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- 2025-12-20 23:10:39
- Company
- Rinvoq joins the competition in the alopecia areata trt. mkt
- by Whang, byung-woo Aug 04, 2025 05:53am
- AbbVie's JAK inhibitor Rinvoq (upadacitinib) is expected to enter the market competition following successful clinical trials for alopecia areata. Product photo of RinvoqAbbVie recently announced positive topline results from the No.2 study of the Phase 3 clinical program (UP-AA program) for Rinvoq in adult and adolescent patients with severe alopecia areata. In this trial, the primary endpoint has been met, with a significant increase in the proportion of patients achieving 80% or more scalp hair regrowth (the primary endpoint) at Week 24 compared to the placebo group. Based on these results, Rinvoq emerged as a strong candidate to join the alopecia areata treatment market. Specifically, 44.6% of patients in the Rinvoq 15mg arm and 54.3% in the Rinvoq 30mg group achieved 80% or more scalp hair regrowth (SALT score ≤20) at Week 24, compared to only 3.4% in the placebo group. Key secondary endpoints, including improved eyebrow and eyelash hair growth, achieving ≥90% scalp hair regrowth (SALT ≤10), and attaining complete scalp hair regrowth (SALT=0), were also met in both Rinvoq dose groups. The safety profile was largely consistent with what has been observed in existing Rinvoq indications, with no new safety signals identified. Arash Mostaghimi, Professor of Dermatology at Harvard Medical School and Brigham and Women's Hospital, said, "The sudden and often unpredictable hair loss experienced by patients with alopecia areata severely impacts their self-esteem and mental health," and added, "There is a desperate need for more therapies that help hair regrowth on the scalp and other areas. These results, showing the potential for upadacitinib to be an important new treatment option, are very favorable." Kori Wallace, the Vice President and Global Head of Immunology Clinical Development at AbbVie, stated, "UP-AA is the first pivotal clinical study to establish and achieve high goals such as SALT=0. These study results demonstrate AbbVie's commitment to advancing new therapies with the potential to improve the lives of patients with immune-mediated diseases." AbbVie plans to initiate global regulatory procedures based on these results. The clinical trial results announced included patients from Korea, suggesting that a swift approval process is anticipated. Third alopecia areata treatment is expected to emerge, and competition is anticipated If Rinvoq receives marketing authorization, it will become the third JAK inhibitor available in the domestic alopecia areata treatment market. Currently, two oral JAK inhibitors, Eli Lilly Korea's Olumiant (baricitinib) and Pfizer Korea's 'Litfulo (ritlecitinib),' can be used for the treatment of severe alopecia areata in Korea. Olumiant, approved by the Ministry of Food and Drug Safety (MFDS) in March 2023, became the first treatment for severe alopecia areata in adults in Korea. This drug was approved based on the results of the BRAVE-AA clinical trial, which showed that at 36 weeks, approximately 38.8% of patients receiving the 4 mg dose achieved 80% or more scalp hair regrowth, demonstrating superior efficacy compared to the placebo group (6.2%). Litfulo, the first alopecia areata treatment to gain an indication for adolescents aged 12 and older, received MFDS approval in September 2024 and was launched in Korea in March this year. In terms of mechanism of action, Olumiant simultaneously inhibits JAK1 and JAK2, while Litfulo selectively acts on JAK3 and TEC family kinases. The prevailing view in clinical settings is that sufficient data on treatment outcomes is needed for these two therapies, as a direct comparison is currently challenging. However, for adult patients, Olumiant could be considered for faster hair regrowth, while Litfulo might be preferred if safety concerns, such as the risk of infection, are prioritized. Compared to Olumiant, Litfulo is in the stage of accumulating prescription experience since its domestic launch, and its efficacy and safety profile in real-world patient populations will need further observation. (from left) Litfulo and Olumiant The late entrant Rinvoq is expected to join the market competition, backed by strong Phase 3 data. Rinvoq, as a selective inhibitor of JAK1, has a distinct target profile from existing drugs and is expected to appeal based on its proven efficacy and accumulated safety data from previous immune disease indications, such as atopic dermatitis. Notably, the high response rate of approximately half of the patients at week 24, confirmed in this trial, is expected to be a distinct strength in terms of short-term efficacy compared to competing drugs. Furthermore, adolescent patients were included in Rinvoq's global clinical trials, suggesting a high probability of securing an indication for ages 12 and older, similar to Litfulo, if approved in the future. This indicates that, in competition with Olumiant, which is limited to adult patients, Rinvoq will have a broader patient population. In competition with Litfulo, the experience accumulated in various indications, such as atopic dermatitis, will be a differentiating point. AbbVie has already successfully established Rinvoq as a treatment for atopic dermatitis in the dermatology field, leading to observations that it will effectively expand the alopecia areata indication to dermatology specialists, who are in the same prescribing group. In terms of treatment accessibility, the successive emergence of Olumiant and Litfulo in the field of alopecia areata, which previously had no approved treatments, marked a turning point in the treatment paradigm. With Rinvoq being introduced, the range of treatment options is expected to broaden further. However, the fact that alopecia areata cannot be reimbursed with the National Health Insurance and remains as the non-reimbursed drug is expected to be a barrier to market expansion.
