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- 2025-12-23 00:00:15
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- Efforts to develop a new drug for dry eye syndrome continue
- by Son, Hyung-Min Jul 22, 2024 05:51am
- The domestic and foreign pharmaceutical industry is intent on developing new drugs for dry eye syndrome, making reattempts despite the failure of their clinical trials. Hanall Biopharma is conducting its third Phase III clinical trial, and Huons has started clinical trials with a new drug candidate. In the U.S., Aldeyra is reattempting FDA approval through a new clinical trial after receiving FDA rejection for its previous clinical trial. According to industry sources on the 22nd, Hanall Biopharma recently initiated a Phase III VELOS-4 trial for its dry eye drug HL036 (tanfanercept). The company had previously failed to prove the efficacy of HL036 in two previous trials. The new trial is designed to evaluate the efficacy and safety of HL036 and will enroll 750 dry eye patients at 60 eye hospitals in the United States. HL036 works by inhibiting the tumor necrosis factor (TNF), which causes inflammation in the eye. Results from the VELOS-3 trial, which the company disclosed last year, showed that HL036 did not achieve statistical significance in the primary endpoint of Central Corneal Staining Score (CCSS) and Eye Dryness Score (EDS) at the end of treatment. Specifically, HL036 failed to achieve statistical significance with a CCSS of -0.84 compared with -0.81 in the placebo group. No statistically significant difference was found in EDS as well, being -16.9 in the HL036-treated arm and -19.79 in the placebo arm. However, HL036’s efficacy was confirmed with the Schirmer test, which measures tear volume as a secondary endpoint. Focusing on this efficacy result, Hanall Biopharma aims to secure top-line results for its VELOS-4 trial within the second half of next year. HLB Therapeutics is conducting the 4th trial for its dry eye drug candidate RGN-257 through its US subsidiary, Regentry. Amid the numerous clinical failures, the company has been tirelessly making reattempts, changing the study design again and again. RGN-257 did not meet its primary endpoint in its last published clinical results in 2021. RGN-259 owns a unique mechanism of action that inhibits and modulates pro-inflammatory chemokines and cytokines of thymosin beta 4 and promotes corneal wound healing. HLB Therapeutics plans to complete clinical trials this year and apply for approval next year. Huons recently completed patient recruitment for its Phase III clinical trial to evaluate the efficacy and safety of its HU007 eye drops. In June 2021, Huons voluntarily withdrew its marketing authorization application for HU007 after receiving a data supplemental request from the Ministry of Food and Drug Safety. Following the voluntary withdrawal, the company restarted clinical trials for HU007 in December 2022. The company is also conducting a Phase I clinical trial on HUC1-394, its other drug candidate for dry eye syndrome that has a different mechanism of action. The trial will evaluate the safety, topical tolerability, and pharmacokinetics of HUC1-394 eye drops in gradually escalating doses in 60 adults. HUC1-394 is a peptide-based eye drop that was developed using technology outlicensed from Novacell Technology. The drug candidate is believed to improve keratoconjunctivitis, repairing damaged corneas and reducing inflammation and the likelihood of side effects, which are key factors of dry eye syndrome. US Aldeyra also reattempts approval Aldeyra will restart clinical trials for its dry eye drug candidate, reproxalap. In April, the FDA placed a hold on the approval of reproxalap as a treatment for dry eye syndrome. Aldeyra previously failed to meet its primary endpoint in a Phase III trial in December 2021. Reproxalap is a dry eye drug candidate that targets reactive aldehyde species (RASP). The retrial will enroll approximately 100 patients to assess the primary endpoint of ocular discomfort. In its review, the FDA required Aldeyra to conduct additional clinical trials of dry eye and treatment effectiveness. Aldeyra aims to reapply for approval after conducting additional trials, as it believes it has confirmed the efficacy of reproxalap in improving dry eye symptoms. Based on the clinical results published to date, reproxalap met its primary endpoints of safety and efficacy in 5 clinical trials, including dry eye symptom scores, ocular hyperemia, and Schirmer's test. The company had conducted a range of activities, from within minutes of drug administration to up to 12 weeks of treatment, crossover, and parallel-group clinical trial designs, and assessment in dry eye chamber challenge and natural environment settings, and has found no serious adverse events.
