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- 2026-04-11 21:14:16
- Company
- Yuhan invests ₩23.1B in Yuhan USA over 4 years
- by Chon, Seung-Hyun Aug 18, 2022 05:48am
- Yuhan Corp is making aggressive investments in its US subsidiary. Investing ₩23.1 billion during the past 4 years after establishing Yuhan USA in 2018, the company has been making broad steps to advance into the global market. According to the Financial Supervisory Service on the 17th, Yuhan Corp had invested ₩7.7 billion in Yuhan USA, and acquired 6 million shares in the second quarter of this year. Yuhan USA, which was established in 2018, is the regional subsidiary of Yuhan Corp that is responsible for investing in promising bio-ventures, global clinical trials, and technology exports. As a fully-owned subsidiary of Yuhan Corp, it has been serving as the bridgehead for the company’s global advancement. Yuhan USA has two offices, one in the East, in Boston, and the other in the west, in San Diego. Boston is regarded as the mecca of the global bio-industry, and San Diego is also a rising major bio cluster. An official from Yuhan said, “Yuhan USA has been serving as a bridgehead for the company, strengthening R&D capabilities by quickly acquiring advanced information by engaging in active networking activities in the US for delivery to Yuhan’s Central Research Institute.” Yuhan USA visits local companies, research labs, and universities in the US to directly invest in promising technology and new drug candidates. It also makes indirect investments in bio venture funds in the US and established its own fund to attract local bio-ventures and investors to visit Yuhan USA. The company also directly licensed out Yuhan’s gastroesophageal reflux disease (GERD) treatment in 2020. Yuhan licensed out its GERD treatment candidate 'YH12852' to Processa Pharmaceutical in August 2020 for the exclusive rights to its development, manufacture, and commercialization worldwide, except for Korea. The amount totals a maximum of $408.5 million (₩500 billion). Yuhan had received $2 million of Processa common stock as a non-refundable, non-creditable upfront payment. Processa Pharmaceutical is an R&D specialized company headquartered in Maryland, US that was founded in 2016. Yuhan USA had directly sought technology export partners and conducted negotiations in the US, and made the final deal with Processa Pharmaceutical. Yuhan USA also took part in increasing the possibility of technology exports for Yuhan's new drug candidates by attending major international conferences in the U.S. and introducing their clinical data. At the American Association for Cancer Research (AACR) meeting that was held in April this year, Taewon Yoon, CEO of Yuhan USA, personally attended and presented preclinical data on the company's immuno-oncology drug candidate 'YH32367.' Yuhan had first invested ₩1.9 billion in Yuhan USA upon its establishment in 2018. Since then, the company additionally invested ₩3.5 billion and ₩3.6 billion in 2019 and 2020, respectively, and then ₩6.4 billion last year. With this year’s investment, the total amount sums up to ₩23.1 billion in 4 years. The company is speeding up global market entry by increasing the investment amount every year. Yuhan USA has also been contributing to the development of ‘lasertinib,’ Yuhan’s key technology export project. Yuhan had made a licensing deal with Janssen bBotech for its EGFR targeted therapy ‘lasertinib’ in November 2018. Including the upfront payment of $50 million with no obligation of return, the company will receive a maximum of $1.205 billion under the deal. Yuhan USA is said to be continuously exchanging with its partner Jansen for the commercialization of lasertinib. After making the deal for lasertinib, Janssen has been actively developing the candidate in combination with its self-developed bispecific antibody ‘amivantamab.’ The CHRYSALIS study, the first study initiated by Janssen using lasertinib, is known to be in smooth progress. The study is not only investigating the ‘leclaza+amivantamab’ combination but its combination with platinum-based anticancer therapies such as ‘carboplatin,’ and ‘pemetrexed,’ etc. Yuhan has been making aggressive investments to reinforce the capabilities of its subsidiaries. Yuhan had invested ₩12.3 billion in Yuhan Care since last year. After acquiring 1,469,768 shares of Yuhan Care for ₩5.4 billion, it additionally invested ₩6.9 billion in Q1 this year. Yuhan also invested ₩21.4 billion and ₩0.9 billion last year and this year, respectively, in its IV product subsidiary, MG. The funds Yuhan invested in MG were used for the expansion and improvement of the company’s IV facilities.
