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- 2026-03-16 21:30:23
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- Ibrance safety is OK even in male breast cancer patients
- by Eo, Yun-Ho Aug 19, 2022 05:53am
- Breast cancer treatment Ibrance has added safety-related product information in male patients. The Ministry of Food and Drug Safety recently added a phrase that male patients also showed consistent safety profiles with women in post-marketing experience through updating the permits of CDK4/6 inhibitor Ibrance of Pfizer Korea. The measure was based on the results of post-marketing surveys and electronic health records in the United States, and the U.S. FDA expanded its indication to prescribe Ibrance to male patients based on the data in 2019. Male breast cancer is a rare disease that accounts for about 1% of all breast cancers, and most of the patients' mammary tumors are expressed in hormone receptors and are generally treated with endocrine therapy, and Ibrance combined therapy is possible for progressive cancer. But, Ibrance has not secured an indication for male breast cancer in Korea. Meanwhile, Ibrance recently reaffirmed its effectiveness, including the Overall Survival, through a large-scale Real World study. The study, published in the European Society for Medical Oncology Breast Caner 2022, retrospectively analyzed the data of 2888 actual patients prescribed Ibrance combination therapy and Aromatase inhibitor monotherapy. As a result, OS median of Ibrance was 53.4 months, and Aromatase inhibitor alone was 40.4 months. The risk of death in Ibrance combination therapy was 33% lower.
- Company
- US FDA approves Samsung Bioepis' high conc Humira biosimilar
- by Kim, Jin-Gu Aug 19, 2022 05:53am
- On the 18th, Samsung Bioepis announced that the U.S. Food and Drug Administration (FDA) approved the high-concentration formulation of its Humira biosimilar, ‘Hadlima 100mg/mL’ on the 15th (local time). The company plans to market the high-concentration Hadlima in the US market in July next year through its US marketing partner, Organon. Hadlima is used for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis. To improve patient convenience, the formulation will be offered to patients in a prefilled syringe (PFS) or autoinjector. The approval of the citrate-free, high-concentration Hadlima was based on clinical data from a clinical study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of Hadlima (100 mg/mL vs 50 mg/mL) in healthy volunteers. The low-concentration formulation (50 mg/mL) of Hadlima was previously approved by the FDA in July 2019. More than 5 million prescriptions of Hadlima had been made under various brand names since 2018. Byoungin Jung, VP and Team Leader of Regulatory Affairs at Samsung Bioepis, said, “With the FDA approval, we are now able to expand our treatment options to both the low- and high-concentration versions of Hadlima in the US. By leveraging our R&D expertise, manufacture, and supply chain management capabilities, we will continue our efforts to provide quality drugs to patients around the globe.”
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- Indication of Norvatis Beovu's DME was expanded
- by Aug 19, 2022 05:52am
- Novartis Korea announced on the 17th that Beovu, an Age-related macular degeneration treatment, has added diabetic macular edema (DME). Beovu is a treatment that inhibits neonatal vascular expression and retinal effusion leakage in combination with VEGF-A. The Beovu dose for DME treatment is administered once every 6 weeks, 6 mg (0.05 mL) for the first 5 times, and once every 12 weeks thereafter. Patients with disease activity can be administered once every eight weeks. The administration interval is determined based on disease activity evaluated on vision and/or anatomical criteria. This permission was based on the results of 2 phase 3 clinical trials, KESTREL and KITE, which directly compared the efficacy and safety of the existing treatment, Aflibercept. The clinical trial was conducted on 926 patients with type 1 or type 2 diabetes (566 KESTREL and 360 KITE) aged 18 or older with impaired vision due to diabetic macular edema. In the Beovu medication group, loading dose was administered 5 times every 6 weeks, then administered every 12 weeks, and patients with confirmed disease activity were administered every 8 weeks. The control group was administered 5 times every 4 weeks with loading dos according to the drug's permission and then administered every 8 weeks. At the first year (52 weeks), the median was administered 7 times in the Beovu medication group and 9 times in the control group. The researchers said that existing anti-VEGF treatments that treat DME were usually administered monthly when administering loading dose, making it difficult to improve the patient's treatment burden and resulting symptoms, and based on the results of this study, Blucizumab-dbll will be a new treatment option to reduce the treatment burden for diabetic macular edema. DME is a disease that causes swelling in the macula by increasing vascular endothelial growth factors and proliferating new blood vessels as exudates flow from damaged microvascular vessels due to the inability to control high blood sugar. According to a paper published in 2011, DME is a major disease that causes blindness in adults in developed countries, with 12% of type 1 diabetes patients and 28% of type 2 diabetes patients being affected. Cho Yeon-jin, executive director of Novartis Korea's ophthalmology division, said, "We are pleased to expand treatment options to patients suffering from vision damage following Lucentis with the expansion of indications for the treatment of diabetic macular edema." Executive Director Cho Yeon-jin explained, "Novatis will continue to have leadership in the field of eye disease treatments and make efforts to introduce treatments with efficacy and safety to clinical sites."
