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- 2025-12-26 08:58:12
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- Amitiza can be prescribed at general hospitals
- by Eo, Yun-Ho Jun 29, 2021 05:46am
- Amitiza, a chronic constipation drug, can be prescribed at general hospitals. According to related industries, Amitiza(Lubiprostone), which is conducting exclusive promotion activities in Korea through contracts with Takeda Pharmaceuticals, passed the drug committee (DC) of 42 medical institutions nationwide, including AMC and Severance Hospital. Amitiza is used to treat certain types of constipation (chronic idiopathic constipation, irritable bowel syndrome with constipation). Chronic idiopathic constipation has an unknown cause and is not due to diet, other diseases, or drugs. Lubiprostone is also used to treat constipation caused by opioid medications in people with ongoing pain due to medical conditions other than cancer. and was released in February last year. Amitiza, co-developed and marketed by Takeda with Sucampo Pharmacutics, obtained market approval from the U.S. FDA in 2006. Amitiza facilitates CIC-2 chloride channels to increase fluid secretion in the small intestine to relieve constipation symptoms. Clinical trials showed that 60% of constipation patients succeeded in natural bowel movements within 24 hours of taking Amitiza. Amitiza was sold about ₩688.2 billion last year alone in major countries including Japan, the United States and Europe. It is an oral bicyclic fatty acid that selectively activates type 2 chloride channels in the apical membrane of the gastrointestinal epithelium, resulting in increased fluid secretion Lee Kwang-jae, Professor of Gastroenterology at Ajou Medical School (chairman of the Korean Society of Neurogastroenterology and Motility), said, "As it is the first new mechanism in Korea, we expect it to be a primary treatment option for chronic constipation patients who experience daily discomfort."
- Company
- Select the right initial treatment for kidney cancer
- by Jun 29, 2021 05:46am
- Cancer immunotherapies are receiving the spotlight in the treatment of kidney cancer. Demonstrating superiority over existing therapies, these drugs are quickly gaining ground in the field of kidney cancer treatment. Recently, MSD’s cancer immunotherapy ‘Keytruda (pembrolizumab) received approval as first-line treatment in combination with Inlyta(axitinib). Afterward, the immuno+immunotherapy combo ‘Opdivo (nivolumab)+ Yervoy (ipilimumab)’ also received approval as a first-line treatment option. Dr. Chan Kim, Professor of Medical Oncology/Hematology at CHA Bundang Medical Center believes that the use of cancer immunotherapies will broaden in the field of kidney cancer. And there’s ample grounds to support Kim’s belief. Keytruda in combination with a different targeted therapy, ‘Lenvima (Lenvatinib)’ has recently produced even more superior data in a clinical trial. However, limitations do exist. Currently, cancer immunotherapies are approved only for the first-line indication. Therefore, if the patient had previously used other treatments, they may not be prescribed cancer immunotherapy drugs. Therefore, patients with Stage IV kidney cancer must carefully consider and select their first treatment. Dailypharm met with Professor Kim to seek his insight on the significance and prospect of cancer immunotherapy drugs in the field of kidney cancer. Professor Chan Kim-How has the kidney cancer treatment environment changed with the introduction of cancer immunotherapies? = Kidney cancer is a field known for its poor response to general chemotherapy or radiotherapy treatment. Due to this, cytokine-based immunotherapy has been used as an option for over 20-30 years in the field, but even this option has not been broadly used because its objective response rate is only around 10-20%, with serious side effects. This treatment paradigm for kidney cancer has completely changed with the introduction of cancer immunotherapy drugs (immune checkpoint inhibitors). Cancer immunotherapy drugs have fewer side effects than previous drugs and can be used safely even in elderly patients. Most of all, it showed a good therapeutic effect. However, immunotherapy drugs by themselves were not enough to produce satisfactory results as the objective treatment response rate of immunotherapy drugs alone was around 25-30%. As a result, attempts to use immunotherapies in combination with targeted therapies have been made, and clinical studies on this combination were released for kidney cancer in 2019. Results showed that the immuno+targeted therapy combination achieved a twice higher ORR than monotherapy, with an ORR of 55-60%. The uncrossed barrier of 30% was finally overcome. -Were many combination therapies implemented in practice after the data was presented on the