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- The 1st cardiomyopathy drug 'Camzyos' lands in hospitals
- by Eo, Yun-Ho Jul 22, 2024 05:50am
- Product photo of Camzyos (mavacamten). 'Camzyos,' under consideration for insurance reimbursement listing, is becoming available for prescriptions at medical centers. Industry sources said that Bristol Myers Squibb (BMS) Korea's Camzyos (mavacamten), a new drug used to treat obstructive hypertrophic cardiomyopathy (oHCM), has passed the drug committees (DC) of 'Big 5' general hospitals, including Samsung Medical Center, Seoul National University Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital, and approximately 50 medical centers across the country, including Kangwon National University Hospital, Kyungpook National University Hospital, Keimyung University Dongsan Hospital, Pusan National University Hospital, Seoul National University Bundang Hospital, and Chonnam National University Hospital. As a result, it remains to be seen whether Camzyos will be approved for reimbursement listing and actively prescribed. Camzyos has completed the review by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA). It is about to enter drug price negotiations with the National Health Insurance Service (NHIS). Camzyos is the only drug that selectively inhibits cardiac myosin-actin cross-bridge formation, which is the cause of oHCM. Its underlying mechanism involves dissociating myosin from actin, relaxing overstimulated heart muscle, thereby improving left ventricular outflow tract (LVOT) structure and LVOT outflow obstruction. Because no treatments have been available to treat oHCM for a long time, Off-label medications were used to manage symptoms. Last year, when Camzyos emerged, the European Society of Cardiology (ESC) updated its guidelines for managing cardiomyopathy for the first time in about nine years. Previously, the guidelines for HCM were based on evidence limited to small-scale monitoring data, retrospective analysis results, and consensus opinion. However, Camzyos has completely changed this situation. Two large-scale, phase 3 clinical trials conducted as randomized controlled trials (RCT) have confirmed the significant effects of Camzyos. Consequently, ESC guidelines recommend Camzyos with the highest evidence level A for the first time in treatment options. The American College of Cardiology (ACC) and the American Heart Association (AHA) are also preparing to update their guidelines. Furthermore, based on the phase 3 trial evidence, Camzyos was granted a Breakthrough Therapy Designation (BTD) and approval by the U.S. FDA. Considering these factors, Camzyos appears to have met the criteria of an innovative new drug, announced by the government last year: ▲There are no alternative products, therapeutically equivalent products, or therapies available ▲Extending the survival period significantly and showing clinically meaningful improvements ▲Has been approved for MFDS’ GIFT (priority review designation), U.S. FDA’s BTD, or Europe’s EMA expedited review (PRIME). Meanwhile, Phase 3 EXPLORER-HCM study confirmed the efficacy of Camzyos. In the clinical trial, Camzyos was shown to improve primary endpoints, the patient’s symptoms (NYHA classification) and exercise capacity measured with peak oxygen uptake (pVO2), by more than twofold compared to the placebo. Based on the results, 20% of the Camzyos treatment group met NYHA classification and pVO2 improvements. It also reduced the LVOT outflow obstruction index by fourfold after exercise. 10 out of 7 patients who received Camzyos treatment had improved indexes and ended up not considering surgery, and they maintained the effect for 30 weeks.
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- 'Prostate cancer market leader' Astellas eyes on KRW 300 bil
- by Hwang, Byung-woo Jul 19, 2024 05:48am
- Astellas Pharma Korea's sales rebounded within four years due to the sales growth of Xtandi (enzalutamide), a prostate cancer drug. In addition to its leading product, Prograf (tacrolimus), showing strong sales, the company is expected to continue to generate sales growth when Padcev (enfortumab vedotin), an ADC for the treatment of urothelial cancer, become reimbursable. Product photo of Xtandi After sales peaked at KRW 290 billion in 2019, Astellas Pharma Korea experienced a decline to KRW 232.2 billion in 2022 Last year, Astellas Pharma Korea's sales amounted to KRW 251. 1 billion, up 7.5% from KRW 232. 2 billion in 2022. This marks a rebound within 4 years after 2019. The company's sales peaked at KRW 290 billion in 2019, then declined every year with KRW 275.6 billion in 2020, KRW 246.4 billion in 2021, and KRW 232.2 billion in 2022. Astellas Pharma Korea's operational profit in 2019 was KRW 22.3 billion, and it declined to KRW 15.1 billion in 2022. After that, it recovered to KRW 16.7 billion in 2021 and KRW 17.5 billion in 2022. Last year, its operational profit rose to KRW 19 billion. Last year, Astellas Pharma Korea's selling and administrative expenses increased to KRW 80.9 billion from KRW 77.7 billion, up by KRW 13.2 billion. This rise included increased commission expenses (up by KRW 6 billion) and advertising and promotional expenses (up by KRW 2 billion). However, the company increased operating profit due to an overall increase in gross profit. 2019-2023 Astellas Pharma Korea Astellas Pharma Korea's sales growth was brought about by its prostate cancer drug, Xtandi. It is an oral androgen receptor inhibitor (also known as ARTA). Xtandi's sales (according to IQVIA) increased from KRW 43.2 billion in 2023 to KRW 29.1 billion in 2022. Xtandi's sales surpassed Erleada's KRW 15.9 billion and Xtandi's KRW 19 billion during the same period. Such marked growth can be attributed to expanded reimbursement. In August 2022, Xtandi was selectively reimbursed for the treatment of patients with advanced prostate cancer accompanied by distant metastasis when used in combination with androgen deprivation therapy (ADT). Since November of last year, reimbursement has been made regardless of using other androgen synthesis inhibitors. Xtandi is expected to generate further sales growth following expanded indication for the treatment of nonmetastatic, hormone-sensitive prostate cancer (nmHSPC). With this approval, Xtandi has become the only ARTA that can be applied to all stages of prostate