- Company
- Why is the exp. date of the Sanofi flu vaccine short?
- by Aug 18, 2022 01:06pm
- With domestic and foreign pharmaceutical companies starting to distribute flu (influenza) vaccines, the expiration date of the Sanofi vaccine is about three months shorter than that of other products. This means that the Sanofi vaccine must be discarded in April, when Korea is still considered to be a flu epidemic period, so it cannot be used. Sanofi explained that it is the best way to speed up the introduction of Korean products. According to the pharmaceutical industry on the 17th, domestic and foreign pharmaceutical companies such as Sanofi, GC Pharma, Boryung Biopharma, Ilyang Pharmaceutical, and Korea Vaccine have started supplying vaccines in preparation for the 2022-2023 seasonal flu epidemic. According to the current status of the seasonal flu vaccine lot release for domestic use released by the Ministry of Food and Drug Safety, a total of 9.32 million people were approved for shipment from July 18 to the 12th of this month. Among them, the expiration date of Sanofi's flu vaccine Vaxigrip is about seven months later, until March 31, 2023, which is particularly shorter than other vaccines. Sanofi received Lot releases for each lot of Vaxigrip on August 1, 2, 4, and 9, which were valid for the same period as March 31 next year. The flu vaccine is usually valid for one year. The validity period of other flu vaccines approved for shipment at the same time is around June-July next year, about a year later. For example, GC Pharma's GC FLU , which received a Lot release on August 1, has an expiration date of June 12, 2023, and Korea Vacine's Kovax-Flu validity period, which was approved on the same day, is June 23, 2023. On August 10, Boryung Bio Pharma's Boryung Flu, which was released on August 10, is specified to expire on July 5, 2023. Ilyang Pharmaceutical Terrestrial Pfs, which received a lot release on July 19, ahead of Sanofi, also has an expiration date of June 14, 2023. This means that the expiration date of Vaxigrip is about three months shorter than that of other flu vaccines, so Vaxigrip must be discarded in April next year, when the flu vaccine is in vogue. In Korea, the flu epidemic is expected from October to April of the following year. The government's national flu vaccination project is also in line with this. The expiration date is not a problem when receiving national shipping approval, but vaccine manufacturers generally distribute vaccines that can be received until the end of the business period. This is because if the expiration date ends within the epidemic period, products that need to be discarded can be inoculated to consumers, and common sense believes that it is inappropriate to supply products that need to be discarded within the business period. Some raise suspicions that the reason why Sanofi supplied the flu vaccine so early is because of the expiration date. Originally, Sanofi distributed the flu vaccine in Korea from September to October every year with GSK. In the case of imported finished products, unlike domestic manufactured vaccines, it takes longer to finish production at foreign factories and enter Korea through a certification process. However, this year, Sanofi began supplying vaccines at the same time as domestic manufacturers. Previously, the expiration date was longer than this, so there was no big difficulty in supplying from September to October, but this year, the expiration date had to be advanced as the expiration date was less than eight months away. An official from a vaccine manufacturer said, "As Sanofi distributes vaccines with a short distribution period in Korea, confusion is expected in the vaccine market," adding, "Some analysts say that Sanofi is accelerating the introduction as it has to quickly exhaust its products this year." Sanofi explained that it brought in products produced relatively early so that domestic consumers could receive vaccines quickly. Unlike previous years, influenza strains that will be prevalent in the southern and northern hemispheres this year were consistent, so there was no need for a technical process to change the strain, which allowed the production of vaccines for the northern hemisphere to be accelerated. Imported finished products have more testing processes and are more difficult than domestic companies, so no matter how fast they speed up, the remaining validity period is bound to be shorter than other domestic vaccines that have been released at the same time. An official from Sanofi said, "Korean corporations have tried to advance the timing due to the late introduction schedule of imported products in Korea, and we have secured vaccines as soon as possible as we can produce Northern Hemisphere products early this year due to the same strain." "The introduction process may be complicated and the expiration date may be relatively short, but we did our best to supply the product at a similar time to other vaccines. Also Vaxigrip Tetra whose expiration date is from May to July 2023 is going to be supplied sequentially in Korea," he said.