immuno+targeted therapy combination? How effective is it in practice? =Use of the combination increased explosively after the presentation. In Korea, Keytruda in combination with the targeted therapy Inlyta is most commonly used. Much treatment data has been accumulated on the combination since its introduction in September 2019. Our hospital presented data on 42 kidney cancer patients who were treated with the Keytruda+Inlyta combination from September 2019 to March 2021 at the 47th Annual Meeting of the Korean Cancer Association that was held from the 17th to 18th this month. One key thing to note is that at the data cut-off point (June 3rd, 2021), the ORR was 54.3%, an excellent rate that is comparable to the clinical trial results. Also, among the patients, 2.9% achieved a complete response and 51.4% achieved a partial response. The median progression-free survival was 12.4 months, and the median OS was not reached in our study. In particular, tumor size in patients with aggressive tumors whose symptoms are difficult to control reduced significantly. 85% of the patients survived, and 63% are still continuing their treatment with the combination therapy. The 1-year survival rate is expected to be around the 90% range. In general, Real World Data (RWD) often does not produce as good a result as clinical trials that were conducted in controlled environments. In this context, the fact our results in the field showed a 90% survival rate that is similar to the clinical trial is encouraging news. -How would you interpret the 42 month long-term follow-up data on Keytruda+Inlyta that was recently presented in the 2021 ASCO Annual meeting? =The academic society had been unsure whether the combination would work in the long-term The data that was presented at the ASCO meeting holds significance as it demonstrated the long-term effect of Keytruda+Inlyta. More specifically, in the KEYNOTE-426 study, the overall survival of the combination therapy was 45.7 months, significantly longer than the 40.1 months when using the standard treatment, ‘Sutent (sunitinib).’ PFS also showed a significant difference of 14.7 months vs 11.1 months. OS at month 42 was 57.5% vs. 48.5%, respectively, and PFS at the same period was 25.1% vs. 10.6%, for the combination therapy group and Sutent group. ORR was 60.4% for the combination therapy and 39.6% for sunitinib. CR was also higher in the combination therapy group, being near 10%, compared to the 3.5% of sunitinib. -The Keytruda+Inlyta combination is currently approved only as a first-line treatment. Does this mean patients who already used other drugs do not have the chance to use the combination? =Yes. Patients often visit our hospital wanting to use Keytruda after using targeted therapies for a month or so. It is unfortunate, but these patients are not allowed to use Keytruda because it is only approved as first-line in Korea. This is why selecting the right initial treatment is ever so important for stage IV kidney cancer patients. If you hastily decide on using a treatment, it is highly likely that you may miss a good opportunity, so I ask the patients to make an informed decision after carefully collecting ample information in advance. -Recently, the Keytruda+Lenvima combination had also shown excellent, differentiated data results from previous kidney cancer treatments. =We have high expectations for the Keytruda+Lenvima combination. In the Phase III CLEAR study, the combination showed a median PFS of 23.9 months, which is over twice longer than the PFS shown in the Sutent group’s 9.2 months. The risk of mortality also decreased by 34% compared to the Sutent group. ORR of the combination therapy was 71%, and 16.1% of the patients reached complete response. The combination is expected to address all the limitations in effect and side effects that arose from previous treatments. If this combination is also approved in the future, 4 treatment options (targeted therapy, immuno+immuno combination therapy, Keytruda+Inlyta, Keytruda+Lenvima) will become the established options used to treat kidney cancer. Among these, the Keytruda + Lenvima combination is expected to be the most anticipated option in the field. -What role would cancer immunotherapies play in the field of kidney cancer in the future? =Cancer immunotherapies are already a well-established treatment option in kidney cancer, and its use will continue to expand in the future. I believe the new treatment trend would be for low-risk groups to first use targeted anticancer therapies and for mid-to high-risk groups to consider the use of immuno+targeted combination therapies. As the combination is yet non-reimbursed, not enough patients are benefiting from this effective treatment option. I hope the government will provide support as soon as possible in consideration of its excellent treatment effect.