- Opinion
- [Reporter's view] Legalization of Non-face-to-face Care
- by Lee, Jeong-Hwan Aug 18, 2022 05:48am
- Non-face-to-face treatment has become a social topic beyond the health and medical community. Non-face-to-face treatment, which has been temporarily allowed since February 2020, has been on the rise for three years, and the public and domestic medical systems, which are users, have naturally become accustomed to non-face-to-face treatment. Non-face-to-face treatment, which has become a hot topic, is now beyond temporary permission and the need for legislation is emerging. This is because the current medical law and pharmaceutical law principles are shaking due to excessive expediency and some illegal acts of non-face-to-face treatment platform companies derived from temporary permission. The Ministry of Health and Welfare recently reiterated its willingness to institutionalize non-face-to-face treatment to the National Assembly's Health and Welfare Committee and submitted a position to strongly control illegal attempts by delivery pharmacies or non-face-to-face treatment platform companies. The Ministry of Health and Welfare plans to start legislating within the year based on the non-face-to-face treatment bill pending in the National Assembly, and believes that the current face-to-face treatment alone cannot solve the problem of access to medical services such as islands and wallpaper. One more thing is needed to strengthen the legislation of non-face-to-face care. It is an interest in non-face-to-face treatment of the power of the ruling people. Currently, two cases (Choi Hye-young, Kang Byeongwon) have been proposed in the main opposition Democratic Party of Korea alone, including the legislation of non-face-to-face treatment. Shin Hyun-young, the main opposition Democratic Party, also announced plans to propose additional non-face-to-face treatment bills. In the power of the people, the non-face-to-face treatment bill has not yet been proposed. The Ministry of Health and Welfare and the Democratic Party are waiting for the ruling party's representative to propose a bill to strengthen the legislation of non-face-to-face care, but no lawmaker is reportedly interested in the bill yet. Non-face-to-face treatment should start discussions on legislation to strengthen the management of platform companies and the current medical law and pharmacology law principles at the same time as the need to stipulate the system itself as a law. At a time when the number of users of non-face-to-face treatment and non-face-to-face treatment services is exploding, there may be many side effects that need not be experienced if related regulations are established too late. Starting with the representative presentation of the non-face-to-face treatment bill, the ruling party should make efforts to improve legislative completeness by widely accepting the needs of the Ministry of Health and Welfare, the medical community, the Pharmaceutical Association, and the platform companies. It is a way to improve the stability of the health care industry and to prevent the principles of medical law and pharmacology law from being disturbed. It is expected that the ruling party will make an agile move to prevent platform companies from making mistakes in shaking the domestic health care system by neglecting non-face-to-face treatment with some expedient and illegal methods.
- Policy
- KDCA opposes use of Paxlovid in healthy 50s
- by Lee, Jeong-Hwan Aug 18, 2022 05:48am
- The disease control and prevention authorities have expressed opposition to the plan to lower the prescription age for Pfizer’s oral COVID-19 treatment, Paxlovid, to those in their 50s, on grounds of domestic Emergency Use Authorization standards. The decision was influenced by the fact that eligibility for Paxlovid had already been extended to those over the age of 50 with underlying diseases and that no efficacy evaluation results exist for its use in healthy adults in their 50s. On the 16th, the Korea Disease Control and Prevention Agency said, “Paxlovid can be prescribed to patients aged 12 years or older including those in their 50s that have risk factors such as underlying diseases.” NA Health and Welfare Committee member Jong-Seong Lee of the People Power Party had pointed out the need to review lowering the prescription age for Paxlovid to those in their 50s. Paxlovid is currently granted emergency use without an official marketing authorization in Korea. Under the EUA, patients who are confirmed with mild-to-moderate COVID-19 and are at high risk for progression to severe disease must satisfy additional standards to receive Paxlovid. The patient must additionally satisfy one or more of the following standards: 60 years or older who are immunocompromised, or 40 years or older with underlying diseases (diabetes, cardiovascular diseases, chronic kidney diseases, chronic lung disease, BMI over 30kg/㎡) The KDCA, which made the decision to expand Paxlovid’s eligibility to those in their 50s with underlying diseases in February (effective from February 7th), expressed skepticism on increasing the scope to those in their 50s who do not have underlying diseases. The KDCA said, “The subjects eligible for Paxlovid's use were set based on the efficacy evaluations results within the Emergency Use Authorization granted by the Ministry of Food and Drug Safety, in patients with risk for progression to severe disease because Paxlovid was found effective in the set target group.” The KDCA added, “Also, if a patient has risk factors such as underlying diseases, etc.. patients not only over the age of 50 but those who are 12 years or older may be prescribed Paxlovid.”