cancer stages following biochemical recurrence, including hormone-sensitive, castration-resistant, non-metastatic, and metastatic stages. Prograf maintained KRW 90 billion range in sales for three consecutive years…sales growth expected for Xospata and Padcev While Xtandi has shown significant growth among Astellas products, Prograf, the leading product, has shown a strong presence with sales in the KRW 90 billion range for three consecutive years. Prograf is known for its indications in organ transplantation and immunosuppressive therapy. Generics were launched after the Prograf patent expired in 2005. However, Prograf still maintains over half of the market share in its ingredient segment. Prograf's sales peaked at KRW 90 billion range for the first time in 2021, at KRW 91.5 billion, and it is still maintaining sales, generating KRW 90.6 billion in 2022 and KRW 91.4 billion in 2023. In addition, it continues to expand its presence in the competitive rheumatoid arthritis market. 5 Years Sales Trend of Astellas Pharma KoreaAlthough the increase in sales was modest, the sales of Xospata (gilteritinib), an acute myeloid leukemia treatment, also contributed to the sales growth. Last year, Xospata's sales amounted to KRW 4.8 billion, up 63% from KRW 2.9 billion in 2022. This year's sales are anticipated to increase further due to expanded National Health Insurance criteria in March of last year. Initially, Xospata has been reimbursed with the National Health Insurance as a monotherapy in March 2022. However, it was reimbursed only for patients eligible for allogeneic hematopoietic stem cell transplantation, with a maximum limit of four cycles. However, starting in March of this year, the limitation on eligibility for allogeneic hematopoietic stem cell transplantation and treatment duration have been lifted. As a result, Xospata is reimbursable for all adult patients with FLT3 mutation-positive relapsed/refractory acute myeloid leukemia, in accordance with domestic approval requirements. With the removal of the previous restrictive reimbursement criteria, treatment access is expected to significantly improve for elderly patients who previously could not benefit from the medication and for those who had no treatment option due to ineligibility for allogeneic hematopoietic stem cell transplantation. It is to be watched whether Astellas Pharma Korea will once again reach its previous highest sales of KRW 290 billion in 2019. The pharmaceutical industry anticipates that Padcev, the company's new ADC prostate cancer drug, will drive future growth. In February, Padcev passed the Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA) and has completed the economic evaluation. It remains to be seen when the drug will be considered for the Drug Reimbursement Evaluation Committee (DREC) review. Padcev's sales for last year were only KRW 900 million, but it is already expanding its presence in the global market. When it becomes available with reimbursement, it has the potential to generate steep sales growth.
- Company
- 'Adtralza' lands in general hospitals in KOR
- by Eo, Yun-Ho Jul 19, 2024 05:47am
- Product photo of LEO Pharma Korea’s Adtralza (tralokinumab). 'Adtralza,' the treatment of atopic dermatitis, is quickly establishing presence in the market. Industry sources said that LEO Pharma Korea’s Adtralza (tralokinumab), a treatment for atopic dermatitis with an underlying mechanism of neutralizing interleukin-13 (IL-13), has passed the drug committees (DC) of tertiary general hospitals, including Samsung Medical Center, Seoul National University Hospital, and Seoul St. Mary's Hospital, and other medical centers, including Korean University Ansan Hospital, Boramae Medical Center, Incheon St. Mary's Hospital, and Hanyang University Seoul Hospital. Adtralza was approved for reimbursement listing in May. The reimbursement criteria are set for treating ▲Adult patients (18 years or older) and adolescent patients (12-17 years) with chronic severe atopic dermatitis whose symptoms persisted for over three years, ▲Patients who had topical therapy (moderate corticosteroids or calcineurin inhibitors) as first-line treatment for more than 4 weeks, followed by systemic immunosuppressants for over 3 months, but have not responded well with at least a 50% reduction in Eczema Area and Severity Index (EASI) score or cannot be treated due to side effects, and ▲Patients who achieved over EASI 23 before Adtralza treatment. This drug is a biopharmaceutical that specifically targets IL-13. While Sanofi-aventis Korea’s Dupixent (dupilumab) targets both IL-4 and IL-13, it is difficult to compare the mechanism of actions of the two drugs directly. IL-13 is a crucial cytokine involved in the pathogenesis and symptoms of atopic dermatitis, such as immune response and skin barrier dysfunction. It is known to be overexpressed in atopic dermatitis skin and positively correlated with disease severity. The launch of Adtralza provides a new treatment option for treating atopic dermatitis with a biological agent, in addition to Sanofi's Dupixent, which inhibits IL-4 and 13. The phase 3 ECZTRA3 and ECZTEND studies demonstrated the efficacy and safety of Adtralza. The ECZTRA3 study compared Adtralza to placebo in patients aged 18 years and older with moderate-to-severe atopic dermatitis who had an inadequate response to previous topical therapy or require systemic therapy. The primary endpoints were the percentage of patients who improved their Investigator’s Global Assessment (IGA) score of 0 or 1 at week 16 and those who achieved EASI-75 (a reduction in EASI score of over 75%) improvements. The clinical trial demonstrated a significant improvement with Adtralza, as 56.0% of patients achieved a 75% or greater reduction in EASI score, compared to 35.7% of those receiving a placebo. The results have shown that 38.9% of patients treated with Adtralza improved their IGA score of 0 or 1 at week 16, compared to 26.2% of patients treated with placebo. Dong Hun Lee, Professor in the Department of Dermatology at Seoul National Hospital, said, "Adtralza is a convenient option because patients who achieve clear or improved skin condition after week 16 can be dosed every four weeks at the physician's guidance. In particular, it will reduce the economic burden on patients because the reimbursable price is cheaper than competitors."
