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- 2026-04-07 09:51:39
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- 92 patient groups implore doctors to stop the strike
- by Kang Hye-Kyung Jun 14, 2024 05:46am
- “We strongly demand the doctors withdraw their resolutions to take a collective leave of absence and indefinite leave of absence as they threaten the patients' lives and health." Ninety-two patient advocacy organizations have called for the withdrawal of the medical community's collective strike that is set to start on the 18th. Ninety-two patient advocacy organizations, including the Severe Atopic Dermatitis Association, the Union of Korea Breast Cancer Patients, the Korean Alliance of Patients Organization, and the Korean Organization for Rare Diseases, held a press conference in front of the main gate of the National Assembly on the morning of the 13th to criticize the medical community's plans for a collective leave of absence. The PAGs said, "We are deeply concerned about the Korean Medical Association's collective leave of absence and the indefinite leave resolution of the Seoul National University College of Medicine and Seoul National University Hospital Faculty Council. We strongly demand that they withdraw the collective leave of absence and indefinite leave resolutions that threaten the lives and health of patients.” "Over the past four months, patients have suffered great anxiety and harm due to the prolonged medical gap caused by the collective action of doctors. We are devastated to see another collective strike launched at a time when we are just beginning to see hope for solving the situation." The PAGs called on the government and the National Assembly to enact relevant systems and laws to prevent the recurrence of collective actions by doctors.
- Company
- Industry concern rises over the spread of the medical strike
- by Kim, Jin-Gu Jun 14, 2024 05:46am
- Some large hospitals are restricting access to pharmaceutical company employees’ access in the wake of a medical gap created by their resident doctors’ leave of absence. The pharmaceutical industry's situation worsens as the medical community is threatening to take a collective leave of absence due to conflict with the government over increasing medical school admissions. There are voices that say if the leave of absence, which is being made by doctors and some medical professors, spreads throughout the medical community, it will inevitably affect the industry’s Q2 performance results. There are already reports of companies predicting operating losses for their second quarter and some entering a state of emergency management. Medical representatives (MRs) in charge of general hospitals are on the verge of nervous breakdown, being unable to meet with medical professors. Pharma industry closely monitors the development of the medical strike ..." de facto emergency management system in place" According to industry sources on the 13th, the Korean Medical Association will take a collective leave of absence on the 18th. The association also announced a general strike at Yeouido Park in Seoul. In addition to the Big 5 hospitals, an increasing number of university hospitals have announced their participation in the strike. The faculty council of Seoul National University Hospital and Seoul National University Bundang Hospital decided to take a complete leave of absence on the 17th. Doctors at Severance Hospital will also take an indefinite leave of absence from the 27th. The Samsung Medical Center has also joined the collective leave of action, with other large hospitals also discussing plans. The medical strike, which had been ongoing amongst doctors and some medical school professors, seems to be spreading to large hospitals and clinics. The pharmaceutical industry is also watching the situation closely. Industry insiders say that if the medical community continues to take a leave of absence, the move will inevitably hurt the industry’s second-quarter earnings. Some companies are already forecasting losses for the second quarter and have effectively gone into emergency management. "Since last week, meetings involving executives from all departments have been held frequently," said an official from a large pharmaceutical company, "and it has been concluded that the company’s Q2 results will fall far short of the original target. We are currently discussing ways to minimize the damage." An official from another pharmaceutical company said, "If you look at our results through May, we're looking at a loss for the second quarter. The problem is that we don't have a good way to make up for it. We are keeping a close eye on the situation in the healthcare industry." An MR in charge of general hospitals confesses, "I haven't done anything for 2 months," The departments in charge of sales and marketing are also concerned about the spread of the medical strike. Departments that have launched or are planning to launch new products are said to be particularly affected by the prolonged medical-government conflict. An official from the marketing department of a domestic pharmaceutical company that recently launched a new product said, "Companies with existing products that have a high market share may not have a big problem, but companies that are planning to launch new drugs or new products are facing difficulties. We originally planned a large-scale launch symposium, but it has now been postponed indefinitely." The official added, "Recently, many medications are being prescribed in the long-term, for 6 months, making it very difficult for new drugs to be prescribed. This is a big risk for new drug sales and marketing teams." For departments related to general hospitals, the situation is worse as the MRs in charge could not meet with their medical professors since the start of the strike at the beginning of the year. Some surgeons and residents have returned to work, but in the internal medicine department, most full-time doctors and residents have not returned, with faculty members on call 2-3 times a week in rotation. An MR from a domestic pharmaceutical company in charge of a general hospital in Daejeon said, "I haven't worked since last month. Before that, I was at least receiving training, but now I am doing nothing. The company is just telling me to wait and see what happens. I don't want to force meetings with professors because it could backfire." An official in charge of clinical affairs at a multinational pharmaceutical company said, "It is also difficult to enroll patients in global late-stage clinical trials. Doctors are reluctant to attend even when we offer meetings to encourage participation in multicenter investigator-initiated trials (IITs). There are many restrictions to them attending not only investigator meetings but also pharmaceutical company events held in the evening or on weekends."