- Company
- Yuhan invests ₩23.1B in Yuhan USA over 4 years
- by Chon, Seung-Hyun Aug 18, 2022 05:48am
- Yuhan Corp is making aggressive investments in its US subsidiary. Investing ₩23.1 billion during the past 4 years after establishing Yuhan USA in 2018, the company has been making broad steps to advance into the global market. According to the Financial Supervisory Service on the 17th, Yuhan Corp had invested ₩7.7 billion in Yuhan USA, and acquired 6 million shares in the second quarter of this year. Yuhan USA, which was established in 2018, is the regional subsidiary of Yuhan Corp that is responsible for investing in promising bio-ventures, global clinical trials, and technology exports. As a fully-owned subsidiary of Yuhan Corp, it has been serving as the bridgehead for the company’s global advancement. Yuhan USA has two offices, one in the East, in Boston, and the other in the west, in San Diego. Boston is regarded as the mecca of the global bio-industry, and San Diego is also a rising major bio cluster. An official from Yuhan said, “Yuhan USA has been serving as a bridgehead for the company, strengthening R&D capabilities by quickly acquiring advanced information by engaging in active networking activities in the US for delivery to Yuhan’s Central Research Institute.” Yuhan USA visits local companies, research labs, and universities in the US to directly invest in promising technology and new drug candidates. It also makes indirect investments in bio venture funds in the US and established its own fund to attract local bio-ventures and investors to visit Yuhan USA. The company also directly licensed out Yuhan’s gastroesophageal reflux disease (GERD) treatment in 2020. Yuhan licensed out its GERD treatment candidate 'YH12852' to Processa Pharmaceutical in August 2020 for the exclusive rights to its development, manufacture, and commercialization worldwide, except for Korea. The amount totals a maximum of $408.5 million (₩500 billion). Yuhan had received $2 million of Processa common stock as a non-refundable, non-creditable upfront payment. Processa Pharmaceutical is an R&D specialized company headquartered in Maryland, US that was founded in 2016. Yuhan USA had directly sought technology export partners and conducted negotiations in the US, and made the final deal with Processa Pharmaceutical. Yuhan USA also took part in increasing the possibility of technology exports for Yuhan's new drug candidates by attending major international conferences in the U.S. and introducing their clinical data. At the American Association for Cancer Research (AACR) meeting that was held in April this year, Taewon Yoon, CEO of Yuhan USA, personally attended and presented preclinical data on the company's immuno-oncology drug candidate 'YH32367.' Yuhan had first invested ₩1.9 billion in Yuhan USA upon its establishment in 2018. Since then, the company additionally invested ₩3.5 billion and ₩3.6 billion in 2019 and 2020, respectively, and then ₩6.4 billion last year. With this year’s investment, the total amount sums up to ₩23.1 billion in 4 years. The company is speeding up global market entry by increasing the investment amount every year. Yuhan USA has also been contributing to the development of ‘lasertinib,’ Yuhan’s key technology export project. Yuhan had made a licensing deal with Janssen bBotech for its EGFR targeted therapy ‘lasertinib’ in November 2018. Including the upfront payment of $50 million with no obligation of return, the company will receive a maximum of $1.205 billion under the deal. Yuhan USA is said to be continuously exchanging with its partner Jansen for the commercialization of lasertinib. After making the deal for lasertinib, Janssen has been actively developing the candidate in combination with its self-developed bispecific antibody ‘amivantamab.’ The CHRYSALIS study, the first study initiated by Janssen using lasertinib, is known to be in smooth progress. The study is not only investigating the ‘leclaza+amivantamab’ combination but its combination with platinum-based anticancer therapies such as ‘carboplatin,’ and ‘pemetrexed,’ etc. Yuhan has been making aggressive investments to reinforce the capabilities of its subsidiaries. Yuhan had invested ₩12.3 billion in Yuhan Care since last year. After acquiring 1,469,768 shares of Yuhan Care for ₩5.4 billion, it additionally invested ₩6.9 billion in Q1 this year. Yuhan also invested ₩21.4 billion and ₩0.9 billion last year and this year, respectively, in its IV product subsidiary, MG. The funds Yuhan invested in MG were used for the expansion and improvement of the company’s IV facilities.
- Company
- Sanofi to supply flu vaccine Vaxigrip Tetra Nationwide
- by Aug 17, 2022 05:52am
- Sanofi's Korean subsidiary announced on the 16th that it has supplied its flu vaccine Vaxigrip Tetra nationwide on the 10th to mark this year's flu vaccination season. Sanofi supplied its flu vaccine earlier than usual so that those who need vaccinations can be vaccinated safely and effectively in preparation for the 2022-2023 seasonal flu epidemic. Accordingly, Vaxigrip Tetra can be inoculated at public health centers, consignment medical institutions, and major hospitals and clinics nationwide. Vaxigrip Tetra confirmed immunity and safety profiles through a total of six large-scale global clinical trials (four continents including Europe, Asia, South America, and Oceania) involving more than 13,000 people at all ages, including high-risk groups for influenza such as children, pregnant women, underlying diseases, and the elderly. It is the only quadrivalent flu vaccine that has a vaccination efficacy and safety profile targeting only infants, cardiovascular disease patients, and pregnant women. "With the flu epidemic becoming a reality in southern hemisphere countries such as Australia, the flu epidemic is also feared in Korea," said Woo Jae-kyung, general manager of the Korean company's influenza division. "As the COVID-19 pandemic has not spread over the past two years, natural immunity is likely to be reduced and the flu-sensitive population is more important this season."
- Company
- Will the situation in the Atozet market improve?
- by Kim, Jin-Gu Aug 16, 2022 05:46am
- With the revision of guidelines for treating hyperlipidemia in Korea announced, attention is focused on how it will affect the prescription performance of major drugs. The pharmaceutical industry predicts that the Atorvastatin and Ezetimibe market, which has recently been growing rapidly, will benefit the most from the revision of the guidelines. Domestic pharmaceutical companies that have recently entered this market are also in the midst of preparing marketing and sales strategies with guidelines in mind. ◆ Proactive treatment for patients with high-risk hyperlipidemia According to the pharmaceutical industry on the 9th, The Korean Society of Lipid and Atherosclerosis is planning to officially announce the fifth edition of the "2022 dyslipidemia treatment guidelines" in September. The core of the new guidelines is active treatment for high-risk patients. Patients in stages 1 to 3 of CKD are regarded as high-risk groups and their LDL-C is actively lowered. Currently, the LDL-C level of high-risk patients is lowered to 70, but the revised guidelines lower this target to 50. ◆ The pharmaceutical industry expects Atorvastatin and Ezetimibe to benefit In the case of Ezetimibe, it is expected that its use as a combination therapy with statins will expand in the primary treatment of high-risk patients who are not controlled by Statins alone. In this process, it is predicted that the use of Statin + Ezetimibe will increase. Atorvastatin has a lower burden on the mechanical kidney than other statin drugs such as Rosuvastatin. This is because it is an mechanism of action that is excreted by the liver, not the kidney. Given that the new guidelines see patients with chronic kidney diseases in the first to third stages as high-risk groups, Atorvastatin, which can be used regardless of whether they