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- 2026-04-07 06:20:58
- Policy
- Was AZ's plan to maintain Forxiga’s drug price all along?
- by Lee, Tak-Sun Jul 19, 2024 05:47am
- With the market withdrawal for the diabetes drug ‘Forxiga Tab,' which retained its insurance price ceiling, already decided upon, AstraZeneca’s decision to withdraw its relevant lawsuit has been gaining much attention. AstraZeneca had filed a lawsuit against the ex-officio reduction in the price of Forxiga and Xigduo that was imposed on May 1 last year upon the emergence of their generics. The lawsuit enabled the company to retain Forxiga’s insurance price. On the 17th, the Ministry of Health and Welfare announced that AstraZeneca had withdrawn its lawsuit filed to cancel the reduction in the insurance ceiling price of Forxiga and Xigduo, ending the lawsuit and lifting the suspension of execution previously made on the price cut for Xigduo. As a result, the price of Xigduo XR 10/1000mg will be reduced from KRW 717 to KRW 512, and Xigduo XR 10/500mg will be reduced from KRW 717 to KRW 473. Dapagliflozin is a diabetes combination drug that contains dapagliflozin and metformin. The price of the single-agent dapagliflozin Forxiga Tab will not be reduced because Forxiga Tab has already been removed from the reimbursement list. Fosiga was removed from the reimbursement list on June 1, following the withdrawal of its domestic marketing authorization on April 25. With its removal, its final insurance ceiling price remains the same at KRW 734. AstraZeneca has made tireless efforts to retain this KRW 734 price. In April last year, when the Ministry of Health and Welfare announced an ex-officio adjustment to its price to KRW 514 due to the introduction of generics, AstraZeneca immediately filed a lawsuit to cancel and suspend the administrative disposition. As the first trial dragged on, the suspension of execution remained in effect. Eventually, the company was able to maintain its KRW 734 price until it was removed from the reimbursement list. Industry officials believe that AstraZeneca defended the price cut in order to sell Forxiga at a higher price in other countries that reference Korea’s drug prices. However, Forxiga almost underwent price cuts not just from ex-officio adjustments but due to post-marketing control measures - the Price-Volume Agreement negotiations. The National Health Insurance Service and AstraZeneca had been in PVA negotiations before June when Forxiga was removed from the reimbursement list. After the first round of negotiations broke down, the parties renegotiated until the end of May, when they decided to leave the price as is without changing the insurance ceiling price. This has led to speculation in the industry that the Ministry of Health and Welfare and AstraZeneca had some sort of agreement within. AstraZeneca would have had to make a counterpayment for the government to allow Forxiga to withdraw from the market at its original price. The news of the litigation withdrawal came a month after Forxiga’s removal from the reimbursement list was finalized. While the price cut of Xigduo was inevitable, AstraZeneca still chose to drop the lawsuit. AstraZeneca could have delayed the price reduction of Xigduo by waiting for the outcome of the first lawsuit. This has led some to speculate that AstraZeneca's withdrawal of the lawsuit was a trade-off for Forxiga’s PVA negotiations. There are also rumors that the Ministry of Health and Welfare was very dissatisfied with AstraZeneca filing the lawsuit. In any case, the withdrawal of the lawsuit reinforces the idea that AstraZeneca's original goal was to maintain the cap on Forxiga, not Xigduo. Unlike Forxiga, Xigduo will continue to be sold in the domestic market. In January, AstraZeneca Korea signed a co-marketing agreement with HK Inno.N for Xigduo. However, some distribution industry insiders have speculated that the company may be abandoning Xigduo as well because of the lack of notification on returns and settlements following the price reduction. However, it seems unlikely that the company would abruptly abandon Xigduo, given how Forxiga has been in the process of market withdrawal for half a year. Last year, Xigduo generated KRW 47.2 billion in outpatient prescriptions, according to UBIST.
