuRSV to evaluate the vaccine’s tolerability and safety. EuRSV is a recombinant protein subunit vaccine that combines the virus’s F-protein antigen with an immune booster. In 2017, Eubiologics in-licensed the immune booster EuIMT from the Korea Institute of Science and Technology. EuBiologics aims to enter global Phase 2/3 trials through its U.S. subsidiary, Eupop Life Sciences, which holds the marketing rights for EuRSV in the North American and European markets. In addition, SK Bioscience is also developing an mRNA-based RSV vaccine candidate like that being developed by Moderna. SK Bioscience began RSV vaccine development in 2018 with the aim to commercialize it by 2029 but is still in the basic research stage.
- Policy
- Approval of abortion drugs at a halt in KOR
- by Lee, Jeong-Hwan Jul 31, 2024 05:52am
- The Ministry of Food and Drug Safety has gained attention for stating that the Criminal Code and the Mother and Child Health Act must be amended before the approval of abortion drugs in Korea. The process of gaining marketing authorization for abortion drugs that the pharmaceutical companies applied for has been at a halt for 4 years, as follow-up legislation has not been enacted since the constitutionality of abortion was ruled unconstitutional. On the 29th, the Ministry of Food and Drug Safety responded so to a point raised by Representative Sun-min Kim of the National Assembly's Health and Welfare Committee regarding the domestic approval of abortion drugs. Kim raised the need for expedited approval of abortion drugs, questioning why the abortion drug has not yet been approved despite repeated applications submitted in 2021 and 2023. Hyundai Pharm applied for the marketing authorization of Mifegymiso in 2021 after signing an exclusive marketing and distribution agreement for its supply in Korea with the UK-based Linepharma International. However, the company voluntarily withdrew its application upon the MFDS’s data supplement request. The company then reapplied for the license last year (2023) and received another data supplementation request. Mifegymiso is a combination pack that contains 1 200mg mifepristone tablet and 4 misoprostol 200ug tablets. The drug inhibits the action of progesterone, the progestational hormone that sustains pregnancy, while misoprostol works to contract the uterus. It is only indicated for use in the first trimester of pregnancy, up to 9 weeks, and is typically prescribed as one tablet of mifepristone followed by 4 tablets of misoprostol 36-49 hours later. The MFDS’s position is that the Criminal Code and the Mother and Child Health Act must be amended before Mifegymiso, which the company has reapplied for approval, can be approved in Korea. The logic is that the abortion period should be established first so that a risk management plan can be submitted for the approval of abortion drugs like Mifegymiso. "Currently, there are permit data that can only be submitted after the amendment of the Criminal Code and the Mother and Child Health Act, which is why the review process has been temporarily suspended upon mutual recognition of the applicant and the MFDS,” said an MFDS official. "If the relevant laws are amended and the applicant submits data accordingly, we plan to resume the review without delay and decide whether to approve or reject the application.” Meanwhile, when the amendments will be made to the Criminal Code and Mother and Child Health Act remains unclear. In April 2019, the Constitutional Court ruled the criminal offense of abortion (termination of pregnancy) unconstitutional, citing respect for women's right to bodily self-determination. As of January 1, 2021, abortion was effectively legalized. The Constitutional Court ordered the National Assembly to come up with alternative legislation to reflect the decision, but 4 years have passed without such legislation being enacted. In the 21st National Assembly, 7 bills to abolish the abortion law were introduced, including amendments to the Criminal Code and the Mother and Child Health Act, but were never properly discussed until the end of the 21st NA period.