- Company
- Janssen, Pharma distribution industry agree on margin adj
- by Son, Hyung Min Aug 01, 2025 06:18am
- The conflict between Janssen Korea and the pharmaceutical distribution industry over distribution margin reductions has been resolved with a negotiated settlement. The distribution industry achieved an outcome that maintains existing trade relationships, including with small and medium-sized distributors, while also improving the proposed margin reduction terms. Janssen Korea, in turn, reconfirmed its commitment to cooperation with the distribution industry, setting a precedent for mutual growth. According to industry sources, on August 1, the Korea Pharmaceutical Distribution Association recently announced that it has reached a final agreement with Janssen Korea regarding the reduction in distribution margin, following numerous negotiations. Notably, trade was maintained even for small and medium-sized distributors whose contracts were nearing expiration, and the entire distribution industry is deemed to have secured fair trade conditions without the involvement of the Fair Trade Commission. Previously, Janssen Korea had notified its distribution partners of a plan to pursue a two percentage point reduction from existing margins. While there were variations depending on individual contract terms, for example, a distributor with an existing 8% margin would see it adjusted to 6%. The distribution industry's position was that while some pharmaceutical companies had attempted margin adjustments of around one percentage point, a two percentage point adjustment was unprecedented. In response to this measure, member companies in Korea protested, standing firm and expressing their intent to refuse the distribution of Janssen products, stating that "they cannot handle products at a loss if margin cuts are enforced." In response, the Association immediately formed an emergency response committee and held several rounds of negotiations with Janssen Korea. Both sides narrowed their differences and finally formulated a negotiation proposal. While the specific details remain confidential, according to the Distribution Association, the distribution margins have been adjusted to an acceptable level, and trade terms that had burdened the distribution industry have been improved. The fact that small and medium-sized distributors whose contracts were expiring were not marginalized and could continue their business is considered a significant achievement. The pharmaceutical distribution industry and Janssen Korea officially convened a meeting to discuss distribution margin reductions. The Korea Pharmaceutical Distribution Association feels that this margin reduction conflict with Janssen Korea has strengthened its internal cohesion and external negotiation power. An official from the Distribution Association said, "Throughout numerous meetings, we conducted negotiations, conveying the strong voices of our member companies and the demand for mutual growth with the distribution industry. As negotiations continued, Janssen Korea, which had initially been unyielding, came to a consensus with the association and the distribution industry regarding the margin reduction, thus concluding the negotiations." Janssen Korea also issued a positive statement. The company said, "Through this negotiation, we were able to derive positive alternatives related to margin rates with our distribution companies," and added, "We thank the pharmaceutical distribution industry for their cooperation and are pleased to be able to continue a patient-centered collaborative relationship in the future." Park Ho-young, Chairman of the Korea Pharmaceutical Distribution Association, said, "This is the result of conveying the opinions of our member companies directly and not giving up until the end." He added, "While the outcome may not be entirely satisfactory for some member companies, the fact that we created an opportunity for mutual growth through the united strength of the distribution industry is positive." Park stated, "With margin reductions recurring over a long period, the distribution industry has already reached its acceptance limit," and added, "Pharmaceutical companies should refrain from easily resolving their management difficulties through margin adjustments."