- Policy
- Why is price different btw patent-expired original/generic
- by Lee, Tak-Sun Aug 18, 2022 05:47am
- The drug price will be lowered to 53.55% of the existing upper limit from the 22nd after losing an administrative lawsuit against the drug price lowered by the anticoagulant Xarelto with the government. As a result, it will be the same as the highest price of generics registered last year. However, the drug price of Xarelto 10mg is expected to be about 20 won higher than the original. What is the reason? First, Xarelto 10mg immediately before generic registration was higher in drug price than Xarelto 15mg or Xarelto 20mg. The original three dosages were the same at 2,626 won at the time of initial registration, but just before the generic registration in July last year, the price of Xarelto 10mg was 2,487 won for Xarelto 15mg and Xarelto 20mg was 2,450. This seems to be a strategy to increase the main capacity of 10mg more. However, as the original low dosage exceeded the high-capacity drug price, the generic drug price needed to be adjusted. This is because the upper limit of low-doset products is calculated to be below the upper limit of high-content products if products with the same company, administration path, ingredients, and formulations are already listed. For this reason, the highest price of Xarelto's generic 10mg was registered at 1,312 won which is the same as Xarelto's generic 15mg and 20mg. The original Xarelto is reduced to 53.55% by calculation formula, making 15mg and 20mg the same as the generic high at 1,312 won, while 10mg becomes Xarelto 1,332 won. In 2012, the principle of patent expiration original-generic identification collapsed due to changes in drug price policy. Since the price difference between the original and generic is not large, the impact on the market is expected to be insignificant. In addition, if a generic that meets the standard requirements and registers only 10mg of Xarelto alone is released, the original upper limit is expected to be the same.
- Product
- Settlement of Xarelto price difference
- by Jung, Heung-Jun Aug 18, 2022 05:47am
- Some wholesalers are complaining at pharmacies as they demand that Xarelto, which will be lowered in drug prices, be returned by this week. This is because if the physical return is closed a week ago, there is no inventory to be prepared next week. In the case of Xarelto, wholesale companies seem to avoid returning on paper because the drug price reduction is large and the frequency is also an item. A pharmacist in Gyeongsangbuk-do said, "Large-sized products are intended to receive physical returns. "In fact, they don't believe in drugstore inventories, if so, I think we should provide the deadline for actual return as much as possible until just before the drug price cut." In online malls exclusively for pharmacies, many wholesalers have designated the deadline for actual returns until this week and are announcing it. Some pharmacies have already returned all the goods in accordance with the deadline guided by the wholesale company's manager. If a prescription comes next week, it will guide the patient to revisit. Pharmacist B in Seoul said, "I was told to return the actual product by this week, so I sent it all. "Only the full package is possible, and we proceeded according to the demand that all the divided cases should be filled," he said. " I think we should guide patients to revisit." Still, I can't help feeling anxious," he said. The situation was the same at a pharmacy in front of a general hospital with high frequency of prescriptions. Pharmacists have also contacted pharmaceutical companies to protest, but it is pointed out that the return problem has not been resolved. Pharmacy C, located in front of the general hospital, said, "We were informed that we could not request a physical return until this week and receive compensation for the individual pills. Next week, he also called the pharmaceutical company to protest because it was impossible to manufacture. We haven't received a response yet. Bayer said it was preparing to receive compensation for the drug price, but explained that it had never set a return deadline until this week and informed wholesaler by this week. Bayer said, "We are preparing to compensate for drug prices. Individual compensation is also possible. We did not inform wholesalers of the return deadline until this week.