- Policy
- Drug pricing negotiations complete for Idelvion in KOR
- by Lee, Tak-Sun Jun 13, 2024 05:48am
- The hemophilia B treatment Idelvion is soon expected to be reimbursed in Korea, with CSL Behring completing drug pricing negotiations for the drug with the regulatory authorities. The drug’s advantage is in its convenience in administration, as it can be administered once every 1 to 3 weeks. According to industry sources on the 12th, the National Health Insurance Service recently disclosed that it has completed drug pricing negotiations for Idelvion. The NHIS has been disclosing its drug pricing negotiation results since April. Idelvion Inj had been in drug price negotiations since April after passing the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review in March. CSL Behring received domestic approval for Idelvion in March 2020 and has been pursuing reimbursement since then. In July 2021, DREC gave a conditional pass, deeming that reimbursement is adequate if the company accepts a price below the assessed amount, but the conditional pass did not lead to negotiations with the NHIS at the time. The company then aligned its strategy and applied to receive DREC review the second time, and in March, it was deemed adequate for reimbursement and received unconditional approval. The drug is indicated for the ▲control and prevention of bleeding episodes, ▲ control and prevention of bleeding in the perioperative setting, and ▲ routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia B (congenital factor IX deficiency). Hemophilia B is a congenital bleeding disorder caused by a single gene defect and is caused by a deficiency in coagulation factor IX (blood coagulation factor 9), a protein that helps blood coagulation and is mainly produced in the liver. Hemophilia B accounts for about 20% of all hemophilia patients. Pfizer’s ‘BeneFIX Inj’ is the top-selling product in Korea’s hemophilia B treatment market. According to IQVIA, BeneFIX sold KRW 7.2 billion’s worth last year. Hemophilia B is treated using intravenous injection to supplement the missing clotting factor. BeneFIX’s advantage was in its convenience in administration, being able to be injected once weekly. Idelvion also has an advantage in its convenience in administration. Its recommended dose is 35 to 50 IU/kg once weekly for routine prophylaxis. Patients aged 12 years or older who are well-controlled on once weekly dosing regimen may switch to 10 to 14-day interval regimen of 75IU/kg. Also, patients aged 18 years or older who are well controlled with the 14-day regimen for at least 6 months may receive 100 IU/kg every 21 days. The extended dosing interval, administered once weekly to up to every three weeks, is expected to improve convenience in dosing and quality of life for patients. If Idelvion is reimbursed, the Australian pharmaceutical company CSL Behring will own treatments for both hemophilia A and B in the country. CSL Behring also owns the rights to ‘Afstyla,’ a single-chain recombinant factor VIII for hemophilia A that was developed and licensed-out by SK Chemicals. Afstyla has been reimbursed in Korea since May 2021.