- Company
- Attention focused on children’s NIP flu vaccine supply
- by Whang, byung-woo Jun 29, 2021 05:46am
- With the bid for the 8 million doses of influenza vaccine for seniors under the National Immunization Program nearly compete, the pharmaceutical industry is intently focused on the supply amount and bid that will be set for the children’s NIP flu vaccines that will follow. According to the Korea Disease Control and Prevention Agency and the industry, the expected NIP quantity of influenza vaccines for those aged 6 months to 12 years will be around 4.6 million doses and will be supplied under a third-party Unit Price Contract. The reason why the pharmaceutical companies are paying attention to the NIP influenza vaccine (hereinafter referred to as flu vaccines) supply for children and adolescents is because the bid amount could affect the number of vaccines that will be released to the private sector in the future. Last year, due to concerns over a ‘Twindemic,’ where COVID-19 and influenza spread simultaneously, the subjects for NIP flu vaccines were temporarily expanded to include those in the 13 to 18-year range, increasing the supply by 1.54 million people’s worth. From this year's perspective, this means that if the flu vaccines for adolescents are removed from the NIP supply this year, that amount will now return to the private sector. Generally, the third-party unit price contract for children’s flu vaccines under the NIP are made without a procurement contract. When the pharmaceutical company supplies flu vaccines to vaccinating medical institutions, the institutions vaccinate eligible children and receive expenses for the vaccination and execution from their local public health centers. The pharmaceutical companies also receive the price for the vaccine from public health centers. When the pharmaceutical company supplies flu vaccines to vaccinating medical institutions, the institutions vaccinate eligible children and then receive expenses for the vaccine and its administration from their local public health centers. The pharmaceutical companies also receive the price for the vaccine from the public health centers. Currently, around 5.2 million children and adolescents are eligible to receive the NIP flu vaccine based on the resident registration statistics in May. The NIP inoculation rate is expected to be around 80% of the eligible population, which means that NIP will roughly require 4.2 million doses. Adding the 500,000 that need to be inoculated twice to the supply, the total amount required will be around 4.7 million doses. Most domestic companies will take part in the bid as NIP suppliers for the pediatric flu vaccines, and Sanofi, which is known to have ramped up its flu vaccine volume by nearly 30% in the absence of SK Bioscience, is also expected to participate in the bid. The pharmaceutical industry expects the total vaccine supply, including the NIP amount, will be around 26 million doses this year. Taking into account the various factors, some believe that the competition among pharmaceutical companies will intensify as the number of flu vaccines released into the private market will be much greater than expected compared to the previous year. However, there also lies the possibility that these expectations will be reversed, as the eligibility age for NIP may continue to be expanded this year in line with the probable approval of the supplementary budget. Analysts predict that supplementary budget requests this year will not be rejected as the Ministry of Economy and Finance had underestimated last year's tax revenue by around 32 trillion won and will be reflecting this amount in the budget. At least, the NIP vaccine age expansion plan will unlikely be rejected due to the lack of a budget. In addition, NA member Jong Sung Lee of the People Power Party had pointed out that NIP for adolescents was virtually nonexistent except for the supplementary budget bill approved in 2020 to inoculate adolescents aged 14 – 18 years old. This pressure from the NA may also be positively reflected in the supplementary budget request. An official from a domestic pharmaceutical company said, “The total NIP amount will be determined according to whether the NIP age range will be expanded or not. The rest will be distributed in the private market. It’s not about whether we agree or disagree to the age expansion plan – the nay or yay needs to be sorted out as soon as possible so we can plan measures accordingly.” Also, the pharmaceutical industry believes that COVID-19 vaccination will be an important variable in establishing a competitive strategy for the flu vaccine market. “This year’s flu vaccine market size may be determined by the COVID-19 vaccination rate this year," a Sanofi official said. "The government will need to provide guidelines for inoculations as the COVID-19 vaccination completion period coincides with the flu vaccination period that was announced by the government."