- Policy
- MOHW imposes 'CSO Reporting & Training' duty to copromoters
- by Lee, Jeong-Hwan Jul 19, 2024 05:47am
- The government announced on the 18th an amendment to the Enforcement Rules of the Pharmaceutical Affairs Act that imposes the same level of local government reporting and employee training obligations on pharmaceutical companies that have signed co-promotion agreements with drug companies that have obtained the official marketing authorization. Initially, the government considered adjusting the reporting and training obligations for co-marketing pharmaceutical companies to a reasonable level in the amendment to the Enforcement Rules, but ultimately decided it would be difficult to exempt co-marketing pharmaceutical companies from the CSO reporting and education obligations in a subordinate law without changing the parent law, the Pharmaceutical Affairs Act. In order for CSOs to register their business with local governments and perform the contract pharmaceutical sales and promotion services for pharmaceutical companies, the CSO company’s representatives and employees must complete 24 hours of new training. In addition, the employees need to receive 8 hours of refresher training every year from the date of completing the initial training. The training covers order in the distribution of medicines, writing economic benefits and expenditure reports, and CSO compliance. If CSOs file false or fraudulent business reports to the local governments, they will be subject to closure, and if they fail to file a change report or file a false or fraudulent change report, they will be subject to a 3-day business suspension for the first offense, 7 days for the second offense, 15 days for the third offense, and 1 month for the fourth offense. If a CSO engages in drug sales promotion activities using employees who have not received mandatory training, the CSO will be suspended for 15 days for the first offense, 1 month for the second offense, 3 months for the third offense, and 6 months for the fourth offense. On the same day, the Ministry of Health and Welfare made a pre-announcement of legislation on the partial amendments to the Enforcement Rules of the Pharmaceutical Affairs Act and will collect opinions until the 27th. The amendment to the enforcement rules is being promoted to set detailed regulations for the revised Pharmaceutical Affairs Act, which will introduce a CSO reporting system and impose training obligations. The revised Pharmaceutical Affairs Act is scheduled to take effect on October 19th. First, a procedure for reporting new, changes, closure, suspension, and succession of CSO status has been established. CSOs are required to complete 24 hours of new training when registering with local governments to fulfill the notification criteria. Requirements for CSO training and standards for administrative penalties were also established. CSOs are required to receive 24 hours of initial training on the order of drug sales order and 8 hours of refresher training every year starting from the year following the date of initial training completion. The contents of the CSO consignment contract and notification of re-consignment were also stipulated. The amended rule specifies the contents that should be included in the CSO contract, such as the name of the consigned drug, the commission rate for each item, and the matters that require compliance of the consignee and requires written notification to the CSO supplier within 30 days of re-consigning its sales promotion business. The scope of allowable economic benefits has also been clarified. The amended regulation clarified the scope of business activities allowed by drug promoters, such as product presentations, and improved some deficiencies such as by specifying the food and beverage standards that can be provided at product presentations conducted by CSOs at individual nursing institutions. Specifically, in the product presentation category, CSOs are allowed to provide economic benefits within the scope of the law. The previous food and beverage standards at individual care organizations that allowed "food and beverages of KRW 100,000 or less per day (limited to 4 times per month)" were clarified to "food and beverages (excluding taxes and service charges) of KRW 100,000 or less per day, limited to 4 times per month. Meanwhile, from this year, CSOs will also be subject to submit and disclose economic benefit expenditure reports. Active CSOs are required to submit last year's expenditure report to the Health Insurance Review and Assessment Service by the 20th of this month. The implementation of this reporting system is expected to be an opportunity to identify the current status of CSOs in Korea.
- Company
- 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."
