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- 2026-05-07 23:25:57
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- SK Bioscience declares its vision
- by Kim, Jin-Gu Apr 13, 2023 05:43am
- SK Bioscience announced on the 12th that it held a vision proclamation ceremony at Andong L House on the 11th and pledged to become a 'global bio hub' through 'One Goal, One Team'. About 450 executives and employees attended the vision proclamation ceremony, including Ahn Jae-yong, CEO of SK Bioscience, Kim Hoon, CEO of Global R&BD, and Lee Sang-gyun, plant manager (vice president) of L House. The vision proclamation ceremony consists of a time to look back on the achievements and major milestones that L House has achieved during the COVID-19 pandemic and to share future strategies and goals at the time of transition to the endemic era. SK Bioscience shared the future strategy of 'SKBS 3.0', which consists of specific action tasks and action plans to grow into a global company in the endemic era, and a 'digital establishment plan'. In addition, to achieve the One Goal of 'Global Innovative Partner of Vaccine and Biotech', the members of L House were asked to join forces as one team in the future. In particular, the acquisition of cGMP (Current Good Manufacturing Practice) from the U.S. Food and Drug Administration (FDA) was selected as a key task for L House to achieve SK Bioscience's vision. Along with this, SK Bioscience plans to solidify its position as a global vaccine production hub by expanding facilities of about 1,067,616 sqft in L House. In addition, it plans to build a global top-tier R&D network through the 325.7 billion won Global R&PD Center being established in Songdo, Incheon with the goal of completion in 2025. Ahn Jae-yong, CEO of SK Bioscience, said, "Today's vision proclamation ceremony is a place where the members of House L announce their will to achieve 'One Goal' by gathering strength through the 'One Team' culture." We will secure a vaccine portfolio and promote sustainable growth.” Lee Sang-gyun, Plant Manager, said, “SK bioscience has been able to stand at the center of the response to the COVID-19 pandemic over the past three years because of the valuable efforts of L House members.” I am grateful to the staff," he said.
- Company
- LSK's contracts for early-phase clinical trials increase
- by Lee, Tak-Sun Apr 12, 2023 05:54am
- After analyzing Korea’s clinical trial trend through the number of its contracted research, LSK Global Pharma Services Co., Ltd. (LSK Global PS) announced that the number of early-phase clinical trials increased significantly recently. As of March 2023, the company’s number of contracted clinical research was 1,503, including 164 global clinical trials and 1,339 domestic clinical trials. Since its establishment in 2000, the company’s number of contracted research cases reached 1,000 in 2018 and then increased by 50% in 5 years thereafter. By research type, the number of Phase III clinical trials was the highest at 372 cases, and the rate of increase or decrease in the trials compared to 2018 showed that early phase trials such as Phase II clinical trials (▲ 62%) and Phase I clinical trials (▲ 49%) increased the most. A similar trend can be observed when dividing the domestic clinical trial approval status by phases. In the past, late-stage clinical trials were more actively conducted than early-stage clinical trials in Korea. However, with various domestic clinical trials being conducted by CROs and accumulated experience, early clinical trials are now being actively conducted, and related infrastructure has also been established. To accommodate the increase in demand, in 2021, LSK Global PS explained that it has been providing differentiated services by operating a team dedicated to early-phase trials to respond to the increasing demand for early-phase clinical trials. This also aligns with the global drug development trend. Anticancer drugs are still the most actively researched area in new drug development due to high unmet demand, and 10 to 20 new drugs are approved by the US FDA every year in the area. In Korea, R&D investment and recruitment of research personnel in the field of anticancer drugs is being actively carried out recently. Young-Jack Lee, CEO of LSK Global PS, said, “Unlike treatments for other diseases that are highly prevalent, there are many factors to consider when developing an anti-cancer drug, such as disease complexity, tumor heterogeneity, toxicity, and resistance, and require huge time and monetary investments. LSK Global PS offers medical consulting throughout clinical trials for anticancer drugs from setting target patient groups, study design, and efficacy endpoint suggestions to help establish and conduct strategic clinical trials.” A total of 129 clinical trials (54 global, 75 domestic) related to Investigational New Drug Applications (IND) that are conducted to receive approval from regulatory authorities were found to be in progress. By clinical stage, Phase I and Phase II clinical trials, and by disease group, anticancer drugs increased the most, showing a similar trend with the change in the total number of contracted clinical research. In addition to the continuous rise in the number of contracted clinical research related to new drug development, marked growth has also been observed in the fields of digital therapeutics and medical devices. Compared to 2018, the number of contract clinical research cases for medical devices had increased around threefold, 10 of which trials are related to digital therapeutics. LSK Global PS newly established a medical device clinical team in January of last year to provide more specialized services.