- Company
- Competition rises in 1st-line urothelial cell carcinoma mkt
- by Eo, Yun-Ho Jul 31, 2024 05:51am
- The battle for the first-line treatment market for urothelial cell carcinoma (bladder cancer) is heating up amongst anticancer drugs. In addition to the PD-L1 immuno-oncology drug Bavencio (avelumab), which is already being reimbursed in Korea, the PD-1 immuno-oncology drug Opdivo (nivolumab) in combination with cisplatin and gemcitabine, and the antibody-drug conjugate (ADC) Padcev (enfortumab vedotin) in combination with the PD-1 immuno-oncology drug Keytruda (pembrolizumab) have entered the market one after another. The Opdivo and the ‘Padcev+Keytruda’ combination have garnered particular attention due to their recent almost simultaneous indication expansions. It remains to be seen whether these drugs will be successful in gaining reimbursement in Korea. The approval of Opdivo was based on the results of the Phase III CheckMate-901 study, which compared patients receiving either nivolumab in combination with cisplatin and gemcitabine (up to 6 cycles) followed by nivolumab alone for up to two years or cisplatin and gemcitabine (up to 6 cycles). Key results showed a statistically significant improvement in the study’s primary efficacy endpoint, overall survival (OS), and progression-free survival (PFS) as assessed by a blinded independent central review committee (BICR) in the Opdivo combination arm. The safety profile of the Opdivo regimen observed in the study was consistent with previously reported studies, with no new safety signals identified. The efficacy of the Padcev+Keytruda combination was demonstrated in the Phase III EV-302/KEYNOTE-A39 study. In the study, the primary endpoint, median progression-free survival (PFS) was 12.5 months in the Padcev+Keytruda arm, significantly higher compared with the 6.3 months in the chemotherapy arm. The secondary endpoint, median overall survival (OS), was 31.5 months, nearly doubling the 16.1 months observed in the control arm. In August 2023, Bavencio became the first immuno-oncology drug to receive reimbursement in Korea as a first-line maintenance treatment in adult patients with locally advanced or metastatic urothelial cell carcinoma whose disease has not progressed with first-line platinum-based chemotherapy.
- Company
- Clinical trials for K-pharma's new lung fibrosis drugs
- by Son, Hyung-Min Jul 31, 2024 05:51am
- Pharmaceutical and biotech companies in South Korea are developing new drugs for Idiopathic pulmonary fibrosis (IPF). BridgeBio's Bersiporocin has progressed to Phase 2 trials, and the company has recently completed registering patients for Phase 2 trials. Nextgen Bioscience received Phase 1 investigational new drug (IND) approval from the Ministry of Food and Drug Safety (MFDS) earlier this month and will begin assessing the potential of commercialization. Daewoong PharmaceuticalAccording to industry sources on July 31st, Daewoong Pharmaceutical received a recommendation from the second independent data monitoring committee (IDMC) meeting to continue clinical trials. At the first IDMC meeting in March and the second meeting, Bersiporocin's safety data presented no issues. IDMC comprises experts who independently monitor the safety of study participants and pharmaceutical efficacy during clinical stages. As an independent committee with objectivity, IDMC recommends sponsors regarding the trial's progress, study participant recruitment delays, clinical design changes, and discontinuance of clinical trials. Bersiporocin is a new drug candidate and a PRS inhibitor that provides anti-fibrotic effects to collagen synthesis. Bersiporocin's mechanism involves inhibiting the excessive synthesis of collagen, known as the cause of fibrosis. IPF is a form of interstitial pneumonia characterized by progressing pulmonary fibrosis. This disease has unmet needs because currently available treatments have limited treatment effects. Bersiporocin was evaluated for its safety and pharmacokinetic properties, including absorption, distribution, and metabolism, in a Phase 1 clinical trial involving 162 healthy adults in South Korea and Australia in 2022. The following year, Daewoong Pharmaceutical received approval for a multinational Phase 2 trial to assess the efficacy and safety of Bersiporocin in patients with idiopathic pulmonary fibrosis aged 40 and older. Currently, this trial involves patients either on approved treatments or have discontinued them. The Phase 2 trial is being conducted in 10 institutes in South Korea, including Asan Medical Center and Severance Hospital, and about 20 institutes in the United States. To date, this trial