- Opinion
- [Reporter’s View] Industry sullen over revised PE exemption
- by Eo, Yun-Ho Aug 17, 2022 05:52am
- The pharmaceutical industry is sullen despite the government's announcement of a measure to expand drug coverage, as the so-called measures for expanded coverage are closer to reductions from the industry’s point of view. The main issue lies in the improvement of the pharmacoeconomic evaluation (PE) exemption system that was included in the “Measure to improve patient access and reinforce reimbursement management for high-priced severe disease treatments” that was recently presented by the government. The goal of the improvement is to expand coverage for the pediatric patients. The government added a clause allowing PE exemption for "drugs used to treat pediatric patients that are therapeutically equivalent or has no available treatment option, and demonstrates improvement in quality of life or is otherwise approved by the committee." The added clause excluded the “life-threatening disease” condition required for PE exemptions in pediatric patients. In other words, if drugs used for pediatric patients satisfy the remaining conditions, the PE exemption may be applied even if the condition is not life-threatening. On the surface, it seems like an encouraging improvement. Many multinational pharmaceutical companies and the Korean Research-based Pharmaceutical Industry Association have been requesting the ‘life-threatening’ condition be removed from the eligibility criteria for PE exemptions. In this sense, this exclusion, although limited to pediatric patients, is a valuable step forward. However, a major premise for PE exemptions had also been revised. The government had added the phrase “a small number of eligible patients ” in the revision. This condition had previously been an “OR clause" included in Article 2c of eligibility for PE exemption regulations, along with other clauses such as ‘if a single-arm study was conducted,’ etc. In other words, if the amendment is applied in the current state, all drugs that wish to take the PE exemption track would have to have a small number of patients (as defined as 200 in the current criteria) and receive recognition from the committee for its difficulty in producing evidence to satisfy Article 2c of the regulation. Multinational pharmaceutical companies have been criticizing that this has narrowed the pathway for PE exemptions rather than expanding it. In fact, the KRPIA had issued a statement immediately after the government announced the revision, criticizing that the amended measure “overlooks the fact that it can demotivate companies from developing innovative new drugs and impede access to severe rare disease treatments.” Although such industry complaints are common following government policy announcements, considering the fact that the new government promised prompt listing of anticancer and rare disease drugs upon inauguration, and the non-reimbursed blind spots still exist for drugs that apply for special exemptions, the government needs to consider whether this revision is achieving its original purpose.
- Policy
- KDCA will announce its plan to inoculate bivalent vaccine
- by Lee, Jeong-Hwan Aug 17, 2022 05:52am
- The domestic quarantine authorities plan to announce vaccination plans at the end of this month, including the subject and use of Moderna's bivalent vaccine for COVID-19 omicron. Moderna bivalent vaccine is still in the pre-application stage, and the intention is to make a plan for use in consideration of the effectiveness and safety of vaccines as well as the quarantine situation and the amount introduced in Korea. Baek Kyung-ran, head of the Korea Centers for Disease Control and Prevention, answered reporters' questions at a regular briefing on COVID-19 on the 16th. Moderna's bivalent vaccine "Moderna COVID-19 Spikevax," called the Omicron vaccine, has been officially approved by British health authorities for the first time in the world on the 15th (local time). Specifically, MHRA conditionally approved the use of Moderna bivalent vaccine for additional inoculations (booster shots) for adults. This is the first time that the Omicron variant COVID-19 vaccine has been officially approved by a government agency. The vaccine is effective in preventing both the early round virus that caused the COVID-19 pandemic. Korea is conducting a preliminary evaluation of Moderna bivalent vaccine, and plans to announce a domestic vaccination plan as soon as the official approval review is conducted. Director Baek Kyung-ran said, "We are currently conducting a preliminary evaluation at the request of Moderna regarding Moderna bivalent vaccine. We haven't started any formal deliberations yet," she said. As soon as the review application proceeds, we will announce the use plan at the end of August, considering the effectiveness and safety of the improved vaccine, as well as the quarantine situation, introduction schedule, and quantity.
- Company
- Sanofi to supply flu vaccine Vaxigrip Tetra Nationwide
- by Aug 17, 2022 05:52am
- Sanofi's Korean subsidiary announced on the 16th that it has supplied its flu vaccine Vaxigrip Tetra nationwide on the 10th to mark this year's flu vaccination season. Sanofi supplied its flu vaccine earlier than usual so that those who need vaccinations can be vaccinated safely and effectively in preparation for the 2022-2023 seasonal flu epidemic. Accordingly, Vaxigrip Tetra can be inoculated at public health centers, consignment medical institutions, and major hospitals and clinics nationwide. Vaxigrip Tetra confirmed immunity and safety profiles through a total of six large-scale global clinical trials (four continents including Europe, Asia, South America, and Oceania) involving more than 13,000 people at all ages, including high-risk groups for influenza such as children, pregnant women, underlying diseases, and the elderly. It is the only quadrivalent flu vaccine that has a vaccination efficacy and safety profile targeting only infants, cardiovascular disease patients, and pregnant women. "With the flu epidemic becoming a reality in southern hemisphere countries such as Australia, the flu epidemic is also feared in Korea," said Woo Jae-kyung, general manager of the Korean company's influenza division. "As the COVID-19 pandemic has not spread over the past two years, natural immunity is likely to be reduced and the flu-sensitive population is more important this season."