- Policy
- ENT and pediatric departments prescribe the most drugs
- by Lee, Hye-Kyung Aug 01, 2025 06:16am
- Last year, medical institutions prescribed an average of 3.85 drugs per prescription. Outpatient clinics prescribed the most at 3.94, followed by hospitals at 3.88, general hospitals at 3.48, and tertiary hospitals at 3.10. The percentage of medical institutions prescribing 6 or more drugs increased by 0.79% from 18.34% in the previous year to 19.13%. These figures were released on the 31st by the Health Insurance Review and Assessment Service in its “2024 Drug Reimbursement Adequacy Assessment Results.” In the case of tertiary hospitals, the standard deviation in the number of drugs per prescription between institutions ranged from 2.60 at the lowest to 3.98 at the highest, indicating no significant difference. In contrast, clinics showed a range of 1.00 at the lowest to 8.89 at the highest, revealing a substantial difference. By age group, the number of drugs per prescription was highest for infants at 4.65, followed by children and adolescents at 4.25, adults at 3.75, and the elderly at 3.62. Among tertiary hospitals, the number of drugs prescribed for the elderly was the highest at 3.34, while general hospitals, hospitals, and clinics had higher rates for infants at 4.39, 4.90, and 4.62, respectively. The most common condition for medication prescriptions was acute lower respiratory tract infection, with 5.12 drugs prescribed per prescription. This was followed by acute upper respiratory tract infection at 4.77 and other upper respiratory tract disorders at 4.66. The number of drug items per prescription at clinics was 3.94, an increase of 0.03 from 3.91 in the previous year. By subject, the highest numbers were in otolaryngology (4.80), pediatrics (4.62), and general medicine/family medicine (3.97). By region, the ratio of the number of drug items per prescription was highest in Sejong (4.14%), then Incheon (4.04%), then Jeonbuk (4.03%), and lowest in Daegu (3.82%), then Seoul and Daejeon (3.85%). The prescription rate for 6 or more items was 18.143%, with tertiary general hospitals at 13.08%, general hospitals at 15.25%, hospitals at 19.02%, and clinics at 19.19%. Among clinics, 18,317 institutions (54.53%) had a prescription rate of 10% or less for six or more items, which was the highest number, and the ratio decreased by 0.99% compared to the previous year. Institutions with a rate of 40% or higher for prescribing six or more items accounted for 2,063 institutions (6.14%), with the highest rates observed in otolaryngology (29.22%) and pediatrics (20.76%) departments. The antibiotic prescription rate for acute upper respiratory tract infections was 45.20%, with tertiary general hospitals at 7.15%, general hospitals at 34.67%, hospitals at 53.60%, and clinics at 44.87%. Compared to the previous year, the rate increased the most in clinics (increased 3.97 percentage points). The number of institutions with an antibiotic prescription rate for acute upper respiratory tract infections below 10% was the highest at 3,320 (22.26%), a decrease of 3.23 percentage points compared to the previous year. The number of institutions with an antibiotic prescription rate for acute upper respiratory tract infections of 70% or higher was 2,338 (15.67%). The antibiotic prescription rate for acute upper respiratory infections at clinics was 44.87%, with the highest rates in otolaryngology (51.76%), pediatrics (46.07%), and general medicine (42.72%). By region, the rates were highest in Gwangju (50.23%), Chungnam (49.05%), and Chungbuk (47.97%), and lowest in Ulsan (42.06%), Daejeon (42.20%), and Seoul (42.50%). The antibiotic prescription rate for acute lower respiratory tract infections was 61.86%, with 21.73% at advanced general hospitals, 48.84% at general hospitals, 59.55% at hospitals, and 62.29% at clinics. The antibiotic usage per patient was 1,837.9 DDD for acute upper respiratory tract infections, 2,672.5 DDD for acute lower respiratory tract infections, and 2,463.0 DDD for respiratory diseases.