- InterView
- ‘We need to actively use acetaminophen ER tablets'
- by Eo, Yun-Ho Jul 18, 2024 05:49am
- Byung-Wook Yoo, Professor of Family Medicine, Soonchunhyang University Seoul Hospital and Young-Jin Kwak, Pharmacist, Raemian Star Pharmacy The use of extended-release formulations is increasing in the field of analgesics. Acetaminophen-based medicines, which consumers commonly regard as cold and fever relievers, are usually given in the form of IR tablets (Immediate Release tablets), which are regular tablets that dissolve quickly in the stomach without any special controlled release technology. On the other hand, extended-release tablets (ER tablets) are designed to release slowly in the body using special controlled release technology. Extended-release tablets are characterized by their longer-lasting effect compared to IR tablets and are convenient because they can be taken less often. Dailypharm met with Byung-Wook Yoo, Professor of Family Medicine, Soonchunhyang University Seoul Hospital, and Young-Jin Kwak, Pharmacist, Raemian Star Pharmacy, to hear about the safety and effect of the less familiar ‘acetaminophen ER tablets.’ ◆Useful for muscle and joint pain as it offers 8 hours of pain relief Studies have already demonstrated that acetaminophen extended-release tablets effectively relieve muscle pain. "In a study that provided acetaminophen extended-release tablets or a placebo to patients who experienced muscle soreness after a marathon, patients who received the extended-release tablets showed significantly higher levels of 'muscle soreness relief' and 'treatment satisfaction' than the placebo group, and significantly lower rates of ‘sleeplessness and sleep disturbance due to pain,’" said Professor Yoo. He added, “In practice, we often see age-related degenerative arthritis patients, many of which take multiple prescription medications. It is necessary to consider acetaminophen as a first-line analgesic in these patients due to concerns over drug interactions.” "The commercially available acetaminophen extended-release tablets are 650 mg in dosages and have a two-layer structure with an immediate-release layer and an extended-release layer. Half of the drug dissolves quickly while the other half dissolves slowly, lasting for 8 hours. Because it provides pain relief over a relatively long period of time, it can be useful for muscle and joint pain, which are often known to linger." ◆What about patients with a weak GI system or the need to take pain medication on an empty stomach? Gastrointestinal side effects are always a concern that accompanies the use of analgesics. Acetaminophen can help in this situation as well. "Acetaminophen has similar analgesic effects to non-steroidal anti-inflammatory drugs (NSAIDs), but with greater gastrointestinal safety and significantly lower side effects," explained Professor Kwak. “NSAIDs, on the other hand, can have problematic GI side effects and are sometimes difficult to use in older patients because of underlying medical conditions and drug interactions from polypharmacy." Kwak added that patients with a weak stomach, related medical conditions, and those taking medications that interact with NSAIDs, such as selective serotonin reuptake inhibitors, may want to first consider the use of acetaminophen. "Pharmacists can assess the patient's situation by asking questions on whether the patient usually has gastrointestinal problems and whether the patient often feels uncomfortable after taking medications, and first consider the use of acetaminophen extended-release tablets, which provide longer-lasting pain relief with fewer gastrointestinal side effects for patients with weak stomachs." "In addition, acetaminophen extended-release tablets are usually taken 3 times daily, usually 1-2 tablets, 8 hours apart, and should not be split, as splitting breaks down the drug’s bilayer structure. Also, care should be taken not to exceed the maximum dose of 4,000 mg (up to a maximum of 6 tablets per day)."
- Policy
- MSD begins cervical cancer trials for its drug candidate
- by Lee, Hye-Kyung Jul 18, 2024 05:48am
- The phase 3 clinical trials for MSD’s new drug candidate 'MK-2870 (sacituzumab tirumotecan)' for the second-line treatment of patients with cervical cancer are being conducted in South Korea. This drug is an antibody-drug conjugate (ADC) currently being studied in multi-national clinical trials for various cancer types, including cervical cancer. On July 16th, the Ministry of Food and Drug Safety (MFDS) approved 'The Phase 3 Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy versus Treatment of Physician's Choice as Second-line Treatment for Participants with Recurrent or Metastatic Cervical Cancer (TroFuse-020/GOG-3101/ENGOT-cx20).' MK-2870 is an ADC for which MSD acquired global rights, excluding China, from Kelun-Biotech. The deal size for this acquisition was US$1.41 billion. It targets TROP-2 (tumor-associated calcium signal transducer 2), which is overexpressed in over 80% of triple-negative breast cancer patients. TROP-2 is associated with growth, transformation, regeneration, and proliferation processes. Notably, in South Korea, 11 clinical trials have been approved, including those recently approved for the treatment of cervical cancer. Phase 3 clinical trials for MK-2870 have been approved since February. The clinical trials are recruiting ▲Patients with endometrial cancer who have previously received platinum-based chemotherapy and immunotherapy ▲Patients