- Company
- The first APDS drug 'Joenja' gets orphan drug status in KOR
- by Eo, Yun-Ho Jun 13, 2024 05:48am
- Pharming Group A rare disease treatment 'Joenja' has received orphan drug designation in South Korea. The Ministry of Food and Drug Safety (MFDS) states this through the report on the designation of Orphan Drugs. Joenja (leniolisib), developed by the Dutch company Pharming group, is the first treatment for activated phosphoinositide 3-kinase delta syndrome (APDS). The drug was approved by the U.S. Food and Drug Administration (FDA) in March of last year. APDS is caused by a mutation in either the PIK3CD or PIK3R1 gene, essential to immune cell development and function. It occurs in 1 per 1-2 million. APDS patients commonly develop autoimmunity and inflammatory symptoms. They may suffer from ear, paranasal, and upper and lower respiratory infections. Moreover, APDS patients are susceptible to swollen lymph nodes and enlarged spleen, as well as an increased risk of cancer, such as lymphoma. Joenja’s approval was based on results from a multinational, triple-blind, placebo-controlled, randomized phase 2/3 clinical trial evaluating the efficacy and safety of the drug in 31 patients with APDS aged 12 years and older. Open label extension data of 38 patients receiving Joenja for an average of two years were also submitted. Randomized and placebo-controlled clinical results at 12 weeks demonstrated the clinical effects of Joenja 70 mg administered twice daily. It obtained a significant finding from the co-primary endpoints, which evaluated lymphoproliferation as measured by the reduction in lymph node size and increase in naïve B cells. It reflected the impact on immune dysregulation and normalization of immunophenotype. The change between Joenja and placebo for lymph node size was –0.25, and for the percentage of naïve B cells was 37.30. The most common adverse reactions were headache, sinusitis, and atopic dermatitis. Meanwhile, Pharming Group signed a license agreement with Novartis for Joenja in 2019. Novartis received US$10.5 million from Pharming Group when Joenja launched in the United States in April last year, as well as additional milestone and recurring royalty revenue.
- Policy
- "Chickenpox vaccine 'Sky Varicella Inj' is safe…"
- by Lee, Jeong-Hwan Jun 13, 2024 05:48am
- SK Chemical’s varicella virus vaccine, Sky Varicella Inj. The Korea Disease Control and Prevention Agency (KDCA) reported on June 12th that experts and related agencies have conducted an investigation and analysis in response to an increased number of adverse reactions reported following vaccination with 'Sky Varicella Inj,' a varicella virus vaccine, and they confirmed that there are no safety concerns related to the vaccine. According to the KDCA, cases of shingles have been recently reported following vaccination with Sky Varicella Inj. From 2018 until May this year, 1,888,631 varicella virus vaccinations were given, and 29 cases of shingles were reported after the vaccination (reported rate: 0.0015%). The reported rate of shingles after vaccination with SK Chemical’s varicella virus vaccine, Sky Varicella Inj, was 0.003%. Consequently, the KDCA formed a public-private working group on April 26th following the decision by the Korea Expert Committee on Immunization Practices (KECIP). The group conducted a comprehensive review, including the safety of the varicella virus vaccine and shingles cases after vaccination, and concluded that there are no safety concerns related to Sky Varicella Inj. The public-private working group consisted of three pediatric infection experts, one virus experts, pharmacoepidemiology expert, and officials from the National Health Insurance Service (NHIS), KDCA, and the Ministry of Food and Drug Safety (MFDS). The MFDS stated it had conducted a comprehensive evaluation of documents related to quality and non-clinical·clinical trials submitted during the approval of the varicella virus vaccine, reports of national lot release at every manufacturing stage, and cases of adverse reactions reported in South Korea and oversees. The findings indicated no safety concerns related to the vaccine itself. After investigating 29 cases of reported shingles following varicella vaccination, it was found that all 29 individuals experienced symptom improvement without any complications. Additionally, analysis of NHIS big data showed no significant differences in severity, including hospitalization duration after shingles occurrence, following vaccination. The KDCA explained, "The varicella vaccine is a live vaccine that uses weakened strains of bacteria or viruses. It is known that the symptoms of shingles after vaccination are generally milder than when shingles occur in individuals who have not been vaccinated against chickenpox." During the investigation, there had been one case of reported death suspected to be related to the varicella vaccine. However, the expert committee, including a blood