- Policy
- PPP also proposes free HPV vaccination for ppl under 26
- by Lee, Jeong-Hwan Aug 01, 2025 06:16am
- Following the ruling party, the main opposition party, the People Power Party, also submitted a bill to the National Assembly to provide free HPV vaccines to all citizens aged 26 and under, regardless of gender. The People Power Party’s bill also included provisions to expand the scope of free influenza vaccinations beyond the current coverage. This would involve increasing the age eligibility for influenza vaccines under the National Immunization Program (NIP), which was previously only applied to children, adolescents, and the elderly. Currently, three types of HPV vaccines are approved in South Korea: Cervarix (bivalent), Gardasil (Quadrivalent), and Gardasil 9 (9-valent). If the legislation is passed, the expansion of the scope of NIP is expected to bring positive outcomes. Currently, only Cervarix and quadrivalent Gardasil are included in the NIP, but the demand for Gardasil 9’s inclusion in the NIP will likely grow if the legislation is enacted. On the 31st, People Power Party member Mi-ae Kim introduced a bill to amend the Infectious Disease Control and Prevention Act to include these provisions. Expanding eligibility for free HPV vaccinations to both men and women was a common campaign promise of both the ruling and opposition parties in the last presidential election. Until now, only the ruling party had submitted related bills to the National Assembly (by Reps. Hee-seung Park and Sujin Lee), but with Rep. Mi-ae Kim introducing a bill with the same intent, the legislation is gaining momentum. Rep. Kim pointed out that HPV is a virus that can cause various diseases, including cervical cancer, anal cancer, and oral cancer, and can affect both men and women. However, she said that the issue is that the current NIP is limited to “women aged 12 to 26.”. To address this, Rep. Kim introduced a bill to include anyone under the age of 26, regardless of gender, in the free HPV vaccination program. In addition, Rep. Kim’s bill includes a provision to expand the scope of free influenza virus vaccinations. Currently, the NIP (free vaccination) for influenza vaccines is limited to “pregnant women, children aged 13 and under, and seniors aged 65 and over.” In the bill, Representative Kim expanded the scope of free influenza vaccinations to “those aged 18 and under and those aged 62 and over.” Rep. Kim explained, “Considering that most children engage in group activities at school until around the age of 18, it is necessary to extend the age range for vaccination to 18 to more thoroughly prevent the spread of the influenza virus. In addition, vaccination support for the elderly, who are vulnerable to influenza, must be strengthened further.” Meanwhile, the Democratic Party of Korea has proposed swift passage of bills related to the common campaign pledges of both parties during the presidential election to PPP and other opposition parties, which include free HPV vaccinations for both men and women.