with advanced or metastatic non-squamous NSCLC who have previously been treated and have EGFR mutations or other genomic alterations, and ▲Patients with advanced or metastatic esophageal cancer (esophageal adenocarcinoma and esophagogastric junction adenocarcinoma) in third-line or later treatment settings. Since the patent of MSD's leading product, 'Keytruda,' used in cancer immunotherapy, will expire in 2028, MSD is focusing on developing ADC treatments that can substitute for Keytruda. In South Korea, clinical trials for drugs in combination with Keytruda were approved. For instance, the following clinical trials for monotherapies or treatments in combination with Keytruda have been approved: ▲Participants with resectable stage II-IIIB (N2) NSCLC who underwent surgery after platinum-based doublet chemotherapy plus Keytruda adjuvant therapy but did not achieve pathologic complete response (pCR) ▲Participants with EGFR mutation-positive advanced non-squamous NSCLC progressing on prior EGFR tyrosine kinase inhibitor therapy ▲First-line treatment in metastatic NSCLC patients with PD-L1 TPS ≥ 50% using Keytruda combination therapy, and ▲Monotherapy or Keytruda combination therapy in participants with HR+/HER2- inoperable locally advanced or metastatic breast cancer. Meanwhile, global pharmaceutical companies have developed ADCs that have demonstrated effects in various breast cancer types, including triple-negative breast cancer and hormone-positive·HER2-negative breast cancer. ADC is a new anticancer drug that combines an antibody targeting a specific antigen on cancer cell surfaces with a cell death-inducing drug (payload) linked via a linker molecule. ADC has the advantage of increasing treatment effects while minimizing adverse reactions. The drug selectively targets cancer cells using targeted antibody selectivity and cell death-activation.
- 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.
- Opinion
- [Reporter’s view] public-private consultative body
- by Lee, Jeong-Hwan Jul 17, 2024 05:50am
- During the swine flu pandemic, South Korea had a challenging time due to the Tamiflu shortage. Then, during the COVID-19 pandemic, the government spent national finances to import vaccines from the U.S., Europe, and even Russia due to the absence of local mRNA vaccines. During the COVID-19 pandemic, countries worldwide focused on locally distributing medicines and active pharmaceutical ingredients (API), and strengthened the trade hurdle, maintaining a closed economy. Therefore, South Korea acknowledged the importance of the pharmaceutical and biotech industry as a national security industry. The World Health Organization (WHO) announced the end of the COVID-19 pandemic in May of last year. However, the pharmaceutical sector is still affected by its aftermath. There are shortages of basic essential drugs, such as antipyretic analgesic agents containing acetaminophen. Fortunately, the government department responsible for the sector actively meets with a public-private consultative body for drug shortages to resolve the issue. The Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) regularly host meetings with officials from the Health Insurance Review and Assessment Service (HIRA), Korea Pharmaceutical Association, the Korean Medical Association, and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) to review current drug shortages list and possible causes and discuss solutions. Consequently, out-of-stock medicine issues have been resolved with updated policies, such as maintaining production cost and conditional drug price increase, to encourage the volume of production by the pharmaceutical companies that are manufacturing out-of-stock medicines, and administrative measures to simplify the distribution stage. For these effective administrative measures to continue producing positive results, we need to institutionalize them through legislation. In other words, this must be submitted for an item to the National Assembly to specify running a public-private consultative body for drug shortages in the Pharmaceutical Affairs Act. The "public-private consultative body for drug shortages" bill was passed by consensus in the relevant standing committee, the Health and Welfare Committee, in the 21st National Assembly and submitted to the Legislation & Judiciary Committee. However, it was not enacted due to the expiration of the legislative term, resulting in legislative failure. Fortunately, the same bill was reintroduced in the early stages of the 22nd National Assembly and will be considered for review. Drug shortages, which occur frequently and suddenly, disrupt pharmacies and pose a threat to public health. The National Assembly must prioritize and address this pressing national issue with total effort for the well-being of the citizens. Establishing a management committee involving both public and private sectors is crucial to supervising drug shortage distribution and implementing a drug shortage management system. Additionally, legislative measures should ensure the authority to issue emergency production and import orders for drugs in short supply. Establishing this will be essential for effectively addressing drug shortages without delays in an upcoming pandemic. We hope the new National Assembly is aware that the previous legislative term ended without passing this bill, and we hope they will promptly resolve issues through swift legislation.
- 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.