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- Forxiga generics, Jardiance·Envlo, surpass original drug
- by Kim, Jin-Gu Jul 18, 2024 05:49am
- (Clockwise from upper left) Product photos of AstraZeneca The market for SGLT-2 inhibitors used to treat diabetes is shifting due to advancing generics and new drugs made in South Korea. The prescription sales of Forxiga (dapagliflozin), which is set to withdraw from South Korea, have significantly dropped. In contrast, the prescription sales of Forxiga generics quickly increased, surpassing those of the original drug in one year since its launch. Similarly, the prescription sales of the new drug in South Korea, 'Envlo (enavogliflozin),' have expanded over sixfold over a year. Analysis suggests that when Forxiga withdraws from the market in the second half of the year, Envlo will likely take second place in the market. 'Set to withdraw from KOR,' Forxiga's prescription sales↓by 26%...generics surpass the original drug According to the medicinal market research firm UBIST on July 17th, Forxiga's out-patient prescription sales in Q2 totaled KRW 10.4 billion, a 26% decrease in a year compared to KRW 14.1 billion in Q2 of last year. Analysis suggests that emerging generics after the patent expiration and the decision to withdraw from the Korean market may have affected Forxiga's prescription sales reduction. The Forxiga patent expired in April of last year. Since then, 65 generics have been launched. In December, AstraZeneca Korea has decided to withdraw Forxiga from the Korean market. The company plans to withdraw Forxiga, a monotherapy drug, and only leave 'Xigduo,' a combination therapy drug containing metformin. Currently, AstraZeneca Korea only provides the existing stock without additional imports from the global headquarters. While the Forxiga sales stalled, generics containing the same ingredient have expanded their market influences. In particular, the Q2 prescription sales of generics surpassed that of the original drug for the first time. In Q2, the prescription sales of 65 Forxiga generics totaled KRW 10.6 billion, a threefold increase from KRW 3.9 billion in Q2 last year. As Forxiga's sales declined in prescription sales, generics sales skyrocketed, resulting in generics turning around. Quarterly prescription sales of the original Forxiga and its generic version (unit: KRW 100 million, source: UBIST). Among the generics, Boryung's 'Trudapa' has recorded the highest prescription performance in Q2, with KRW 1.1 billion, followed by Hanmi Pharm's 'Dapalon (KRW 900 million),' Aju Pharm's 'Dapril (KRW 800 million),' Chong Kun Dang's 'Exiglu (KRW 600 million),' and Kyung Dong Pharma's 'Dapazin'·DongA ST's 'Dapapro'·Daewon Pharmaceutical's 'Dapaone' (KRW 500 million, respectively). The pharmaceutical industry anticipates that the prescription sales of generics will increase more rapidly in the second half of the year. Once the remaining stock of Forxiga starts to deplete, generics are likely to quickly dominate the market. On this note, the industry eyes on HK inno.N’s generic ‘Dapa N.’ Dapa N succeeded Forxiga's heart failure and kidney disease indications. In April, AstraZeneca announced that they would withdraw the BLA of Forxiga and transfer Forxiga's heart failure and kidney disease indications by granting clinical documents. As a result, Dapa N became the only generic product that gained the indication of the original drug. The industry expects the drug to start experiencing indication advantage in the second half of the year. The sales of Envlo, a new drug in South Korea, have increased 5.6 fold over a year…Jardiance has been the market leader for a year The prescription sales of Boehringer Ingelheim's Jardiance (empagliflozin) and Daewoong Pharmaceutical's Envlo have increased. It seems that the expected withdrawal of Forxiga from the Korean market may have partially influenced this trend. Jardiance has been the market leader since Q2 last year when the Forxiga patent expired. Since then, its prescription sales have been continuously increased. Jardiance's prescription sales for this Q2 totaled KRW 16.1 billion, up 10% YoY from KRW 14.6 billion. The 36th new drug in Korea, Envlo, is also quickly expanding prescription sales after its launch in May last year. The Q2 prescription sales of Envlo amounted to KRW 2.5 billion, an increase of 5.8-fold compared to KRW 400 million YoY. Summing together with HanAll Biopharma’s 'Eaglex' and Daewoong Pharmaceutical's 'Benavo,' both of which were launched at the time of Envlo, the prescription sales of these generics increased from KRW 500 million to KRW 2.8 billion over a year, an increase by 5.6-fold. Prescription sales of SGLT-2 inhibitors used to treat diabetes: Forxiga, Forxiga generics, Jardiance, Envlo, Suglat, and Steglatro (unit: KRW 100 million, source: UBIST). The industry expects Envlo's sales to continue increasing after this year. It seems that Envlo is expected to become the no.2 in the market for SGLT-2 inhibitor monotherapy, surpassing Forxiga within this year as the prescription sales of Forxiga are expected to decline quickly. Meanwhile, the sales of Astellas Pharma's 'Suglat (ipragliflozin)' and MSD's 'Steglatro (ertugliflozin)' continued to stall for a long time. Over a year, the prescription sales of