- Company
- NMOSD drug Enspryng’s reimbursement expanded in KOR
- by Whang, byung-woo Aug 01, 2025 06:16am
- Pic of Enspryng Roche Korea announced on the 31st that the reimbursement criteria for Enspryng (satralizumab), a treatment for neuromyelitis optica spectrum disorder (NMOSD), will be expanded from August 1st per a notification from the Ministry of Health and Welfare. Enspryng is indicated for the treatment of adult patients with anti-aquaporin(AQP4) antibody-positive NMOSD. It selectively targets the interleukin-6 (IL-6) receptor, a key pathogenic factor in the disease, to inhibit IL-6 signaling. As the only subcutaneous injection formulation approved for NMOSD, it allows for maintenance therapy with a single subcutaneous injection every four weeks. This revision of the reimbursement criteria comes about a year and a half after Enspryng was first listed for reimbursement in December 2023. Under the revised notification, the criteria for Enspryng’s reimbursement, which previously required at least two symptom relapses within the last two years, have been relaxed to allow reimbursement only after at least one symptom relapse within the past year. Under the previous reimbursement criteria, patients had to wait for their second relapse of symptoms, even if they experienced their first relapse during initial treatment, before they could be prescribed Enspryng. However, with the revision, the treatment environment has been improved so that patients can quickly receive reimbursement for Enspryng even if they experience only one relapse during existing treatment. The expansion is expected to allow more patients with relapsing NMOSD to enjoy Enspryng’s treatment benefits. NMOSD is an inflammatory autoimmune disorder of the central nervous system that can cause lifelong physical weakness. Eight to nine out of ten patients experience recurrent relapses, and as even a single relapse can cause severe neurological deficits, early and aggressive relapse prevention treatment is crucial. Enspryng’s safety and efficacy in reducing the risk of relapse were demonstrated through two global Phase III trials - SAkuraStar and SAkuraSky - that were conducted on adult NMOSD patients. Study results showed that in anti-aquaporin-4 antibody-positive patients, approximately 9 out of 10 patients receiving combination therapy with immunosuppressants and approximately 7 out of 10 patients receiving monotherapy with Enspryng remained relapse-free at approximately 2 years (96 weeks). No cases of death or anaphylaxis (hypersensitivity reactions) were reported following Enspryng administration in either clinical study, and most adverse reactions were mild to moderate in severity. In particular, recently published real-world data from Japan showed that 96.6% of patients treated with Enspryng did not experience recurrence at 6 months (26 weeks). "Enspryng is an innovative treatment that has demonstrated its effect in reducing the risk of recurrence in patients with NMOSD in multiple clinical studies,” said Ezat Azem, General Manager of Roche Korea. “With the reimbursement expansion, patients who experience relapse with existing treatments will be able to use Enspryng more quickly without unnecessary delays, which will contribute to improving treatment outcomes and quality of life for patients.”
- Opinion
- [Reporter's View] KRPIA opts for 'maintain' over 'change'
- by Eo, Yun-Ho Aug 01, 2025 06:15am
- The Korea Research-based Pharma Industry Association (KRPIA) has chosen continuity over change. The KRPIA recently confirmed the appointment of Vice Chairman Lee Young-shin (68) to the position of Executive Vice Chairman, who is currently leading the association. This decision was made after amending the articles of incorporation to address the appointment of the Executive Vice Chair. Initially, the articles of association permitted only one re-appointment to the Vice Chair. Vice Chair Youngshin Lee had already been re-appointed once since his initial appointment in 2019. Therefore, a change in Vice Chair was highly probable upon the expiration of his term, but the association decided to amend its articles of incorporation and maintain the existing system. Historically, KRPIA has favored former government officials for the position of Executive Vice Chair. Given the nature of multinational pharmaceutical companies, whose core business is the supply of new drugs, communication with ministries related to the drug pricing system is crucial, and government connections are indeed crucial. Due to various reasons, the association has not appointed any former government officials since the resignation of former Vice Chair Lee Sang-seok, and Vice Chair Youngshin Lee 's second re-appointment has been confirmed. There must be a reason for this unusual decision. KRPIA has seen significant changes in its personnel composition over the past few years. While the reduction in the number of board members is an unavoidable consequence of the reassignments inherent in multinational company CEO positions, the frequent departures of government relations personnel, including former Policy Director Min-Young Kim, have led to substantial personnel gaps. Additionally, since February of last year, In-hwa Choi, the current Executive Director of Policy and External Affairs, has been appointed, and other vacant positions have been filled, resulting in the current state. New drugs and drug pricing are currently at a more critical juncture than ever before. Amid concerns about 'Korea Passing' due to the Trump administration's pressure on South Korea's drug pricing policy and a flood of high-priced drugs, the future policy direction could significantly impact public health in Korea. South Korea's drug pricing system, including that of generics, could face significant challenges. Moreover, a new government has just taken office. KRPIA's role will undoubtedly be paramount. The decision has been made, and now it's time to move forward. Beyond merely defending drug prices, we look forward to the association operating with rational and sharp judgment to find common ground with health authorities and lead to agreement on the overarching premise of 'improving patient accessibility.' This, along with a re-evaluation of the priorities for past government activities and policy proposals.