- Company
- PharmaEssentia attempts to reimb its first new drug BESREMi
- by Eo, Yun-Ho Apr 12, 2023 05:53am
- The Taiwanese pharmaceutical company PharmaEssentia is attempting to list its first new drug ‘Besremi’ for reimbursement. According to industry sources, PharmaEssentia submitted an application for the reimbursement of its polycythemia vera treatment, Besremi (Ropeginterferon alfa-2b) on March 28th. Polycythemia vera is a rare blood disorder where a somatic cell mutation in the bone marrow abnormally activates bone marrow function and produces excessive red blood cells. It has a short survival period and is so fatal that 10~15% of patients with polycythemia vera develop myelofibrosis or leukemia within 10 years. Although hydroxyurea had been used as the standard of care, it was difficult to fundamentally cure the disease with hydroxyurea, and patients who could not be treated with hydroxyurea had limitations as there were practically no drugs available for them in Korea’s domestic reimbursement environment. Besremi is an interferon treatment that selectively removes JAK2 mutations that cause polycythemia vera. In Korea, the drug received approval in October 2020 to treat low-risk and high-risk patients with polycythemia vera without symptomatic splenomegaly. The drug demonstrated its potential as a radical treatment for polycythemia vera in patients who had not received cytoreduction therapy or received less than 3 years of treatment with hydroxyurea. Therefore, whether the only interferon treatment option approved for polycythemia vera will be reimbursed is gaining attention. Besremi demonstrated its efficacy and safety in the Phase III PROUD/CONTINUATION-PV trial that was conducted on polycythemia vera patients. Trial results showed that 53% of the patients in the Besremi arm achieved a complete hematological response, an improvement compared with the hydroxyurea patient arm (38%). The response rates at 72 months were high at 80.4% and 65.3% in low-risk and high-risk patients, respectively, and showed high hematologic and molecular responses. Regardless of their risk, patients treated with Besremi did not require phlebotomy even 6 years after administration. Sung-Soo Yoon, Professor of Hemato-Oncology at Seoul National University Hospital, said, “Polycythemia vera is currently left unattended in terms of reimbursement in Korea. Patients that show no response to hydroxyurea, the current standard of care, had no appropriate treatment options available for use and had no option but to wait for their condition to progress further. He added, “Korea’s clinical practice guidelines recommend interferon and ruxolitinib as second-line treatment for patients who show intolerance or are refractory to hydroxyurea, but both drugs are currently unreimbursed, and other interferon treatments have withdrawn from the Korean market. Therefore, as the only treatment option available, Besremi is in urgent need of reimbursement.” Besremi is recommended as a first-line or second-line treatment for polycythemia vera by the National Comprehensive Cancer Network (NCCN) and European Leukemia Network (ELN) guidelines, regardless of previous treatment experience.
- Company
- Luxturna, a one-shot retinal disease treatment
- by Eo, Yun-Ho Apr 11, 2023 06:11am
- Luxturna, a one-shot retinal disease treatment, is once again aiming to enter insurance coverage. As a result of the coverage, Novartis Korea recently resubmitted a reimbursement application for Luxturna, a treatment for Inherited Retinal Dystrophy. This is a quick resumption of the process after the HIRA's non-reimbursed decision last month. As the company's will to be listed on the salary is firm, it remains to be seen whether this re-challenge will be successful. This drug submitted an application for reimbursement in September 2021, but there was no progress in the listing process so far, and it was first introduced this year. Although it is expensive one-shot gene therapy, it seemed difficult to register because the disease is not directly related to life. Luxturna restores the function of the defective or defective RPE65 gene, one of the causes of IRD, by replacing it with a normal gene with just one administration. This means that the fundamental treatment of the disease is possible. Therefore, the key is how much Luxturna can achieve the value of preventing blindness. This drug was designated by the US FDA as Breakthrough Therapy in 2014, Orphan Drug in 2016, and Priority Review in 2017, and obtained expedited approval in 2017. IRD is a rare and intractable disease in which vision loss occurs due to mutations in the gene responsible for the structure and function of retinal photoreceptors. It includes more than 20 different eye diseases, and there are about 300 causative genes. IRD caused by RPE65 gene mutation causes an abnormality in the visual cycle in the retina, which converts visual information entering the eye into nerve signals and transmits them to the brain. RPE65 gene mutation reduces the RPE65 protein, which is essential for visual circuitry, and destroys retinal cells, gradually narrowing the field of vision and eventually leading to blindness. Luxturna proved its effectiveness through a phase 3 clinical trial targeting patients with hereditary retinal diseases in which a biallelic mutation in the RPE65 gene was confirmed. As a clinical result, the functional vision of patients treated with Luxturna improved statistically significantly compared to the control group who did not receive treatment at 1 year of treatment. As a result of evaluating the average score of the Multi-Luminance Mobility Test (MLMT), which evaluates the ability to pass through an obstacle course of various heights in various levels of illumination by recreating a daily walking environment, as the primary evaluation variable at 1 year of treatment, Luxturna treatment group The score change of was 1.8 points, which was 1.6 points higher than the control group's score change of 0.2 points.