recruited 61 patients, and the total patient cap is 102. BridgeBio completes registering patients for Phase 2 trial…Nextgen enters clinical trial In addition to Daewoong Pharmaceutical, BridgeBio, Nextgen Bioscience, and iLeadBMS, Ildong Pharmaceutical's subsidiary, are conducting clinical trials for new drugs to treat IPF. BridgeBio has recently completed registering 120 patients for the Phase 2 trial of its new drug candidate, ‘BBT-877,’ for IPF. The Phase 2 trial is evaluating the efficacy, safety, and tolerability of BBT-877 compared to placebo in 120 patients with IPF. It is now being conducted in 50 institutes across South Korea, the United States, Australia, Poland, and Israel. BBT-877 is an innovative new drug candidate, selectively inhibiting the new targeted protein, autotaxin. Autotaxin is a protein known to bind receptors and is involved in pathologies of sclerosis and tumorigenesis. BridgeBio secured an exclusive global license of BBT-877 from LegoChem Biosciences (currently LigaChem Biosciences) in 2017. In May, BridgeBio received a recommendation from IDMC to continue its clinical trial. Based on data evaluating the efficacy and safety of BBT-877 in 75 study participants, no issue has been found regarding the drug's safety and effects. Earlier this month, Nextgen Bioscience received IND approval from the MFDS for its Phase 1 clinical trial of a new drug candidate, ‘NXC680.’ Designed to work by an anti-fibrotic mechanism, NXC680 selectively inhibits autotaxin, which is known to be involved in various fibrotic diseases. In January 2023, NXC680 received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA). Ildong Pharmaceutical's subsidiary, iLeadBMS, is developing new drugs in addition to Pirespa (pirfenidone), which can delay IPF symptoms. iLeadBMS's IL1512 works by targeting CXCR7, which promotes inflammation and fibrosis. Through this mechanism, IL1512 regulates the mechanism associated with the progression of liver fibrosis, such as fibroblast activation, organ recovery, and angiogenesis. In a preclinical study, IL1512 demonstrated improvements in bleomycin-induced skin fibrosis mouse model. Ildong Pharmaceutical is developing a generic medicine referencing Ofev (Nintedanib), previously released by Boehringer Ingelheim. Ofev is a targeted therapy with proven effects to delay IPF disease progression. Ofev data indicate that it can reduce lung function reduction by 50%. Il Dong Pharmaceutical has recently completed the biological equivalence testing of Ofev generic and is analyzing the data. Ildong Pharmaceutical plans to target the IPF market with Pirespa and its new drug, Ofev generic.
- Company
- Samsung Bioepis launches Stelara biosimilar Pyzchiva in EU
- by Hwang, Byung-woo Jul 30, 2024 05:52am
- Samsung Bioepis has launched Pyzchiva, its biosimilar version of Stelara (ustekinumab), in the European market. Pic of PyzchivaPyzchiva was approved in Europe and Korea in April and was launched into the Korean market as Epyztek. The drug was approved in the U.S. in June. The company’s marketing partner, Sandoz, will take charge of its sales in Europe. Samsung Bioepis signed a partnership agreement with Sandoz in September last year to sell Pyzchiva in North America and Europe Stelara is a treatment for autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis that was developed by Janssen. It posts annual global sales of approximately KRW 14 trillion (USD 10.858 billion). With the launch of Pyzchiva, Samsung Bioepis has now launched 8 biosimilars in Europe. In addition to the 3 tumor necrosis factor-alpha (TNF-α) inhibitors, Samsung Bioepis has expanded its autoimmune disease treatment portfolio in Europe by adding an interleukin inhibitor. "Our goal is to ensure that patients across Europe have access to life-changing medicines, and Pyzchiva marks an important milestone as one of the first ustekinumab biosimilars released in Europe," said Rebecca Guntern, Region President of Sandoz Europe. Meanwhile, Samsung Bioepis has been directly selling Epyztek in Korea. The company’s strategy was to strengthen its marketing capabilities and increase profitability by adding Epyztek to the list of autoimmune disease treatments it has been selling directly since March. According to the 'Drug Reimbursement List and Ceiling Price Table' as of July 1 by the Health Insurance Review and Assessment Service, Epyztek’s drug price was set at KRW 1,298,290 for the 45mg/0.5ml prefilled Inj. This is about 40% lower than the price of the original drug. Stelara’s price is also set to be reduced following the launch of the biosimilar, but Epyztek offers a price benefit even with the original drug’s price discount.