Suglat declined from KRW 1 billion to KRW 900 million, and that of Steglatro declined from KRW 300 million to KRW 100 million. These companies have decided to withdraw from the market due to low sales. Generics' sales are increasing in the market for combination therapies…over a year, KRW 2.1 billion→KRW 6.4 billion The sales of generics are increasing in the market for combination therapies containing SGLT-2 inhibitor and metformin. In Q2, the prescription sales of 35 products that are generic versions of Xigduo (dapagliflozin+metformin) totaled KRW 6.4 billion. This figure marked an over threefold increase from KRW 2.1 billion in Q2 last year. Boryung's 'Trudapa M' and Hanmi Pharm's 'Dapalon Duo' recorded KRW 1.1 billion, followed by Aju Pharms' 'Dapril Duo'·Kyung Dong Pharma's 'Dapamet' (KRW 800 million, respectively), and Daewon Pharmaceutical's 'Dapawon-M' (KRW 500 million). However, 20 other companies manufacturing generics recorded the prescription sales below KRW 100 million in Q2. AstraZeneca's Xigduo remains the no.1 in the market for combination therapies, with KRW 10.4 billion in prescription sales. However, sales were reduced by 15% from KRW 12.2 billion in Q2 last year. The industry anticipates a significant reduction in Xigduo's prescription sales in the second half of this year due to a price reduction next month. The price reduction was delayed at AstraZeneca's request for execution suspension. The prescription sales of Boehringer Ingelheim's 'Jardiance Duo (empagliflozin+metformin)' saw a 4% increase from KRW 9.9 billion in Q2 last year to KRW 10.2 billion. 'Envlomet (enavogliflozin+metformin)' recorded KRW 400 million in prescription sales in Q2 this year. Daewoong Pharmaceutical launched Envlomet in November last year.
- Company
- GSK challenges Meningococcal serogroup B mkt with Bexsero
- by Hwang, Byung-woo Jul 18, 2024 05:49am
- GSK and Sanofi, the leading meningococcal vaccine companies in Korea, are set to face new competition with the approval of their next-generation vaccines. GSK Korea plans to gain competitivity with Bexsero, which has strengths in protecting against serogroup B, which accounts for the largest share of meningococcal infections in Korea since 2010. #1 GSK Korea held a press conference to celebrate the launch of Bexsero, the first meningococcal serogroup B vaccine in Korea, and discussed the current status of meningococcal B outbreaks and the effectiveness of its vaccine. Meningococcal infections can cause invasive meningococcal infections, meningitis, and sepsis. Invasive meningococcal infection progresses rapidly and can cause death within 24 to 48 hours of the onset of symptoms. Even with treatment, the disease is deadly, with a fatality rate of 8-15%. "Globally, meningococcal infections are most prevalent in infants under one year of age compared to other age groups,” explained Hyun-Mi Kang, Professor of Pediatrics, Seoul St.Mary’s Hospital, who made a presentation at the event, “It causes bacterial meningitis and sepsis, and one to two out of 10 survivor also experience brain damage, hearing loss, and limb loss.” Typical serogroups of meningococci that cause invasive meningococcal infections in humans include A, B, C, W, X, and Y. The most predominant meningococcal serogroup in Korea, the United States, and Europe is serogroup B, with high levels found in infancy and adolescence. From 2010 to 2016, the proportion of meningococcal B serogroup cases identified in Korea was 28%, but from 2017 to 2020, the rate increased significantly to 78%. "The prevalence of meningococcal serogroups varies across countries and time periods, so it is not easy to predict," said Professor Kang. "In Korea, the serogroup B meningococcal infection cases has increased in recent years, increasing the need for its prevention.” GSK had launched Bexsero to address this situation in Korea. "The predominance of meningococcal B in Korea has made it necessary for us to introduce a vaccine to prevent infections caused by meningococcal B," said Dr. Joon Bang, Director of Medical Affairs at GSK Korea. Meningococcal B's capsular polysaccharide is structurally similar to human tissue, which has made vaccine development challenging due to the risk of autoimmune damage. GSK developed Bexsero by applying novel technologies that employ genome sequencing. Since its initial European approval in 2013, GSK has accumulated over a decade of experience in preventing meningococcal B infections, conducting 17 studies on subjects aged 2 months to adults. The most predominant meningococcal serogroup in Korea, the United States, and Europe is serogroup B. However, meningococcal vaccines are not mandatory and are being administered without reimbursement, which means that patient opinions, pharmaceutical company strategies, and pricing influence market competition. With GSK's Menveo and Sanofi's Menactra currently available in the market, the launch price of Bexserois also an area of keen interest. "Bexsero is not intended as a replacement to Menveo; the scope of prevention offered by the two vaccines are different," said Hyunji Kwon, Head of GSK's Vaccine Business Unit in Korea. "We cannot give a specific number because the price of Bexsero is set after a comprehensive review of the vaccine's functions, efficacy, and value."