- Company
- One-shot CAR-T tx, approved for domestic items
- by Eo, Yun-Ho Apr 11, 2023 06:11am
- According to related industries, Janssen Korea's Kavicty was approved last month, and Novartis Korea's Kymriah obtained additional approval for indications on the 5th. The second domestically approved CAR-T new drug, Kavicty, is an anticancer drug that inserts genetic information to recognize BCMA into the patient's immune cells (T cells) and then injects these T cells into the patient's body. B-cell maturation antigen, which is selectively expressed during plasma cell differentiation and not expressed in other major organs, represents an ideal target for plasma cell cancer (multiple myeloma). This drug is indicated for patients with relapsed or refractory multiple myeloma who have received at least four prior therapies, including ▲proteasome inhibitors ▲immunomodulators, and ▲anti-CD38 antibodies. In the case of Kymriah, the indication was expanded to treat adult patients with recurrent or follicular lymphoma after two or more treatments. With this expansion of the indication, Kymriah ▲relapses or secondary relapses after transplantation and subsequent relapses or refractory B-cell ALL (Acute lymphoblastic leukemia) and ▲ in pediatric and young adult patients under the age of 25 A third indication was obtained following recurrent or diffuse large B-cell lymphoma after two or more systemic treatments. Kymriah's new indication was based on ELARA, a phase 2 clinical trial targeting adult patients with relapsed or refractory follicular lymphoma (n=97). As a result of the study, the Overall Response Rate was 86.2%, including 69.1% of Complete Remission. Meanwhile, in March 2021, it was approved as a domestic advanced regenerative medicine bio law No. 1 treatment, and in April 2022, insurance benefits are applied to the two previously approved indications.
- Company
- Roche and Korea BIO offers opportunity to domestic companies
- by Hwang, Jin-joon Apr 11, 2023 06:08am
- KoreaBIO and Roche are hosting an open innovation event(Pic: KoreaBIO) The Korea Biotechnology Industry Organization will be providing opportunities for technology transfer and overseas expansion of domestic biopharmaceutical companies. For this purpose, Korea Bio plans to first cooperate with the multinational pharmaceutical company Roche. According to industry sources on the 10th, Korea BIO is planning to hold a ‘Korea BIO x Roche Partnering’ open innovation event on the 9th of next month. The event will be held on and offline at Roche Korea’s head office in Gangnam, Seoul, and be attended by groups wishing to partner with Roche. The event will offer one-on-one meetings between global pharmaceutical companies and domestic biopharmaceutical companies. Korea BIO planned the event to provide opportunities for domestic pharmaceutical and biohealth companies to receive a diagnosis on their commercialization potential for technology transfer and overseas expansion, etc. Domestic pharmaceutical and biohealth companies wishing to engage in technology transfer and joint research with Roche can submit an application, and prepare nonconfidential company introduction materials, personal information consent form, and company introduction material consent form to Korea Bio by the 24th of this month. The company introduction materials should only include only publicly available data. When the domestic pharmaceutical and biohealth companies submit the required documents, Roche Asia Partnering will select companies after review. Select companies will have on/offline meeting opportunities with Roche, and receive feedback related to the contents discussed. Then, a select few that wish to partner with Roche will receive the opportunity to have face-to-face meetings at Roche headquarters, global branches, and subsidiary research institutes. As collaboration areas, Roche suggested immunology, oncology, neurological disorders, research and development technology, personalized digital healthcare, rare diseases, and infectious diseases. If approved, the collaboration will be carried out with its Genentech Research Center, Roche Innovation Center Basel, Roche’s Shanghai Innovation Center, Global Product Development Department, and Product Strategy Department, etc. The industry believes that Korea BIO's open innovation project will be an opportunity for domestic companies to receive feedback from multinational pharmaceutical companies on their direction of pipeline research, further required research, and the marketability of their candidate substances. Starting with Bayer in 2021, Korea BIO had held open innovation partnering events with Boehringer Ingelheim, Novartis, French Healthcare Club, and CJ in the same year.