- Opinion
- [Reporter's View] Insight into reimb of high-priced drugs
- by Eo, Yun-Ho Jul 30, 2024 05:52am
- How should we consider the reimbursement coverage of 'preventive' drugs that are not used to treat disease or improve symptoms? This is not a new concept. Individuals have taken medicines for 'management' rather than treatment for chronic diseases. Medicines such as coagulants are primarily preventive care. However, it has become an issue as more high-priced drugs are on the market, expanding reimbursement coverage to anticancer drugs. Various new anticancer drugs are being studied to secure and add indication for use as pre- and post-operative adjuvant therapy. Numerous next-generation new drugs, including cancer immunotherapy, targeted cancer therapy, and antibody-drug conjugate (ADC), now have expanded indications for adjuvant therapies. In other words, there are plenty of indications. However, an issue arises with adjuvant therapy. The challenge is the price. As most people know, cancer can relapse even if initially diagnosed as fully recovered. Depending on different cancer types, the recurrence rate can be up to 80%. Prescribing anticancer drugs as adjuvant therapy and allowing those to be reimbursed burdens the Ministry of Health and Welfare (MOHW). It is uncommon for adjuvant therapy to be reimbursed in South Korea. Furthermore, academics also pay attention to the benefits of adjuvant therapy. Guidelines by notable international academic organizations have started to include adjuvant therapy and assign the highest grade. The Korean market must stop looking the other way. Relevant parties must carefully assess the necessity of adjuvant therapy and consider its benefits rather than viewing it as an unwarranted 'burden.' Administering adjuvant therapy to relapsed patients can be less cost-effective. The number of pharmaceuticals acquiring indications for adjuvant therapy and maintenance therapy is increasing. Rather than considering only the loss and benefits, pharmaceutical characteristics and patients' circumstances must be considered. Efforts from all relevant parties are required to reach an agreement that considers the National Health Insurance system and the pharmaceutical industry's stances.
- Company
- First patient dosing with Pluvicto imminent in Korea
- by Moon, sunh-ho Jul 30, 2024 05:52am
- Novartis Korea's prostate cancer drug Pluvicto, which has been in the spotlight since its approval by the Ministry of Food and Drug Safety, is gaining further attention as the company prepares to administer the first dose to patients in Korea. Pluvicto is a blockbuster drug that generated more than KRW 1 trillion in global sales last year and is considered to have ushered in the era of so-called ‘radiopharmaceutical missiles’ in oncology. # Unlike Bayer's Xofigo, which was licensed as a radioactive therapeutic agent in 2014 but was ignored by the market, Pluvicto opened a new era making noteworthy performance. As a result, global pharmaceutical companies are rushing to develop radiopharmaceuticals after witnessing the success, intensifying competition among domestic pharmaceutical and biotech companies. According to the medical and pharmaceutical industry on the 27th, the first patient is expected to be treated at one of the largest general hospitals in Korea in late August, after the Ministry of Food and Drug Safety’s approval of Novartis Korea's prostate cancer drug Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in late May. Pluvicto is a radioligand therapy that binds the radioactive isotope lutetium (177Lu) to prostate-specific membrane antigen (PSMA), which is overexpressed in prostate cancer, to kill cancer cells. The treatment was acquired by Novartis through its acquisition of US-based Endocyte in 2018. Radioligands are therapeutic agents that combine a therapeutic radioisotope with a ligand (which targets specific cancer cells). When the radioligand binds to the target cell, it releases the therapeutic radioisotope, inhibiting cancer cell proliferation. Its May approval was based on the Phase III VISION trial. The trial evaluated the efficacy and safety of Pluvicto versus standard-of-care monotherapy in 831 patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). Results showed that the the primary endpoint of radiologic progression-free survival (rPFS) was 8.7 months in the Pluvicto arm, which was longer compared to 3.4 months in the control arm. Median overall survival (OS) was 15.3 months in the Pluvicto arm and 11.3 months in the control arm. The risk of radiographic progression or death was reduced by 60% with the use of Pluvicto. Since the drug was approved by the MFDS, Novartis Korea has been working to start treating patients at the largest hospitals in Korea. In order for medical institutions to introduce the radiopharmaceutical Pluvicto, the institutions