- Company
- Organon introduces JADA system for postpartum hemorrhage
- by Hwang, Byung-woo Jul 18, 2024 05:48am
- Organon, which emphasizes its focus on women's health after spinning off from MSD, has launched its first product in Korea. The JADA system (JADA), a medical device for the control and treatment of postpartum hemorrhage, is the first product the company released in Korea since Organon officially launched its Korean subsidiary in June 2021. JADA, which can be used for intrauterine negative pressure hemostasis, was recognized as a safe and effective new health technology by the National Evidence-based Healthcare Collaborating Agency (NECA) late last month. For Organon, the approval of JADA is significant because it is the first new product the company has introduced in Korea since the spin-off. Since its launch, the company has been differentiating itself by providing solutions focused on women's health, and the JADA aligns with the company’s purpose. Among Organon's many solutions at the global level, the company chose to first introduce the JADA system to Korea to address the unmet need for postpartum hemorrhage. According to Organon, postpartum hemorrhage is one of the most common birth complications, but can even result in maternal death. According to a national survey conducted from 2009 to 2014, about one-fifth of all mothers experience postpartum hemorrhage. In other words, the introduction of the JADA system has significance because it provides a new treatment option that can quickly and accurately control postpartum hemorrhage, which is of high concern amid the declining birthrate and rising interest in maternal health. "JADA is the first fruit born through Organon's efforts to deliver new treatment options for unmet needs in women's health since its inception," said So Eun Kim, Managing Director of Organon Korea. "We will continue to lead the way in providing various innovative medicines and solutions that address the health challenges that women may face throughout their lifecycles." Product photo of the JADA system and a schematic diagram of its mechanism of action JADA is the first new technology introduced in 15 years since the introduction of the intrauterine balloon tamponade and compression suture. While conventional intrauterine balloon tamponade systems achieved hemostasis by applying direct pressure to the lining of the uterus for 12 to 24 hours, JADA creates a negative pressure state in the uterus within minutes and applies pressure (up to 90 mmHg) to induce physiologic contractions. In the PEARLE study, bleeding was controlled successfully with JADA in 94% of the participants without requiring further interventions, with a median time to control bleeding of 3 minutes. Since its U.S. Food and Drug Administration (FDA) approval in August 2020, JADA has been expanding its reach in Asia including Hong Kong and Singapore, as well as parts of the Middle East and South America. "As the risk of postpartum hemorrhage increases in line with an increase in the mother's age, the importance of controlling postpartum hemorrhage for healthy births will continue to increase," said an Organon representative. "We are working to launch JADA in Korea, but the official launch date has not been set yet." The representative added, “Organon Korea has identified a number of unmet needs in women's health and will continue to strive to provide a range of innovative medicines and solutions for various health issues that women may experience throughout their lifecycle."