- Company
- Two types of RET-targeted anti-cancer drugs for minority pts
- by Eo, Yun-Ho Apr 10, 2023 05:52am
- It does not seem easy to enter the insurance coverage of RET-targeted anti-cancer drugs targeting a very small number of patients. According to related industries, Retevmo of Lilly Korea failed to pass the HIRA held on the 6th, and Roche Korea's Gavreto submitted an application for benefits last year, but it has not yet been presented to the Cancer Disease Review Committee, and discussions are slow. However, in the case of Retevmo, as the decision to re-discuss was made, there is room for hope. Although the application for Gavreto was delayed compared to Retevmo, there is no news about it, despite the strong tendency of the government to evaluate drugs with the same mechanism. Retevmo and Gavreto both obtained FDA approval in March. Retevmo was a bit early for global first permission. Retevmo obtained marketing approval from the US FDA in May last year and Gavreto in September last year. Retevmo was approved for two indications of non-small cell lung cancer and thyroid cancer, and for indications of Gavreto, thyroid cancer was added in December of the same year after approval as a lung cancer treatment. Since these drugs suppress not only the primary mutation of the RET gene but also the secondary mutation that causes resistance to chemotherapy, it was expected that they would be able to solve the unmet demand in various types of cancer, but they are experiencing difficulties in the insurance coverage process. Cho Byung-cheol, a professor at the Lung Cancer Center at Yonsei Cancer Center, said, "Until now, there were no chemotherapy options for patients with RET gene mutation cancer, so we had no choice but to undergo chemotherapy in the same way as general cancer patients. It can be an alternative for patients who have had difficulties with relatively low anti-cancer toxicity.” Meanwhile, in the LIBRETTO-001 clinical trial, Retevmo recorded a response rate of 64% in non-small cell lung cancer patients who had previously received platinum chemotherapy and an 85% response rate in the newly diagnosed group. Gavreto significantly reduced tumors by 58.8% in non-small cell lung cancer patients who had previously received chemotherapy in the Arrow trial. In patients diagnosed for the first time, the response rate was 72%.
- Company
- It is difficult to secure domestic funding for bio ventures
- by Hwang, Jin-joon Apr 10, 2023 05:51am
- Head of KDDF, Muk Hyun-sang, is presenting major business plans for this year. (Photo: Dailypharm)"It is not easy to change KDDF's funding method. It is possible to raise funds only when investors flock to it, but in order to attract funds from the United States, we are planning an event to invite major US VCs to invest in Korean bio ventures in July. are doing." Muk Hyun-sang, head of KDDF, made this announcement at a press conference held on the 5th at the Korea Chamber of Commerce and Industry's mid-sized conference room in Jung-gu, Seoul to mark the 2nd anniversary of KDDF's launch. Director Muk Hyun-sang explained, "I thought KDDF funds were priming water," and explained, "If you support about 10% of the necessary R&D costs, the company has raised 15 billion won by itself, but it is currently difficult." "It is difficult to increase the amount of money that can be supported by KDDF," he said. "We are looking for a way to get funds from the outside. The US VC invitation event plan is one of the ways to connect financing." KDDF plans to invest a total project cost of 2.1758 trillion won by 2030. The business goals are 60 global technology transfers worth 20 billion won or more, 35 cases worth 100 billion won or more, 4 new drug approvals from the FDA and the EMA, and the creation of one global blockbuster new drug with annual sales of 1 trillion won or more. Director Muk said, “The business carried out by KDDF cannot be seen as a general state-sponsored new drug development project.” there is, and if a company is short of funds, KDDF should create an opportunity to raise funds." KDDF is also planning to carry out 'ADCaptain' to support the ADC project, which is considered a next-generation treatment this year. KDDF plans to prioritize pipelines targeting pancreatic cancer, ovarian cancer, and triple-negative breast cancer among solid cancers and strengthen support through the ADCaptain project. It plans to provide R&D subsidy through investment without equity dilution and support up to 20 million dollars by 2025. From this year to next year, it plans to establish a joint operating committee through cooperation between participating companies and investment companies in the form of a virtual company. A science development advisory committee will also be operated. KDDF plans to select three tasks as leading material development tasks and support 800 million won each for two years. When it enters the development stage after 2024, it plans to establish a corporation and distribute shares. The CEO will be nominated by the company in charge of clinical development. The chairman of the board of directors is appointed by KDDF. R&D funds will be raised through KDDF R&D subsidy, global VC investment, and government fund investment. The required investment is expected to be 24 million dollars. Director Muk said, "It has become KDDF's mission to raise funds. We submitted a budget plan related to new drug development worth 250 billion won to the Abu Dhabi Investment Authority through the Ministry of Strategy and Finance, and we will contact Singapore's Temasek."