- Company
- MET inhibitor ‘Tabrecta’ to overcome Tagrisso resistance?
- by Jun 28, 2021 05:50am
- A study that attempts to address the resistance issue by using the first-ever MET inhibitor ‘Tabrecta’ in combination with the EGFR-TKI ‘Tagrisso,’ will be conducted in Korea. According to the Ministry of Drug and Food Safety on the 25th, Novartis Korea’s application to conduct a Phase III trial on its non-small cell lung cancer treatment ‘Tabrecta (capmatinib)’ was approved that day. Tabrecta is the first-ever MET inhibitor to be approved by the U.S. FDA and was approved in June last year. In Korea, the drug has been designated as an orphan drug by the MFDS in the pre-approval stage. The new clinical trial that will be conducted by Novartis will be studying Tabrecta in combination with Tagrisso (Osimertinib). More specifically, the study will evaluate the treatment effect of Tabrecta+Tagrisso in comparison to platinum-based chemotherapy in patients with non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation, T790M negative, mesenchymal-to-epithelial transition factor (MET)-amplified who progressed following treatment with 1st/2nd generation EGFR tyrosine kinase inhibitors (TKIs) or Tagrisso. MET amplification is one of the known causes of EGFR TKI resistance, in which an EGFR-inhibited cancer cell activates alternative signaling pathways to escape inhibition. It is found in around 25% of all patients treated with Tagrisso and is considered the most commonly observed alteration with C797S mutations associated with resistance to Tagrisso. No treatment that targets the abovementioned mutations currently exists, therefore, patients who develop resistance have no option but to use cytotoxic agents. Thus, work to address these Tagrisso-resistant mutations has been continuing around the world. AstraZeneca is currently conducting a Phase II study on combination therapy using Tagrisso with its new MET inhibitor drug substance ‘savolitinib (product name: Orpathys).’ Savolatinib is a new lung cancer drug in development by AstraZeneca and the Chinese pharmaceutical company, Hutchison China MediTech (Chi-Med). The drug received its first approval in China on the 24th. In the first cohort study that was conducted initially on 46 patients, the combination was associated with an objective response rate (ORR) of 52% with 24 partial responses The median duration of response (DOR) was 7.1 months. In the second, the combination yielded an ORR of 28%, with 12 partial responses. The median DOR was 9.7 months However, the savolitinib+Tagrisso combination showed more side effects in the cohort study. Jassen and Yuhan Corp. is also developing a combination of Rybrevant (amivantamab) and Leclaza (Lazertinib) that targets MET amplification. According to a paper recently published at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, the combination resulted in a 36% ORR, with one complete response and 15 partial responses. Rybrevant and Leclaza are each currently approved in the U.S and Korea.
- Company
- Intra-articular injection Conjuran can be reimbursed
- by Moon, sung-ho Jun 28, 2021 05:49am
- As the age of aging population begins in earnest, the number of osteoarthritis patients is increasing, and the market for related treatments is also heating up. Competition among pharmaceutical companies is fierce as various products of "Intra-articular injection," which has recently been in the spotlight, are newly included in the benefit. According to the pharmaceutical industry on the 23rd, the HIRA has recently been confirmed to have changed the reimbursement standard related to "treatment materials for Intra-articular," which is called joint strength injections, since June. Collagen is added to the existing intra-pulmonary infusion treatment material. Specifically, patients with knee osteoarthritis were added not only sodium polynucleotide but also collagen, including a total of two components of joint strength injections. An official from the HIRA said, "The addition of collagen is the result of the application for the benefit registration while the related products are recognized as new medical technology." The HIRA clarified the method and number of injections with Polynucleotide administered up to five doses per six months and collagen administered up to five doses per six months (within 180 mg of total collagen dose). These categories set patient copayment rate of 80% for Selective Health Benefit targets. PharmaReaserch's Conjuran is a Polynucleotide-based joint strength injection, and CartiZol is a collagen-based joint strength injection. Among them, PharmaReaserch's Conjuran has been subject to Selective Health Benefit since the second half of last year, leading the osteoarthritis treatment market as the administration of patients has increased, led by orthopedic and rehabilitation clinics. Recently, it had an influence on general hospitals by conducting a co-promotion with SK chemicall. Conjuran began competition with Sewoncellontech's CartiZol, a collagen-based injection of joint strength. Due to the increase in arthritis patients due to the aging population, competitors such as CGBIO also predicted challenges in the joint steel injection market. Osteoarthritis treatments market is growing. According to the NHIS, the number of arthritis patients increased by about 10% in five years from 4.4 million in 2014 to 4.86 million in 2018. "As the population ages and the number of patients with knee osteoarthritis increases, joint strength injections are in the spotlight recently," an official from a pharmaceutical company said. "In particular, the treatment market will begin to compete with companies." "The current market for this treatment is worth ₩100 billion a year, and it will grow year by year," he predicted
- Company
- Will the new social distancing benefit the prescription mkt?