- Policy
- Novavax vaccine approved for use for 12+ years in Korea
- by Lee, Hye-Kyung Aug 17, 2022 05:52am
- The age eligibility of Novavax’s COVID-19 vaccine will be extended. The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) announced that it had approved the Post Approval Change Application for the COVID-19 vaccine ‘Nuvaxovid Prefilled Syringe,’ developed by Novavax and manufactured by SK Bioscience, to change the vaccination age from the previous 18 years older to 12 years or older. Nuvaxovid in teens aged 12 to 17 years will be administered as two 0.5ml doses three weeks apart, the same as the dosage and administration approved for those aged 18 years and older. The MFDS determined it was appropriate to extend the allowed age of administration for Nuvaxovid based on clinical data from a trial conducted on adolescents aged 12 through 17 years. Trial results showed that adverse events observed in those aged 12-17 after receiving Nuvaxovid were generally similar to those in people aged 18 years and older, and were well-tolerated. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, malaise, nausea, arthralgia, etc. The symptoms were mostly mild or moderate and disappeared within a few days after vaccination. Nuvaxovid showed a 79.5% preventive effect on 1799 subjects (1,205 in the vaccine group, 594 in the placebo group), 6 of which in the vaccine group and 14 in the placebo group were confirmed with COVID-19, 7 days after the second vaccination. Also, the neutralizing antibody titer in 400 subjects who were not infected with COVID-19 two weeks after the second vaccination showed that the neutralizing antibody titer of those aged 12 to 17 (390 people) was 1.46 times that of those aged 18-25 (416 people), meeting the required standard. The MFDS said, “We will continue making our best efforts to provide safe and effective vaccines to our people.”
- Policy
- Generic exclusivity of Ticagrelor terminated but no benefits
- by Lee, Tak-Sun Aug 16, 2022 05:47am
- Brilinta, original for Ticagrelor Anti-thrombotic Ticagrelor have disappeared, but no news of generic benefit has been heard. Since the expiration of material patents in November last year, six pharmaceutical companies, including Chong Kun Dang, have registered their benefits, but pharmaceutical companies that have obtained generic exclusivity or later approved have been hesitant to register their benefits. This is because manufacturing costs are high and marketability is insufficient. According to the industry on the 13th, the general exclusivity period of Ticagrelor's generic will end on the 20th.No pharmaceutical company has applied for benefits on the premise of sales since that day. Ticagrelor's original drug is Brilinta of AstraZeneca. The drug expired its material patent on November 20 last year, allowing generics to enter the market after succeeding in subsequent patent challenges. Contrary to expectations, only six pharmaceutical companies registered their benefits at the time. They include Chong Kun Dang, Genuonescience, Samjin, Hana, Alvogen, and Hutecs. Like them, there were 18 more pharmaceutical companies that succeeded in subsequent patent challenges and obtained generic for exclusivity, but they did not register their benefits. This is because raw material prices are expensive and marketability is insufficient. They were also excluded from the generic for exclusivity list. An industry official said, "It is analyzed that the growth potential is not high as existing anti-thrombotic drugs competing with Ticagrelor are in good shape." "There are many companies that are worried about the balance of payments due to the high cost of raw materials," he said. Last year, the original Brilinta recorded 9.7 billion won in outpatient prescriptions based on UBIST. Pharmaceutical companies that failed to acquire generic for exclusivity have also received permission, but there is no movement to register their benefits. Even after the generic for exclusivity period is over, products can be sold only when the original drug patent challenge is successful, but few companies are active. Currently, 41 Ticagrelor generic companies are licensed, but none of them are seen in pharmaceutical companies that are considering entering the market except Chong Kun Dang, which is licensed for salt change drugs. Even Hanmi Pharmaceutical, Yooyoung and Korea Prime dropped their licenses this year. Some companies are said to have applied for and withdrawn their benefits.