have kidney disease, is expected to benefit. In the case of Rosuvastatin, as a precaution in use, it is stated in the product manual that do not administer it to patients with severe renal failure. Pitavastatin also includes patients with moderate to severe renal impairment among patients. Atorvastatin and Simvastatin do not include this in the administration indication. ◆Announcement of competitive heating of hyperlipidemia compound, preparing the details that match the guidelines If the guidelines are revised, it is predicted that competition in the Statin+Ezetimibe combination's hyperlipidemia complex market will intensify. According to UBIST, a pharmaceutical market research firm, the performance of Rosuvastatin and Ezetimibe in the first half of the year was 232.9 billion won, up 11.4% from the first half of last year. During the same period, prescription performance of Atorvastatin and Ezetimibe increased 80.6% from 50.3 billion won to 90.8 billion won. The market for Atorvastatin and Ezetimibe is growing explosively with the addition of a large number of generics last year. Until 2020, the Atorvastatin·Ezetimibe combination was one item of Atozet by Organon Korea. Since Chong Kun Dang was approved for Lipilouzet, in October 2020, 113 pharmaceutical companies have entered the Atojet market with generic licenses until June last year. The revision of the guidelines is raising expectations for the growth of the Atorvastatin and Ezetimibe markets. At the same time, it is in the midst of preparing marketing and sales strategies tailored to the revision of guidelines. An official from a pharmaceutical company selling the item said, "We are aware of the revision of the guidelines," adding, "If the guidelines are revised as scheduled, we plan to focus on this part in the second half of the year to further increase prescription performance." Another pharmaceutical company official said, "We expect changes due to the revision of the guidelines to appear first in general hospitals." He explained, "In the local area, we are preparing related details to expand prescriptions tailored to the new guidelines."
- Company
- Wakix, a new narcolepsy drug, can be prescribed at Big 5
- by Eo, Yun-Ho Aug 12, 2022 05:58am
- Wakix, a new narcolepsy drug, can be prescribed at the Big 5 General Hospital. According to the industry, it is Mitsubishi Tanabe Pharma's Wakix recently passed the DC of the Big 5, including Samsung Seoul Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital. Wakix has been on the insurance benefit list since February, forming a confrontation with Nuvigil of Handok Teva. The pay standard for this drug is that in adult patients over the age of 19 who have been confirmed to have narcolepsy, CSF hypocretin-1 immunoreactivity level corresponds to one or more of the patients with hypocretin deficiency measured to be less than 1/3 of the normal level or less than 110 pg/mL. Wakix, a counteracting and antagonist that selectively binds to histamine H3 receptors, is a new mechanism drug that increases histamine concentration in the brain. Nuvigil, an active isomer of sleep seizure treatment Provigil, activates dopamine in the brain to promote awakening and improve the duration of existing drugs. Narcolepsy, a rare and intractable disease, has limited treatment options in Korea. In the United States and Europe, Modafinil, Sodium Oxybate, Solriamfetol, and Pitolisant are used as narcolepsy treatments, but only Modafinil and isomer Armodafinil are permitted in Korea. Narcolepsy is a sleep disorder disease characterized by confusion in the sleep awakening cycle and abnormal expression of REM sleep due to the loss of neurons that produce a neurotransmitter called hypocretin in the brain. Chronic Daytime Sleepiness (EDS) and cataplexy, in which REM sleep is expressed in awakening conditions Cataplexy is known to appear in 70% of narcolepsy patients. Wakix is the first treatment in Korea to be approved for demonstrating clinical efficacy and safety of cataplexy.