cancer specialist, concluded that there is no causal relationship between the varicella vaccine and the reported death. Consequently, based on these results, the KECIP decided to continue using Sky Varicella Inj in national immunization. However, considering that the incidence of shingles after vaccination with Sky Varicella Inj is higher than with other vaccines, precautions will be advised for high-risk groups, such as prohibiting the administration of the vaccine to severe immune-compromised patients and pregnant women. The KDCA strongly advocated for vaccination, stating the significant preventive effect of the varicella vaccine, citing that the incidence of chickenpox among the unvaccinated group, based on those born in 2022, is nearly ten times higher than that of the vaccinated group. They also emphasized that Sky Varicella Inj’s preventative effect against smallpox is 78.9%, which is higher than that of other varicella vaccines. The KCDC said, "We urged the medical community to actively report cases of adverse events, such as shingles, after receiving the varicella vaccine." They added, "Enhanced surveillance of the safety of the varicella vaccine will be implemented, including conducting additional diagnostic tests when reporting adverse events." If any adverse reactions, such as high fever, rash, and shingles, occur after the vaccination in young children, report to the NIP internet website (https://nip.kdca.go.kr) or the monitoring system for vaccines (https://is.kdca.go.kr). For other inquiries, including the report process, contact the call center ☎1339 or the nearest public health center.
- Policy
- CPAC ‘Scemblix’s orphan drug designation is valid’
- by Lee, Hye-Kyung Jun 13, 2024 05:48am
- Pic of Scemblix The next-generation chronic myeloid leukemia drug ‘Scemblix (asciminib)’ is expected to be available for adult patients with chronic myeloid leukemia (CML) with the T315I mutation or Philadelphia chromosome-positive acute lymphocytic leukemia (Ph+ ALL) with the T315I mutation. According to the minutes of the Central Pharmaceutical Affairs Council that were disclosed by the Ministry of Food and Drug Safety on the 11th, the CPAC had discussed Scemblix’s orphan drug designation agenda at its last meeting. In Korea, Scemblix is currently only approved as a treatment for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase previously treated with two or more tyrosine kinase inhibitors (TKIs). Iclusig(ponatinib) is currently the only treatment option available for the "patients with T315I-positive CML," for which the CPAC has been discussing Scemblix’s orphan drug designation. Iclusig was designated as an orphan drug for “patients with T315I-positive CML” and “adult patients with chronic, accelerated, or acute phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphocytic leukemia (Ph+ ALL) that is resistant or intolerant to other tyrosine kinase inhibitors (TKIs). Regarding the designation decision, a CPAC member stated, "Scemblixworks in patients who are not sufficiently responding to treatment with other alternatives and in patients for whom alternative medicines are not available. Therefore, it is the only available alternative that offers improvement for difficult-to-treat patients.” According to data submitted by Novartis, Scemblix is a valid and viable alternative treatment option for CML patients with the T315I mutation, regardless of their Iclusig use. Also, the reported adverse events were manageable with dose adjustment, discontinuation, combination medications or supportive care, and a favorable safety profile compared to alternatives. The CPAC member said, "When considering the number of patients, prevalence, and safety and efficacy assessments, the results justify the drug’s orphan drug designation.” Another CPAC member said, “Given that the indication is limited to chronic myeloid leukemia and the submitted study is a Phase I study, its efficacy cannot be directly compared with Iclusig. However, in the submitted Phase I study, 38.5% of patients who have been previously treated with Iclusig achieved major molecular response (MMR). Given that Iclusig is the only treatment option for patients with T315I-mutant Ph+ CML, we believe that an orphan drug designation can provide patients and their physicians with more options.” Some noted that the definition of “significant” in the orphan drug designation criteria typically implies a statistically significant difference and that it would be unreasonable to conclude that a drug has significantly improved safety or efficacy based on the results of a Phase I trial. One member noted, "Given the limited number of CML patients with the T315I mutation, it will be some time before a direct comparison study is published.” However, the majority of committee members agreed that Scemblix is a viable treatment option for patients with leukemia that has become resistant to other therapies and that its orphan drug designation is valid.