- Company
- GemVax’s Alzheimer’s Tx GV1001 receives IND approval
- by Kim, Jung-Ju Apr 07, 2023 05:55am
- On the 4th, GemVax & KAEL announced that it had received investigational new drug (IND) approval for the Phase II trial of its Alzheimer’s treatment candidate, GV1001, in 7 European countries as planned. With its procedures for clinical trial approvals in the 7 European countries complete, the company plans to accelerate the clinical trials in Europe, starting with the initiation of the clinical trial in Spain. A GemVax official said, “With approval complete in 7 European countries, we expect the clinical trials we initiated in Europe to speed up. The global clinical trial of our Alzheimer's disease treatment GV1001 is progressing smoothly in the U.S. and Europe, therefore, we will do our best to achieve significant clinical results." The company plans to enroll a total of 185 patients, 77 from the US and 108 from Europe in the global clinical trial for GV1001. The company explained that the first patient was registered in the US last October and that a total of six patients have been registered so far. The clinical trial will evaluate the efficacy and safety of GV1001 (0.56 mg and 1.12 mg) subcutaneously as a treatment for mild-to-moderate Alzheimer's disease (AD) for 53 weeks (12 months). In addition, GemVax has also received approval from Korea’s Ministry of Food and Drug Safety to conduct a clinical trial on GV1001 as a treatment for progressive supranuclear palsy (PSP). This is expected to become the first clinical trial conducted in Korea for PSP. As GV1001 is being studied for PSP in addition to the Alzheimer's disease clinical trials that are being actively conducted in Korea and abroad, GV1001’s scope is expected to expand further to cover a range of neurodegenerative diseases.
- Company
- The dilemma of price cuts for Lipiodol and Fattiodol
- by Nho, Byung Chul Apr 07, 2023 05:55am
- There are many opinions of concern that the two items of X-ray contrast medium registered as essential medicines may fall into a situation where supply is not possible. According to the industry, price cuts are scheduled for Lipiodol and Fattiodol on the 1st of next month, and the price of raw materials for these products is high. The original product, Guerbet Fattiodol Ultra, obtained domestic approval in 1998 and was recognized for its insurance price of 52,560 won in 2016. Afterward, the pharmaceutical company filed an application for drug price adjustment with the health authorities in 2018, citing lower margins compared to cost, and was found to have led to a drug price increase of 190,000 won, a 261% increase from the previous one. Lipiodol is 189,224 won in January 2022, 133,000 won in September 2022, 189,224 won in September 2022, and 133,000 won in January 2023. The drug price is scheduled to be reduced to 1,745 won. The situation is equally bad for Dongkuk Fattiodol, the only generic drug in the market approved in 2020. At the time of registration, the additional drug price was recognized and 59.5% (113,050 won) of 190,000 won was recognized, but the drug price is scheduled to be reduced to 101,745 won on the 1st of next month. Application for drug price adjustment is virtually the only way to raise or preserve drug prices, but it cannot be used because there are alternative drugs between Lipiodol and Fattiodol. If two pharmaceutical companies simultaneously stop supplying drugs due to lower margins following drug price cuts, a supply-demand crisis is expected. An industry insider said, "Estimating the cost of essential medicines and resolving the dynamics of drug price cuts is a mid-to-long-term task that the health authorities must solve." The main component of Lipiodol is Ethyl Esters Of The Iodised Fatty Acids Of Poppyseed Oil, which is used for lymphography, salivary gland imaging, carotid artery chemoembolization for liver cancer, and hysterosalpingography. Last year, Lipiodol and Fattiodol last year's performance were about 2.8 billion won and 36 million won, respectively.