- by Chon, Seung-Hyun Jun 25, 2021 05:51am
- New social distancing rules will be applied from next month. The restrictions set on private gatherings will be eased, and the operating hours of multi-use facilities will also be extended. The pharmaceutical industry has its eyes on whether the outpatient prescription market, which has contracted due to a decrease in outdoor activities, will take a turn for the better under the new regulations. According to the pharmaceutical research institution UBIST on the 21st, outpatient prescription in May this year was around 1.15 trillion won, down 1.1% YoY. This is a 10.4% fall compared to the market’s performance in May 2 years ago. This downward trend has been continuing since last month, as outpatient prescription in April was also reduced by 0.3% YoY to record 1.18 trillion won. The accumulated outpatient prescription in May this year was 5.91 trillion won, down 2.4% from the same period of the previous year. The aggregate prescription sales in May were 5.91 trillion won, down 2.4% YoY. The prescription market was hit the hardest in April to May last year due to the aftermath of the COVID-19 outbreak. Monthly outpatient prescription sales trend (Unit: 100 million won, Source: UBIST) Prescription in April and May last year were each lower by 8.7% and 9.4% YoY. At that time, with the COVID-19 spreading in full pace, patients with chronic diseases such as hypertension and diabetes chose to avoid visiting medical institutions by receiving prescriptions for the long-term, creating a void in the prescription market. However, performance in April and May this year are even worse off than the prescription void period of the previous year. The prescription market, in general, has been sluggish compared to the previous year. Prescription sales in January and February this year were also down by 7.0% and 5.6% YoY, respectively. Experts pointed to the prolonged COVID-19 as the cause of sluggish sales in January and February this year. The increased interest in personal hygiene after the spread of COVID-19, including hand-washing and mask-wearing, may have greatly reduced the incidence of infectious diseases, leading to a decrease in visits to medical institutions. Although the performance had improved temporarily in March, marking a 1.9% increase, sales has again turned downward from April. Analysis predict that the increased personal hygiene management in the prolonged COVID-19 will inevitably continue to impact the prescription market for infectious diseases, etc., even though the flu season had ended. Another reason that was raised was that the social distancing level that was elevated since the end of last year due to a surge in COVID-19 cases may have led to decreased visits to medical institution. However, with eased social distancing restrictions to be applied from next month, many are expecting the prescription market to pick up. According to the Ministry of Health and Welfare’s Central Disaster and Safety Countermeasures Headquarters (CDSCH), a new, 4-level social distancing plan will be applied from next month. The key indicator used will be the weekly daily average confirmed cases per 100,000 people. Level 1 applies when the rate is less than one in 100,000, Level 2 when the rate is between 1 and 1.9, Level 3 when the rate is between 2 and 3.9, and Level 4 for 4 or greater. In the capital area, Level 1 will be applied if the weekly daily average is less than 250, Level 2 for 250 or more, Level 3 for 500 or more, and Level 4 for 1,000 or more. Regarding private gatherings, no restriction will apply in Level 1, and up to 8 people may meet at Level 2. Local governments may choose not to apply the 8-person restriction at their own discretion. In other words, the restrictions on private gatherings for 5 or more people that was enforced since December 23rd of last year may be eased down from next year. Also, the closing hours may be extended for multi-use facilities. Industry officials expect the increase in outdoor activities will increase the number of visits to medical institutions, and benefit the prescription market. Many believe that the sluggish sales in the prescription market will not continue long as drug use continues to increase with the increase in the elderly population and people with chronic conditions. Contrary to the tourism and culture industry, which is facing an extreme crisis after the COVID-19 outbreak, the pharmaceutical industry is more influenced by the patients’ demand rather than the external environment. Therefore, experts believe, the continued