- Company
- ProGen expands bi-specific antibody R&D with Korean partners
- by Son, Hyung-Min Jul 17, 2024 05:50am
- ProGen's R&D competitiveness in developing bi-specific antibodies expands to various fields, including immunotherapy, diabetes drugs, and new drugs for obesity. ProGen has started joint research with Yuhan Corp. to develop immunotherapy, and the company has also entered phase 2 trials for in-house developed drugs for diabetes and new drugs for obesity. Furthermore, ProGen has signed a business agreement with AbTis, a subsidiary of Dong-A ST, to develop bi-specific antibody-drug conjugates (ADC). Sources said on July 16th that earlier this month, ProGen signed a comprehensive R&D collaboration agreement with Yuhan Corp. to develop innovative new drug candidates. These companies have established a new drug development committee comprising new drug development experts, and they are set to develop next-generation new drugs and strengthen global market competitiveness. Under this agreement, ProGen and Yuhan Corp. plan to develop bi-specific antibody-mediated immunotherapy. These companies are currently developing PG-208, which is in the candidate product search stage. ProGen specializes in developing bi-specific antibodies, and the company has a proprietary 'NTIG' platform, which is a long-term fusion protein technology. The NTIG platform has the advantage of improving the half-life of proteins in various forms and administration intervals. The NTIG is optimized for the development of anti-cancer and immune disease treatments with multi-targeting and long-term durability. ProGen Progen also has another platform called 'Cyt-NTIG,' which combines NTIF platform technology and proprietary engineered cytokine. This platform targets cytokines that induce immune overactivation, overcoming systemic side effects of cytokines. Cytokines are proteins involved in immunity and inflammation, including the cell's proliferation, cell division, cell death, and wound healing. ProGen is investigating various possibilities with this bi-specific platform technology. In addition to developing immunotherapy, the company is investigating the potential of bi-specific antibodies in treating ADC, obesity, and diabetes. In April, ProGen signed a collaboration agreement with AbTis, a subsidiary of Dong-A ST, to develop bi-specific antibody-mediated ADC. AbTis plans to develop bi-specific antibody-mediated ADC by combining its third-generation ADC linker technology, 'AbClick,' which overcomes conventional ADC limitations, with ProGen's NTIG technology. ProGen and AbTis aim to develop new drugs for autoimmune diseases by working on new bi-specific antibody-drug conjugates (BsADC) for immune diseases. ProGen Developing bi-specific antibodies for diabetes and obesity ProGen is also developing bi-specific antibodies for diabetes and obesity. ProGen is developing PG-102, an obesity treatment that targets GLP-1 and GLP-2 bi-specifically. The Ministry of Food and Drug Safety (MFDS) recently approved a phase 2 trial in South Korea for this new drug candidate. The phase 2 trial will evaluate the safety and efficacy of PG-102 and placebo in patients with diabetes and obesity. GLP-1 is the incretin hormone secreted from the intestine, increasing glucose-induced insulin secretion. It is known to play an important role in regulating weight control. ProGen aims to maximize the effects, such as improving intestine function, glucose uptake in adipose tissue, and alleviating chronic inflammation, by targeting both GLP-1 and GLP-2. In a preclinical trial, PG-102 demonstrated more significant weight loss effects than tirzepatitide, the ingredient used in Zepbound. In detail, PG-102 improved the metabolic function in a mouse model of diabetes and obesity and demonstrated effective weight loss results in adipose cells. In the phase 1a trial involving healthy individuals, PG-102's safety and drug tolerance have been confirmed. When the effects of PG-102 on blood glucose and weight loss are confirmed through local phase 2 trials, ProGen aims to enter global phase 2 trials next year. Additionally, ProGen is collaborating with Rani Therapeutics, a United States-based company, to jointly develop the oral obesity drug, RPG-102. RPG-102 contains PG-102 in Rani Therapeutics' oral RaniPill capsule. The recently disclosed phase 1a trial results confirm RPG-102's drug tolerance and safety results. ProGen and Rani Therapeutics plan to develop RPG-102 as a once-weekly oral therapy.
- Company
- Botulinum toxin exports in 1H rise 17%
- by Kim, Jin-Gu Jul 17, 2024 05:50am
- Korea's botulinum toxin exports increased by 17% year-on-year in the first half of this year. This is the highest half-yearly export performance recorded ever. The increase in exports to the United States, China, and Japan is analyzed to have driven the increase in overall botulinum toxin exports. According to the Korea Customs Service on July 16, the amount of domestic botulinum toxin exports from January to June this year was USD 194.21 million (about KRW 270 billion). Compared to the USD 166.39 million recorded in the first half of last year, the amount has increased by 17% in just one year. This is the highest half-year export record ever. In the last three years, botulinum toxin exports have steadily increased, since recording USD 122.1 million in the first half of 2021 and USD 127.91 million in the second half; USD 131.41 million in the first half of 2022, and USD 164.9 million in second half; USD 166.39 million in the first half of 2023 and USD 186.62 million in the second half; and USD 194.21 million in the first half of this year. The industry is expecting to exceed the USD 200 million mark in the second half of the year. Semiannual exports of Korean botulinum toxins (Unit: USD 1 million, Source: Korea Customs