need to have a PSMA PET-CT dedicated to prostate cancer and have a separate room for dispensing, quality control, and patient administration of radioactive therapeutic agents. Currently, 15 medical institutions nationwide, including the largest hospitals in Korea, are equipped with PSMA PET-CT for testing. Novartis is currently in discussions with 11 of these medical institutions, including Asan Medical Center in Seoul, to provide Pluvicto to prostate cancer patients. With the first patient expected to be treated without reimbursement as early as August, Novartis Korea is considering introducing a patient program to address the high price of the drug. For reference, the recommended dose of Pluvicto is 7.4 GBq (200 mCi), administered intravenously up to 6 times every 6 weeks (±1 week), and it is expected that tens of millions of won will be spent per dose without reimbursement in clinical sites. "From the HCP’s point of view, we believe the introduction of Pluvicto will have a positive impact in that it increases the number of weapons available for prostate cancer, and is a proven treatment with no significant side effects," said Dr. In-Keun Park, Professor of Oncology at Asan Medical Center. "The problem is that it is expensive and there are only a limited number of institutions that can perform PSMA PET-CT, rendering its administration equally limited." "Because it is a radioactive therapeutic agent, it requires a separate space for its administration rather than a general hospital room. Like Kymriah, Pluvicto is also produced through pre-orders," said a representative from Novartis Korea, "So it takes a considerable process to produce the drug in Europe and deliver it to patients in Korea." "We are reviewing the possibility of introducing a patient program. However, due to the nature of radioactive therapeutic agents, it is quite expensive. This is because it utilizes lutetium, a radioactive isotope," the representative added, "We are also discussing the possibility of applying for insurance reimbursement." With the use of Pluvicto nearing on-site, the competition among domestic pharmaceutical and biotech companies to develop radiopharmaceuticals is also heating up. Currently, FutureChem is at the forefront in the area. In mid-May, FutureChem began dosing its first patient in the U.S. for a Phase IIa clinical trial of FC705, a prostate cancer drug for castration-resistant metastatic patients. FC705 is a radiopharmaceutical that targets PSMA, which is overexpressed on the surface of prostate cancer cells. It kills cancer cells by introducing a therapeutic isotope into a peptide that binds to the PSMA protein. In a Phase I clinical trial, an objective response rate (ORR) and disease control rate (DCR) were confirmed in all patients who were administered FC705. In addition to the U.S. clinical trial, FutureChem is also conducting Phase II in Korea, including at Seoul St. Mary's Hospital, and is reportedly discussing technology transfer negotiations with China. In addition, AbTis, a subsidiary of Dong-A ST, is working with CellBion to develop a new radiopharmaceutical. The two companies signed a joint development agreement last month and will utilize AbTis’ linker platform technology AbClick and CellBion's radiopharmaceutical lab linker technology to develop a new Antibody-Radionuclide Conjugate (ARC) drug targeting stomach and pancreatic cancer. Recently, SK Biopharmaceuticalsentered into a license-in technology transfer agreement with Full-Life Technologies to acquire global development and commercialization rights to FL-091, a radiopharmaceutical candidate targeting neurotensin receptor 1 (NTSR1), from Full-Life Technologies. FL-091 small-molecule radioligand vector designed to deliver actinium-225 (225Ac), a next-generation radioisotope capable of killing cancer cells by selectively binding to NTSR1, a receptor protein, which is selectively overexpressed in various types of solid tumors, including colorectal cancer, prostate cancer, and pancreatic cancer. SK Biopharm has been discussing introducing radiopharmaceuticals into its pipeline since last year as the next step after its epilepsy drug cenobamate (U.S. brand name: Xcopri). The company acquired global-level Targeted Protein Degradation (TPD) technology through the acquisition of ProteoVant Sciences last year. The TPD technology seeks to overcome the limitations of existing therapeutics by degrading and removing target proteins and solving the causes of diseases. "This license agreement is the most concrete achievement we have made since the announcement of our entry into the field of radiopharmaceutical therapeutics last year," said Dong-hoon Lee, CEO of SK Biopharmaceuticals. "We plan to unveil a more specific business plan for the entire radiopharmaceutical business this year and accelerate clinical development and commercialization."