- Company
- Roche's HR+ breast cancer drug 'Itovebi' wins nod in Korea
- by Whang, byung-woo Aug 01, 2025 06:15am
- Product photo of ItovebiRoche Korea announced on July 30 that it has received approval of the breast cancer treatment Itovebi (inavolisib) from the Ministry of Food and Drug Safety. Itovebi, recently approved, can be used for the treatment of PIK3CA mutation-positive, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer patients. Itovebi is indicated to be used in combination with palbociclib and fulvestrant therapy in adult patients with locally advanced or metastatic HR+, HER2-, and PIK3CA gene mutation-positive breast cancer that has recurred within 12 months during or after adjuvant endocrine therapy. For patients with a history of CDK4/6 inhibitor treatment as adjuvant therapy, it must be more than 12 months since the end of the CDK4/6 inhibitor treatment. For premenopausal and male patients, LHRH agonists are co-administered. Hormone receptor-positive breast cancer is the most common type, accounting for approximately 60% of all breast cancers, and about 40% of these are estimated to have a PIK3CA gene mutation. Activation of the PIK3CA mutation results in the dysregulation of the PI3K signaling pathway. Thus, existing treatments alone are often insufficient, resulting in a poor prognosis. The current approval is based on the Phase 3 INAVO120 study, which confirmed the clinical utility and safety of Itovebi. In 161 patients with locally advanced or metastatic HR+, HER2-, and PIK3CA mutation-positive breast cancer whose disease progressed within 12 months during or after adjuvant endocrine therapy, and who had no prior systemic treatment, Itovebi in combination with palbociclib and fulvestrant therapy showed a significant overall survival (OS) benefit compared to the control group (n=164) receiving placebo in combination with palbociclib and fulvestrant. Additionally, a median follow-up of 34.2 months, the median overall survival (OS) for the Itovebi treatment group was 34 months (95% CI, 28.4-44.8), and the risk of patient death was reduced by 33%. In contrast, the median overall survival for the control group (at a median follow-up of 32.3 months) was 27 months. Professor Seock-ah Im of Seoul National University Hospital's Department of Hemato Oncology, who led the INAVO120 study, explained, "The PIK3CA mutation promotes tumor growth and rapidly progresses the disease, which can lead to a poor prognosis, thus creating a significant unmet need for new treatments in this area." She added, "Itovebi has not only confirmed more than double the extension of progression-free survival (PFS) compared to existing standard therapies in patients with PIK3CA mutations, but it is also the only PI3K inhibitor to confirm overall survival extension." Ezat Azem, CEO of Roche Korea, said, "We are pleased to provide a new first-line treatment option for domestic PIK3CA gene mutation breast cancer patients, for whom treatment options have been limited," and added, "As a leader in breast cancer treatment, we will continue to contribute to the advancement of the breast cancer treatment environment in Korea." Meanwhile, Itovebi is Roche's first targeted therapy in the hormone receptor-positive field, following its leading position in HER2+ breast cancer treatment with Herceptin, Kadcyla, Perjeta, and Phesgo. Itovebi received Breakthrough Therapy designation from the U.S. FDA in May 2024 and FDA approval in October of the same year.