Service) By country, exports to the United States, China, and Japan increased significantly. In the first half of the year, exports to the U.S. totaled at KRW 35.64 million, up 55% from the USD 23.01 million in the same period last year. Exports to China increased 53% from USD 23.55 million to USD 35.92 million. Exports to Japan increased 45% from USD 10.52 million to USD 15.27 million. Thailand and Brazil, which had been 2 of the leading exporting countries for domestically produced botulinum toxin, saw a slowdown. Exports to Thailand increased only 3%, from USD 14.01 million to USD 14.37 million. Brazil's exports dropped 25% from USD 21.07 million to USD 15.81 million. The industry expects a further increase in exports of domestic botulinum toxin products to the US and China markets in the future. In the US, Daewoong Pharmaceutical's Jubo (domestic product name: Nabota) has entered the market. The company has been selling its product through its local partner Evolus. Last year, Daewoong Pharmaceutical's botulinum toxin exports were estimated to be KRW 109.9 billion, with most coming from the US. 대웅제약 주보(좌), 휴젤 레티보 제품사진. Hugel is also preparing to enter the US market. In March this year, the company received the U.S. Food and Drug Administration's (FDA) approval for Retivo (domestic product name: Botulax). It is the second domestic botulinum toxin after Daewoong Pharmaceutical's ZuboJubo to receive marketing authorization in the US. In June, the company won a strain dispute with Medytox and overcame the biggest obstacle to entering the US market. The U.S. International Trade Commission (ITC) issued a preliminary ruling that Hugel did not infringe on Medytox's intellectual property rights. If this preliminary ruling leads to a final ruling in October, it is expected to accelerate Retivo's entry into the U.S. market. Hugel’s Retivo entered first in the Chinese market. Hugel received marketing authorization for Retivo in China in October 2020. Since then, it has reportedly been steadily increasing exports. Daewoong Pharmaceutical is also accelerating its entry into China with Nabota. Daewoong has applied for Nabota’s approval in China. Daewoong plans to launch Nabota in China early next year after receiving marketing authorization within the year. In addition to Daewoong, Huons is also in the process of applying for marketing authorization for its product to enter the Chinese market.
- Company
- Ultomiris gets expanded indication for neuromyelitis optica
- by Hwang, Byung-woo Jul 17, 2024 05:50am
- Ultomiris (ravulizumab) has strengthened its position in the market for neuromyelitis optica after obtaining approval for expanded indication. Product photo of UltomirisOn July 11th, the Ministry of Food and Drug Safety (MFDS) granted approval of expanded indication for Ultomiris, a C5 complement inhibitor, for the treatment of adults aged 18 years and above with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP-4) antibody-positive. The approval of NMOSD indication was based on data from the external placebo-controlled, multi-center, open-label phase 3 CHAMPION-NMOSD trial, which evaluated the treatment effect and safety of Ultomiris. The placebo used in the control group was the placebo from Soliris’ phase 3 PREVENT trial for NMOSD, considering that NMOSD is a rare disease and Ultomiris and Soliris are similar treatment types. The data from the 73-week (median treatment period) clinical trial demonstrated that patients who received Ultomiris were recurrence-free and had a 98.7% reduction in the risk of recurrence compared to those who received placebo. Furthermore, the research confirmed a significant improvement in the secondary endpoints, annual recurrence rate (APR) and the Hauser Ambulatory Index (HAI). During the clinical trial, there were no cases with recurrence when treated with Ultomiris, recording 0.000 APR. It was reported that the rate of patients who experienced worsened HAI in Ultomiris was 3.4% (2 out of 58), whereas those who received placebo had a 23.4% HAI (11 out of 47). Additionally, the trial had three severe adverse cases after the start of treatment. Two patients had meningococcal infections but continued treatments after recovery without any side effects. Ho Jin Kim, Professor of the Neurology department at the National Cancer Center, said, “Ultomiris demonstrated no recurrences in NMOSD patients for 73.5 weeks. It is a treatment option with improved convenience of treatment, as it extends the duration interval from 2 weeks to 8 weeks.” Ultomiris is the next-generation C5 complement inhibitor, as it extended its half-life by four times compared to Soliris. Soliris required administration every two weeks, whereas Ultomiris improved the convenience of treatment by extending the interval to 8 weeks. “The interval of treatment not only reduces the number of hospital visits, but also saves the physical strength of patients with difficulties in walking and vision. It also reduces other costs related to hospital visits,” Kim added. “Improvements of convenience alleviate the burden of treatment and help improve patients’ quality of life and treatment compliance,” Kim explained. With the current indication approval, Ultomiris can be used to treat four rare diseases, including ▲paroxysmal nocturnal hemoglobinuria (PNH) ▲atypical hemolytic uremic syndrome (aHUS), and ▲generalized myasthenia gravis (gMG). Chul Woong Kim, Lead for Rare Diseases at AstraZeneca Korea, said, “After obtaining reimbursement approval for Soliris, we are pleased to contribute to the improvement of NMOSD treatment in South Korea with the expanded indication for Ultomiris.” Kim added, “We will strive to enhance treatment options so that more NMOSD patients can receive treatments without fear of recurrence and continue with their daily lives.”