- Opinion
- [Reporter's View] Pharmas rethink bio venture investments
- by Lee, Seok-Jun Jul 30, 2024 05:51am
- Multiple pharmaceutical companies have made significant investments in promising bio ventures, spending a substantial amount to acquire shares. Some have become the largest shareholder, and those holding over 5% of the share are involved in the management. Through the investment, companies anticipate sharing R&D results in the future. However, such expectations pose challenges. First, ventures require regular funding. Venture pipelines are mostly in early clinical stages. They must secure costs for the later phase of clinical trials. However, it is uncommon for ventures to generate sales regularly. As they advance to later phases of clinical trials, they may quickly need funds. Listed ventures depend on exterior funds, such as recapitalization and convertible bonds (CB). This process works by issuing new stock to raise funds. Pharmaceutical companies investing in ventures want to secure liquidity through clinical trials. However, the percentage of shares owned by pharmaceutical companies decreases with new stocks. Some companies have complained that unnotified funding disrupts their business plans. Pharmaceutical company A owner complained, "We have invested in Venture A by acquiring over 5%. However, our stock share reduced to 3% after Venture A received multiple funding. Frequent funding of Venture A caused a market liquidation signal, leading to decreased stock prices. Unnotified funding has resulted in a setback for our business plan. We are reconsidering whether to hold the share." Moreover, pharmaceutical companies are also concerned about the gap between the venture's plan for clinical trials before going public and the present. In this case, a decrease in stock prices could result in a reduction in stock share value. In the fifth year of listing, most pipelines of TiumBio did not reach the originally planned clinical stage or achieve technology transfers. Their accumulated net loss is over KRW 100 billion. Before being listed on the KOSDAQ at the end of 2019, TiumBio expected to turn a net profit from 2022, anticipating generating a net profit of KRW 54.1 billion by 2023. However, the company has been in deficit. The company also expected to raise operating revenue of KRW 81.5 billion in 2023 but realized operating revenue amounted to KRW 4.9 billion instead. During this time, TiumBio's market capitalism plunged by one-fourth over three years and a half. Consequently, pharmaceutical companies are withdrawing their venture investment shares because of frequent funding and differences in their investment plan compared to the venture's listing. Companies like D and W have retrieved their principal, leaving only the rest of the shares, and another company sold the entire second-quarter stock. Of course, pharmaceutical companies invest in ventures at high-risk and high return because they have invested in the potential R&D of those ventures. However, ventures must also take some responsibility. Ventures must not defend that frequent funding is prerequisite for clinical trials. They must notify all investment partners before raising funds. Additionally, ventures must explain the differences between expected gain and realized loss. They should not argue that delays in earning profits are anticipated outcomes of clinical studies. Many venture companies receive frequent funding, and their outcomes are different from their initial plan before going public. Pharmaceutical companies that have invested in these venture companies are reconsidering their investments. If this trend continues, it may disrupt the virtuous circle of investment between pharmaceutical companies and venture technology.