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- Verquvo for CHF, aims to enter insurance benefits
- by Eo, Yun-Ho Aug 11, 2022 06:03am
- Verquvo, a new drug for heart failure, aims to enter insurance benefits. dksl According to related industries, Bayer Korea has submitted an application for payment of Verquvo, a water-soluble guanylate cyclase (sGC) promoter that promotes the synthesis of intracellular cyclic Guanosine (cGMP). Verquvo was recently approved in December last year as a combination therapy to reduce the risk of death from cardiovascular disease and hospitalization due to heart failure in patients with symptomatic chronic heart failure, whose left ventricular ejection rate, which experienced intravenous diuretic administration, has decreased to less than 45%. Existing heart failure treatments have been a method of blocking harmful effects from the natural neurohormone system activated by myocardial and vascular dysfunction. Verquvo has a new mechanism to improve myocardial and vascular function by promoting the synthesis of intracellular cyclic monophosphate guanosine (cGMP), which regulates heart contraction, vascular tension, and heart remodeling with a water-soluble sGC stimulant. It was approved as the world's first-in-class chronic heart failure treatment as an sGC promoter. Verquvo demonstrated efficacy through phase 3 clinical VICTORIA The VICTORIA study was conducted in 5, 050 patients with high-risk heart failure with NYHA Class (Grades 2-4) and reduced left ventricular ejection rate to less than 45% who were hospitalized due to heart failure or experienced intravenous diuretic administration outpatient. 59.7% of the patients who participated in the study were undergoing three-drug therapy, and 41% of severely ill patients with NYHA grades 3 and 4. Patients were administered placebo or up to a target maintenance dose of Verquvo 10 mg in combination with other heart failure treatments. As a result, Verquvo had about 10% lower risk of first hospitalization due to cardiovascular disease death or heart failure during 10.8 months (median value) of follow-up, with an annual Absolute Risk Reduction of 4.2%, meeting the primary evaluation variable. The annual absolute risk reduction rate of hospitalization due to heart failure was 3.2%, and as a result of comprehensive evaluation of hospitalization due to death from all causes or heart failure, Verquvo group showed a 10% risk reduction compared to the placebo group. Heart failure is a disease that appears as a final complication of various cardiovascular diseases such as coronary artery disease and high blood pressure without delivering as much oxygen as necessary to the peripheral organs due to structural or functional abnormalities of the heart. Heart failure is a major cause of hospitalization for patients aged 65 or older, and the prevalence of heart failure in Korea has been steadily increasing over the past decade as the population ages. Heart failure is at high risk of worsening over time, and about 50% of patients diagnosed with heart failure have a low survival rate, with death within five years.
- Company
- AKLIEF can be prescribed at general hospitals
- by Eo, Yun-Ho Aug 10, 2022 05:53am
- According to related industries, Galderma Korea's AKLIEF passed the Drug Committee (DC) of higher general hospitals such as Samsung Medical Center and Sinchon Severance Hospital. AKLIEF is a retinoid-based treatment that has been recommended as the primary treatment for acne, and is evaluated as an innovative treatment that can simultaneously treat face and torso acne by overcoming the limitations of existing treatments that have been limited to face acne treatment. Acne is known to occur mainly on the face, but body acne is a common phenomenon. 50% of patients with acne on their faces develop body acne together. According to a clinical study of 965 people, chest and torso acne rates were 45% and 61%, and another study found that about 22% of patients with face and torso acne did not voluntarily report body acne, but more than 75% of those who were offered body acne treatment wanted treatment. Since most treatments have focused on treating facial acne, the reality has been that there has been no appropriate treatment to treat the face and body at the same time. AKLIEF is evaluated as an alternative to overcome the limitations of existing acne treatment. AKLIEF targets retinoic acid receptor gamma (RAR-), the most common RAR on the skin, and is the only large-scale clinical three-phase study to demonstrate efficacy, drug resistance, and safety for face and torso acne. According to PErFEcT1 and 2, a 12-week phase 3 of more than 2,400 people, AKLIEF reduced inflammatory and non-inflammatory lesions quickly from week 1 compared to the control group and effectively decreased body acne from week 2.