- Company
- A growing trend of SC injections heats up competition
- by Son, Hyung-Min Jun 13, 2024 05:48am
- Pharmaceutical and biotech companies in Korea and worldwide focus on developing formulation modifications for anticancer agents. Following 'Tecentriq (atezolizumab)' SC (subcutaneous injection obtaining marketing authorization from the European Medicines Agency (EMA) in January, the R&D of 'Opdivo (nivolumab)' and 'Rybrevant (amivantamab)' is nearing the end. The industry attributes the recent booming development of SC formulations to their advantages over IV (intravenous) formulations, such as shortened administration time, improved convenience of administration, and reduced injection-related side-effects. According to the industry sources on June 11th, Bristol Myers Squibb (BMS)·ONO Pharmaceutical and Janssen disclosed the research outcomes of their SC formulations products, Opdivo and Rybrevant, respectively. Opdivo, an immunotherapy for cancerOpdivo, developed by BMS and ONO Pharmaceutical, is a PD-1-targeting immunotherapy for cancer. BMS conducted a clinical trial involving patients with renal cell carcinoma to change the Opdivo IV formulation to an SC formulation, and they obtained successful outcomes. The Phase 3 CheckMate-67T trial enrolled 495 patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior therapy. For safety profile, the percentage of patients with topical adverse reactions of all grades in the Opdivo SC group was 8.1%, and in the IV group, it was 2.0%. Among the patients who were anti-drug antibodies (ADA)-positive, 15.2% of the patients in the SC group experienced mild topical adverse reactions of Grade 1-2, which resolved without the need of treatment. SC formulation of Rybrevant, a targeted therapy for cancer, has also shown effects in a clinical trial. Rybrevant, developed by Janssen, is a treatment for patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. A recently disclosed Phase 3 PALOMA-3 study demonstrated the non-inferiority of SC formulation Leclaza plus Rybrevant therapy to IV formulation Leclaza plus Rybrevant therapy. At a median follow-up of 7 months, SC formulation of Leclaza plus Rybrevant therapy was non-inferior to IV formulation Leclaza plus Rybrevant therapy. Yuhan SC formulation of Leclaza plus Rybrevant therapy had an ORR of 30.1% compared to 32.5% in IV formulation Leclaza plus Rybrevant therapy, meeting the standard for non-inferiority. For injection-related reactions (IRR), SC formulation of Leclaza plus Rybrevant therapy showed 13% IRR, which was significantly lower than 66% in IV formulation Leclaza plus Rybrevant therapy. The analysis suggests that improving Rybrevant’s administration will lead to greater synergy when combined with Leclaza. One of the concerns about combining oral Leclaza with IV formulation Rybrevant is that it may be less convenient due to the increased number of hospital visits. Since oral formulations for targeted therapy for lung cancer, such as Tagrisso (osimertinib) and Giotrif (afatinib), have been approved, Rybrevenat’s injectable formulation poses a weakness. Therefore, whether SC formulation of Rybrevant would be commercialized is attracting attention. Latecomers have started developing SC formulations Latecomers to developing anticancer agents are working to change formulations to reduce the administration time. Roche has succeeded in developing SC formulation of Tecentriq, an immunotherapy for cancer, and MSD is conducting a phase 3 clinical trial of SC formulation of Keytruda. Alteogen, which has a SC formulation modification technology, plans to develop technology for ADC SC platform. Alteogen expects the SC formulation of ADC to reduce adverse reactions. The company aims to launch the SC formulation of ADC into the market by 2028. The Korean pharmaceutical biotech industry is working on developing potential SC formulations of anticancer candidates. GI Innovation is developing a SC formulation of GI-102, a candidate immunotherapy for cancer. According to GI Innovation, the SC formulation of GI-102 has a bioavailability (BA) of up to 60% compared to an IV formulation. A clinical trial for the SC formulation of GI-102 will be conducted by confirming an appropriate dose in patients with various solid cancers. Once a proper dose of the SC formulation of GI-102 is determined, GI Innovation plans to conduct a clinical trial for an incremental dose in patients with solid cancer who have failed systemic therapies. Additionally, several companies are working on a new formulation modification other than IV to SC. Daehwa Pharmaceutical is developing an oral paclitaxel formulation, Liporaxel Sol. In a phase 3 clinical trial conducted by Daehwa Pharmaceutical’s partnering company in China, Haihe Biopharma, the efficacy and safety of Liporaxel have been confirmed to be non-inferior to paclitaxel injection.