- Company
- Beyfortus likely to face restrictions on public advertising
- by Whang, byung-woo Jul 31, 2025 06:15am
- Sanofi is now compelled to revise its strategy as public advertising of Beyfortus (nirsevimab), an RSV preventive antibody injection, faces regulatory obstacles in Korea. Pic of Beyfortus According to Dailypharm’s coverage, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) Drug Advertising Review Committee ruled that Beyfortus is “not subject to advertising review.” In South Korea, vaccines for the prevention of infectious diseases are classified as prescription drugs or over-the-counter drugs, and are allowed some advertising to the general public. However, under the Regulations on Prior Review of Pharmaceutical Advertisements, vaccine advertisements must undergo prior review by the KPBMA’s Advertising Review Committee. In effect, the KPBMA’s decision has made it difficult for Beyfortus to be advertised on TV or online to general consumers. Beyfortus is an antibody injection that is administered once to all newborns and infants under 12 months of age to prevent RSV infection for at least 5 months, and it was approved by the Ministry of Food and Drug Safety in April last year. Inoculation with Beyfortus began in domestic hospitals and clinics starting in early February and has been administered to infants and young children, and is now being approved by drug committees in general hospitals as well. Sanofi has been working to raise awareness of RSV disease with the launch of its product. A representative example is the “RSV Story Contest,” which aims to collect and share experiences about the disease. However, in the case of Beyfortus, the company will face limitations in building brand awareness and expanding market reach through public advertising, which is the most straightforward way to promote the product. With the approval of Beyfortus, Sanofi has taken steps to raise awareness of the disease. The current Pharmaceutical Affairs Act imposes strict regulations on advertising for prescription drugs. According to Article 68, Paragraph 6 of the Pharmaceutical Affairs Act, prescription drugs, except for vaccines, may only be advertised in specialized media or academic journals targeting medical and pharmaceutical professionals. Public media advertising is exceptionally permitted for vaccines used for preventive vaccination, but public advertising for other prescription drugs is prohibited. Beyfortus is approved for preventive purposes, but as it was approved as an antibody drug, not a vaccine, it is not covered by this exception. The advertising ban has caused quite a stir. First, the company now has an urgent need to raise awareness of the product through other means. Normally, when a new vaccine is released, a large-scale vaccination campaign is launched through TV commercials and online promotions, but this is rendered difficult for Beyfortus. In addition, existing premium vaccines have employed strategies such as using celebrities as models to naturally promote specific vaccines as “OOO vaccines,” but this has also become difficult. In other words, Sanofi, which wanted to promote Beyfortus in the domestic market through advertisements, will inevitably face restrictions on its future marketing strategies. As a solution, Sanofi is expected to shift its sales and marketing focus to medical professionals, akin to the prescription drug market. With general consumer advertising blocked, Sanofi is likely to prioritize product promotion through medical professional channels such as academic conferences and symposia. This is an indirect marketing approach that aims to increase consumer awareness through indirect promotional activities centered on departments such as pediatrics, obstetrics and gynecology, and infectious diseases. In fact, it is rumored that several obstetrics and gynecology hospitals have already begun recommending Beyfortus vaccinations to parents of newborns. In this regard, Sanofi is still awaiting the results of KPBMA’s preliminary review. A Sanofi official stated, “The possibility of advertising Beyfortus to the general public is currently under review by the KPBMA, and we are awaiting the results of the review.”
- Policy
- MOHW seeks measures to attract domestic investment
- by Lee, Jeong-Hwan Jul 31, 2025 06:15am
- The government is seeking ways to encourage multinational pharmaceutical companies to strengthen domestic investment, including the establishment of new pharmaceutical production plants in Korea. However, international trade issues and other obstacles remain to be overcome to attract domestic investment from multinational pharmaceutical companies, and it remains uncertain whether practical measures can be established. On the 30th, the Ministry of Health and Welfare announced this plan in response to the National Assembly Health and Welfare Committee's inquiry regarding the current status of domestic investment by global pharmaceutical companies and incentives. The MOHW agreed with the committee in that in order for South Korea to become a pharmaceutical and bio powerhouse, it is essential to not only expand investment by domestic pharmaceutical companies but also attract investment from global pharmaceutical companies. As an example of a global pharmaceutical company establishing a factory or production base in South Korea, the MOHW cited Janssen Vaccines, which operates a biopharmaceutical manufacturing plant in Songdo, Incheon. Another example is Otsuka Pharmaceutical Korea, which operates a factory in Hwaseong, Gyeonggi Province, capable of synthesizing active pharmaceutical ingredients and producing finished pharmaceutical products. The MOHW announced that it will investigate whether multinational pharmaceutical companies are willing to invest in Korea, what their difficulties are, and what incentives would be effective in attracting investment. To this end, the MOHW is expected to meet with the Korean Research-based Pharmaceutical Industry Association (KRPIA) to discuss the multinational pharmaceutical companies’ interest in domestic investment. The MOHW stated, “Domestic investment by global pharmaceutical companies has many positive effects in terms of securing infrastructure and creating jobs,” adding, “We will work with relevant associations to identify the investment intentions and difficulties of global pharmaceutical companies in Korea and come up with measures to attract investment.”