social distancing restrictions set in Korea will not lead to a sudden recession of the pharmaceutical market. Also, hopes that that the prescription market will rebound due to increased COVID-19 vaccination area also present. Recently, vaccination has sped up, and the cumulative total number of those vaccinated exceeded 15 million. This means that over 15 million people visited medical institutions in about four months since March, when vaccinations first begun. With more patients visiting medical institutions for COVID-19 vaccinations, some expect this will also lead to an increase in other drug use. An industry official said, “There is a high possibility that the prescription market will recover as some people who have been hesitant to visit hospitals due to COVID-19 have been requesting additional prescriptions for their usual medications during their vaccination visits.”
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- Telemisartan is excluded from impurity survey
- by Kim, Jin-Gu Jun 25, 2021 05:51am
- The MFDS has expanded the scope of the impurity investigation to ARB drugs as a whole. However, Telmisartan·Azilsartan·Eprosartan were excluded from the list of additional investigations. The pharmaceutical industry understands that Telmisartan was excluded from the impurity survey because it does not have a tetrazole ring. The MFDS said on the 23rd, an official letter was sent to analyze and evaluate the possibility of impurities occurring in Olmesartan, Fimasartan, and Candesartan. The company that owns the drug in question shall analyze and submit the possibility of 'AZBT/Azido Methyl Bipheny Tetrazole' by the 22nd of next month. The scope of impurity investigation has been expanded from the existing Irbesartan·Losartan·Valsartan to the entire ARBs. A total of nine ARB-based drugs are licensed in South Korea. Losartan, Valsartan, Azilsartan, Eprosartan, Olmesartan, Fimasartan, Candesartan, Irbesartan and Telmisartan. Telmisartan, Eprosartan and Azilsartan were excluded from further investigations by the MFDS. 797 products containing Telmisartan such as Micardis, 5 Azilsartan products such as Edarbi, and 2 items of Eprosartan such as Teveten do not need to be further investigated. ◆AZBT and NDMA can occur during the synthesis of tetrazole rings Tetrazole ring molecular structure. Many ARBs contain this molecular structurThe pharmaceutical industry understands that the shape of each component's molecular structure influenced the MFDS' decision on the scope of the investigation. The MFDS ordered an investigation into impurities, limiting only ingredients with "tetrazole rings" in molecular structure. The MFDS estimated that Azido impurities are produced by reacting 'Br-OTBN (4'-Bromomethyl-2-cyano-biphenyl) and 'Sodium Azide (NaN3). Br-OTBN is the main intermediate in the synthesis of tetrazole rings. Add a reagent called Sodium Azide and the tetrazole ring is synthesized. In other words, the reagent (azide) used to synthesize tetrazole rings may have been produced as a "suspicious substance (AZBT)" in response to certain conditions. It is estimated that NDMA (N-Nitrosodimethylamine), which was detected during the Valsartan crisis in 2018, also occurred after a similar process. At that time, the MFDS (DMF), which was used as a solvent to make the tetrazole ring, was decomposed into dimethylamine during the high temperature process, and was produced by reacting to NaNO2. The same is true of NDEA (Nitrosodiethylamine). It is believed to have been produced by reacting to the impurities dimethylamine and nitrite contained in the triethanolamine (TEA) itself used as reagents. The MFDS judges that ARB drugs, including tetrazole rings, are likely to develop AZBT or NDMA and NDA at any time. ◆Of 9 ARB drugs, six contain tetrazole rings Looking at the molecular structure of ARB drugs, tetrazole rings are found only in Eprosartan, Olmesartan,Fimasartan,Candesartan,Irbesartan, Losartan. This is not the case with Telmisartan, Azilsartan, and Eprosartan. The tetrazole ring determines whether the Ministry of Food and Drug Safety will order an investigation into the possibility of impurities. An official from a pharmaceutical company said, "Even if it is the same ingredient, the possibility of detecting impurities is divided depending on which reagent or solvent is used." "In addition, the possibility of occurrence varies depending on whether or not there is a tetrazole ring in the molecular structure. "In Telmisartan's case, there is little chance of impurities occurring because there is no tetrazole ring."