- Policy
- GSK receives administrative disposition in KOR
- by Lee, Hye-Kyung Jul 30, 2024 05:51am
- The global pharmaceutical company GlaxoSmithKline (GSK) has received administrative dispositions for failing to report changes to the specifications of the main ingredient of its active pharmaceutical ingredient and for issues relating to the drug containers. The Ministry of Food and Drug Safety recently imposed a fine of KRW 52.2 million in substitution of the 15-day suspension on the sale of ‘Duac Gel 5%,’ a 6-month import suspension on ‘Flixoteide Junior Evohaler 50 micrograms,’ and a 6-month import suspension on ‘Seretide 100-250-500 Diskus.’ Duac Gel is a gel-type mild-to-moderate treatment for acne that contains clindamycin phosphate and benzoyl peroxide. It is prescribed as an alternative that can alleviate concerns about the development of resistance that may arise from the use of antibiotics. However, an investigation by the MFDS found that the direct containers of the drug were imported and sold with the lot numbers and expiration dates switched with each other. As a result, the MFDS announced it will suspend the sales of Duac Gel 5% from August 1. Also, 1 item, which was suspended for six months, and 3 items, for which the company decided to pay fines instead of the suspension, were found to have failed to report changes in the specifications of the active pharmaceutical ingredient in the drug substance. The company will pay a fine of KRW 52.2 million for 3 items - Seretide 100 Diskus, Seretide 250 Diskus, and Seretide 500 Diskus - imposed in place of the 6-month suspension. Sales of Flixoteide Junior Evohaler 50 micrograms, a preventive treatment for asthma, are suspended for 6 months from August 1 to January 31, 2025.
- Company
- Pfizer's MM drug Elerexfio seeks reimb in KOR
- by Eo, Yun-Ho Jul 29, 2024 05:48am
- Pfizer is attempting reimbursement listing of its new multiple myeloma drug ‘Elerexfio’ in Korea. According to industry sources, Pfizer Korea recently submitted a reimbursement application for its relapsed-refractory multiple myeloma (RRMM) treatment q (elranatamab). The company promptly started its listing process after receiving approval on May 30. Elerexfio previously received approval as the fourth drug to be designated as a Global Innovative products on Fast Track (GIFT) by the MFDS. GIFT is an accelerated review support system operated by the MFDS to promptly introduce highly innovative medicines, such as treatments for life-threatening or serious diseases, to the market and patients. Elerexfio is a subcutaneously delivered B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody (BsAb) immunotherapy used to treat patients with relapsed or refractory multiple myeloma (RRMM). BCMA is commonly expressed in multiple myeloma patients, selectively expressed in plasma cells, and overexpressed in myeloma cells. Elerexfio binds to BCMA on myeloma cells and CD3 on T-cells to enhance the immune response. The treatment is administered weekly from Week 2 through Week 24 of treatment following a step-up dosing schedule, with patients who achieve a response after at least 24 weeks of treatment switching to a 2-week interval beginning at Week 25. It is available in a single-dose vial for immediate outpatient administration and is administered by subcutaneous injection only. The approval was based on the global Phase II MagnetisMM-3 study, which included 123 patients who had never received a BCMA-targeted therapy. In patients with multiple myeloma who have already received at least 3 treatment regimens (including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody) and have no prior treatment experience with a BCMA-targeted therapy, Elerexfio achieved a primary endpoint objective response rate (ORR) of 61.0% in patients, with 56.1% of responders achieving a very good partial response (VGPR) or better. In responders, the median time to response (TTR) was 1.2 months, and the median time to complete response (CR) was 6.1 months. In addition, the probability of maintaining ≥CR at 9 months was 89.0%, with a progression-free survival of 50.9% at 15 months. Meanwhile, according to the World Health Organization's ‘Global Cancer Observatory’ report that was published in 2022, approximately 187,000 new cases of multiple myeloma were newly diagnosed worldwide. Multiple myeloma is the second most common type of blood cancer, with a 5-year relative survival rate of 50.1% in Korea in 2021. According to the annual report of the National Cancer Registry, 2018 cases were diagnosed in Korea in 2021.