- Policy
- 9th meeting held for external reference pricing reevals
- by Lee, Tak-Sun Jun 13, 2024 05:48am
- The government and the pharmaceutical industry held the 9th meeting on external reference pricing reevaluations but reportedly decided to continue discussions. Initially, the 9th meeting was supposed to be the last in the opinion-gathering process, but further meetings were deemed inevitable. According to industry sources, the government and the pharmaceutical industry held the 9th round of talks on the external reference pricing reevaluations at the Kukje Electronic Center in Seocho-gu on the 12th. This is the 9th round of talks since it began in November last year. As the government’s proposal for the method of comparison came out at the 8th meeting, the 9th meeting was expected to be the time to refine the final draft based on industry opinions. The industry also needed time to review the proposal, which was why the 9th meeting was pushed back to June instead of May after the 8th was held at the end of April. At the 9th meeting, the pharmaceutical industry made various demands. Although there was disagreement on the government’s method of comparing the A8 average price, which excludes the highest and lowest prices, the method is expected to be maintained as is. However, the parties reached a consensus that further discussion is needed on which drugs should be excluded from revaluations, the method of searching for foreign drug prices, and on whether to put a lower limit on the rate of drug price cuts. The 10th meeting is expected to be held after July to discuss the specifics. An industry official who attended the meeting said, "The industry made a lot of suggestions and decided to continue on the discussions. However, there seems to be no room for change in the comparison method proposed by the government."
- Company
- ‘Verify safety when using botulinum toxin for hair loss'
- by Nho, Byung Chul Jun 12, 2024 05:45am
- Dr. Jae-Hong Kim, Director of Planning and Policy at the Association of Korean Dermatologists (Chief Director, Yonsei Joeun Dermatology Clinic Gwangmyeong Branch)The market for hair loss treatment is growing day by day as hair loss, once considered a typical condition of middle-aged men, has become a general condition across all genders and ages. In particular, the market is being segmented across a wide age range and various lifestyles, and new treatments that complement the limitations of existing treatments are being actively developed. Dr. Jae-Hong Kim, Director of Planning and Policy at the Association of Korean Dermatologists, said, "Androgenetic alopecia (AGA), the most common type of hair loss, is generally treated with oral medications, but if the patient has inadequate drug response, the treatment’s effect decreases after a certain period of time. In recent years, procedures with different mechanisms of action, such as botulinum toxin, have emerged as a new alternative to treat hair loss." Botulinum toxin is a neurotoxin that inhibits the release of acetylcholine, a neurotransmitter that prevents muscles from contracting. It causes a temporary relaxation and shrinkage response in the muscle and is commonly used to treat wrinkles such as crow's feet and frown lines or to shrink overdeveloped muscles such as trapezius and calves. Kin explained, "When injected into the dermis, botulinum toxin has been shown to reduce the activity of TGF-ß1, which is responsible for hair loss. It is known to improve hair loss by increasing blood circulation by relaxing of the muscles around the scalp when injected intramuscularly." Research and publications on the effectiveness of botulinum toxin in treating hair loss are actively being conducted and published in the field. "There was a case of a man in his 30s and 40s who had advanced hair loss with thinning hair in the crown area along with scalp heat. He did not see any significant effect from oral medications, but experienced symptom improvement after receiving botulinum toxin injections in the balding areas.” However, as hair loss can have a significant impact on a patient's social and interpersonal life, it is important to carefully check the safety of the administered products. The safety and product history can be checked through the product’s FDA approval status and proven titer in the global market. In Korea’s botulinum toxin market, products such as Botulax have been approved by the FDA and have entered big markets such as Europe and China, and have been recognized for both its efficacy and stability. Accurate diagnosis and proper treatment by a medical professional are also important to achieve the best results. He added, "Patients tend to rely on arbitrary treatments or folk remedies, fearing side effects of oral medications or painful injections, which can cause them to miss the right timing to receive treatment. As various treatment methods are now available, patients should consult with a medical team to develop a treatment plan that takes into account each patient’s individual characteristics and the mechanism of action of the drug."