- Company
- Sillajen acquirer GFB seeks further partnership opportunity
- by Jun 24, 2021 05:55am
- "Using ShillaJen’s anticancer virus platform, we can add many new substances to be developed as novel drugs. Korea owns many excellent early-stage novel drug candidates, and we also may additionally introduce promising new substances in Korea." At the interview with DailyPharm, Ajit Gill, CEO of Greenfire Bio, Ajit Gill expressed his strong will to build additional partnerships with Korean bio-ventures in Korea. CEO Ajit Gill Greenfire Bio (GFB), a U.S. joint bio-venture firm of M2N that recently acquired Sillajen for 6 billion won, has been established by various industry experts including the company’s CEO Agit Gill who had previously headed Nektar Therapeutics, and CBO Sanjeev Munshi who had served over 20 years at MSD (U.S. Merck) as a BD reviewing and introducing new substances. During his service as head of Nektar Therapeutics from 1999 to 2006, Gill had contributed to raising the company’s market value to more than 20 trillion won. CBO Munshi had been in charge of searching biotech companies around the world to develop new drugs for intractable diseases such as Alzheimer's and NASH at MSD. Hanmi Pharmaceutical’s ‘efinopegdutide’ for nonalcoholic steatohepatitis (NASH) is also one of the numerous new drug substances he introduced at MSD, GFB, which has been developing the bio business with M2N Chairman Seo Hong-min, has been interested in developing new drugs using next-generation technology. In this context, Sillajen’s anticancer virus platform has caught the company’s interest. Anticancer virus, or oncolytic virus, induces immunogenic cell death (ICD) by loading viruses that have excellent penetration capabilities with anticancer substances. Globally, the interest in oncolytic virus is high, but no ‘game changer’ has emerged yet. Amgen’s Imlygic that was first introduced in the field did not produce a satisfactory return compared to the investment. However, GFB has a strong belief in the potential of the oncolytic virus market. Gill said, “With immuno-oncology drugs having a response rate around 30%, adding oncolytic virus to the immunotherapy can increase the rate to 50 to 60%. The vaccinia virus used in Sillajen’s next-generation platform has the benefit of being able to load various anticancer substances, due to its large size. Just looking at the monoclonal antibody market, we see many cases in which the bio-industry makes explosive growth with follow-up products that have been improved to complement the shortcomings of the earlier drugs, so there is no concern about the potential of the anticancer virus market." CBO Sanjeev Munshi He added, “For new technology, securing safety is important. Sillajen has the advantage in the market as the company had identified the safety of its platform through clinical trials for many years,” and expects that their accumulated new drug development know-how and financial firepower will create synergy when met with Sillajen’s leading technology. Regarding the increased market concern over the discontinuation of the Phase III trial on Pexa-Vec in 2019, Gill said, “Failing Phase III trials is common in the bioindustry. The point to focus on is whether we own a potential platform. However, we would need to establish a richer pipeline. Just one success is all we need to significantly raise the value of the company.” However, Gill took a cautious stance on the development of Pexa-Vec will continue, stating that the decision will be made after observing the data that will be released after a year. Instead, GFB is eagerly searching for new substances to apply to Sillajen’s platform. CBO Munshi has been focusing on discovering a substance with the highest possibility of success based on his experience at MSD as BD. Munshi said, “We have reviewed over 200 substances over the past 6 months. We want to find the most promising pipeline. Self-development is also a possibility, but it is more likely that we will acquire a substance through external partnerships.” In this sense, GFB is deeply interested in partnering with Korean bio ventures. Munshi said, “Korea owns abundant early-stage research data, but lacks development experience in the US., which is the world’s largest market. GFB can complement this area as the company has a high understanding of the global market and owns extensive global network experience. Please don’t hesitate to reach out anytime if you have an innovative new drug technology. Gill said, “Nektar Therapeutics was also once a 4-person company. It grew to a company with 800 employees when I left. In that time, I had signed countless contracts and raised the 1.5 billion fund in various ways. When combined, GFB’s BD expertise, M2N’s high capital, and SillaJen’s technology will be the right mix of all the essential elements necessary for the development of a blockbuster drug.”