- Company
- MSD Korea begins Januvia drug price difference compensation
- by Son, Hyung Min Jul 31, 2025 06:14am
- Product photo of Januvia products There are changes regarding the Januvia drug price difference compensation issue, which had been stalled for nearly two years. MSD Korea has officially informed the distribution industry that it will begin accepting applications for Januvia compensation starting next month, August 1. However, this compensation is limited to the quantity sold before the transfer of marketing rights to Chong Kun Dang, and whether compensation on sales will be made still requires discussion. According to industry sources on the 31st, MSD Korea sent an official letter to the Korea Pharmaceutical Distributors Association on the 29th, stating that it will begin accepting applications for compensation due to the Januvia drug price reduction starting August 1st. This compensation will apply only to the quantity directly sold by MSD Korea before July 15, 2023, the date when Chong Kun Dang acquired exclusive domestic marketing rights for Januvia. Until now, the disagreement between MSD Korea and Chong Kun Dang regarding Januvia drug price difference compensation had not narrowed, leading to ongoing confusion in the distribution industry and local pharmacies. However, with MSD Korea announcing the compensation procedure for the drug price reduction, it is expected that discussions on compensation will begin. An MSD Korea official said, "We believe a significant portion of the inventory still exists with pharmaceutical distributors and healthcare institutions." They added, "We will proceed with compensation through prompt and accurate procedures to minimize damage." They further added, "We have continuously put efforts into responding responsibly regarding compensation for the price difference due to the Januvia drug price reduction," and explained, "We plan to begin accepting compensation applications starting August 1st and officially proceed with the procedures." However, the party responsible for compensation for sales made after July 15, 2023, the date of the marketing rights transfer, has not yet been determined. The drug prices for the Januvia family products, including Januvia, Janumet, and Janumet XR, were sequentially reduced between September and October 2023 due to patent expirations. MSD Korea stressed its position that it has no responsibility for compensation for the period after September 2023, the time of the Januvia drug price reduction, as Chong Kun Dang took over exclusive sales and revenue rights for Januvia following the marketing rights transfer agreement. Januvia is a DPP-4 inhibitor, containing sitagliptin, used to treat diabetes and is developed by MSD. Following Januvia's launch, MSD and Chong Kun Dang have been jointly promoting these products since 2016. However, in 2023, MSD Korea reorganized its chronic disease business unit to focus on its oncology and vaccine businesses, transferring the rights for the Januvia Family to Chong Kun Dang. Chong Kun Dang has been exclusively handling the domestic sales of Januvia as of July 15, 2023. MSD Korea's position is that since the marketing and revenue rights were already transferred at that time, they bear no responsibility for compensation related to the drug price reduction after September 2023, when the price cut occurred. MSD Korea said, "We transferred all domestic rights, including marketing and manufacturing rights, for Januvia products to Chong Kun Dang in July 2023, transferring exclusive sales and marketing authority," and added, "Accordingly, Chong Kun Dang is responsible for price difference compensation due to drug price reductions that occurred after that point." Chong Kun Dang believes that it is unfair to transfer the responsibility for compensation when the marketing authorization holder had not been officially changed. Therefore, difficulties in negotiation are anticipated. The marketing authorization was indeed transferred to Chong Kun Dang on July 23, 2024, after which the business transitioned to a global direct import structure. An official from the Korea Pharmaceutical Distributors Association said, "As MSD Korea has delivered an official letter stating its position on compensation, Chong Kun Dang is also expected to clarify its stance soon," and added, "It is a desirable direction for both companies to clearly define their areas of responsibility and proceed with compensation." They further commented, "We suffered significant losses by not receiving price difference compensation for over a year. We faced severe difficulties in the middle, and we hope to find an amicable solution."