- Company
- Autotelic Bio signs licensing agreement with Chinoin
- by Nho, Byung Chul Jun 12, 2024 05:45am
- (From the left) Fernando Torres Navarrete, BD Director at Chinoin Productos Farmaceuticos in Mexico , Tae-Hun Kim, CEO of Autotelic Bio Autotelic Bio announced on the 7th that it has signed an exclusive license and supply agreement with Chinoin Productos Farmaceuticos in Mexico to distribute ATB-101, a novel combination drug for the treatment of hypertension and diabetes. ATB-101 is a fixed-dose combination product comprising of the hypertension drug ‘olmesartan’ and the oral diabetes drug ‘dapagliflozin.’ It is the world's first combination drug that treats both hypertension and Type 2 diabetes, making it easier for patients with both chronic diseases to take their medication. The company has received Phase III IND approval from the Ministry of Food and Drug Safety for ATB-101 and is currently conducting Phase III clinical trials in patients with essential hypertension and type 2 diabetes at more than 35 major hospitals in Korea, including Seoul National University Bundang Hospital. Autotelic Bio is planning to launch the product globally after proving safety and efficacy through the ongoing Phase 3 clinical trial. For this, the company has registered composition patents in the U.S., Japan, Russia, Mexico, and Brazil, in addition to Korea, and is expanding its patent to other countries such as China. The exclusive license and supply agreement it signed in Mexico is to supply more than 30 million ATB-101 tablets over 5 years. The agreement demonstrates the company's potential to expand into neighboring Latin American countries through Chinosa and is expected to serve as a bridgehead for future global expansion. In addition to the upfront payment, Autotelic Bio will receive additional payments based on development, licensing, and commercialization milestones. Mexico's hypertension and diabetes market is the second largest in Latin America after Brazil and has significant potential. Autotelic Bio plans to grow sales in the Mexican market and reinvest the proceeds in the continued development of innovative new medicines. Chinoin Productos Farmaceuticos is a Mexican pharmaceutical company founded in 1924. It owns a pharmaceutical R&D, manufacturing, licensing, sales, and marketing division, and is regarded to have excellent sales and marketing capabilities, ranking among the top 10 pharmaceutical sellers in Mexico. Autotelic Bio recently completed a pre-IND meeting with the U.S. Food and Drug Administration (FDA) to advance ATB-101 into the United States. During the meeting, the company received a positive response from the FDA regarding the ongoing Phase III clinical trial, and that an additional local Phase I clinical trial will be sufficient for approval in the U.S. based on the results of the domestic Phase III trial. Based on the results of the pre-IND meeting, the company will be meeting with more than 10 pharmaceutical companies at Bio USA to discuss global rights agreements for ATB-101, including in the US. This year, Autotelic Bio has joined the Boston C&D Incubation Office, a blockbuster global expansion program organized by the Korea Health Industry Development Institute (KHIDI), to strengthen its network for ATB-101’s clinical development and licensing-out activities and create results in the U.S. market. In addition to the incrementally modified drug, Autotelic Bio is developing two other RNA-based anti-cancer drugs, ATB-320 (a dual-mechanism of action anti-cancer RNA drug that works on the TME and inhibits angiogenesis) and ATB-350 (a next-generation KRAS mutation-targeting anti-cancer RNA drug that targets specific tissue). Also, its ATB-610 (ALK5 inhibitor), an inhaler in the company’s anti-fibrosis drug pipeline, has been selected as a project of the National New Drug Development Project in Korea, adding momentum to the company’s development of new drugs.