- Company
- Benlysta can be reimbursed in general hospitals
- by Eo, Yun-Ho Jun 24, 2021 05:55am
- Benlysta, which has been covered by insurance benefits for the first time in seven years, can be reimbursed in general hospitals. According to related industries, GSK's Benlysta (Belimumab) has passed the drug committee (DC) of 20 hospitals nationwide, including Aju University Hospital, Chungnam National University Hospital and Hanyang University Hospital. Benlysta, prescribed for treatment of active systemic erythema lupus adult patients who are autoantibody positive, was non reimbursed by the Pharmaceutical Benefits Advisory Committee twice in December 2015 and November 2018. This is because it was difficult to prove cost-effectiveness as old drug such as Prednisolone, Hydroxychloroquine and Azathioprine are alternative drugs. Benlysta is eligible for active systemic ▲Lupus 18 years of age or older, who has been treating autoantibody positive for more than 3 months with standard therapy, if both ▲SELENA-SLEDAI 10 and above ▲ Anti-dsDNA antibody positive ▲ low complement (C3 or C4) conditions. Patients can be treated with 10% of their copay through special cases of calculating rare diseases. The administration method according to the benefit standard is recognized for an additional 6 months if SELENA-SLEDAI is reduced by more than 4 weeks after initial administration ▲ If the evaluation results of the first 24 weeks are maintained, the use is recognized for an additional 6 months. Lupus invades a variety of organs throughout his life, especially in major organs such as the heart, lungs, kidneys, and nerves, which can lead to irreversible damage and death Due to the nature of the disease, most patients are women of childbearing age, and 19% of pregnant women suffer from fetal death, loss of fetal development, low birth weight, and premature birth.
- Company
- PARP inhibitors for primary ovarian cancer can be reimbursed
- by Jun 23, 2021 05:54am
- PARP inhibitors "Jejula" and "Lynparza" are expected to be applied to primary maintenance therapy for ovarian cancer as early as the third quarter. This is limited to BRCA mutations, and most patients without mutations do not benefit. According to the pharmaceutical industry on the 21st, Takeda followed by Lynparza (Olaparib) of AstraZeneca.The pharmaceutical company Zejula (Niraparib) also passed the Pharmaceutical Benefits Advisory Committee of the HIRA and is in negotiations with the NHIS. It is predicted that both products will complete the process of registering their benefits in third quarter. 80 to 90% of all ovarian cancer patients with BRCA negative effects will be excluded from the benefits. Zejula applied for the benefit as an All-Comer regardless of the mutation, but the HIRA's Cancer Drugs Benefit Apparel Committee only recognized positive mutations. Takeda Pharmaceutical has chosen a strategy of preferentially registering salaries for training BRCA. For secondary and higher maintenance, both Lynparza and Zejula have BRCA negative adaptations, but they also did not pass. This is why ovarian cancer patients filed a petition to allow them to use new drugs for BRCA negative. The monthly cost of medicine for non reimbursement is about ₩4.5 million. Lynparza's quarterly sales have been on a gentle rise from ₩2 billion last year to ₩3.7 billion in the first quarter of this year. Zejula, on the other hand, closely followed Lynparza in the first quarter of this year at ₩3.2 billion, up from ₩1 billion last year.
