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- 2025-12-23 03:28:05
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- Roche’s Kadcyla sales KRW 70 bil…unrivaled lead in ADC mkt
- by Nho, Byung Chul May 28, 2024 05:52am
- Roche’s Kadcyla continues to remain the unrivaled lead in the domestic ADC (Antibody-Drug Conjugate) drug market, accounting for 60% share of the KRW 120 billion market. Based on drug distribution performance, the domestic ADC drug market was valued at KRW 113.8 billion last year, of which Kadcyla (treatment for HER2-positive metastatic breast cancer) accounted for KRW 75.8 billion, maintaining the top rank in the market ever since its launch. Kadcyla’s sales in 2019, 2020, 2021, and 2022 were in the range of KRW 35.4 billion, KRW 43.5 billion, KRW 52.7 billion, and KRW 51.8 billion, respectively. In second place is Daiichi Sankyo's Enhertu (treatment for HER2-positive breast cancer), which posted KRW 20.4 billion last year. Takeda's Adcetris (Hodgkin's lymphoma) and Pfizer's Besponsa (lymphoblastic leukemia) are on an upward curve, posting sales of KRW 9.8 billion and KRW 5.5 billion each in 2023. Sales of Astellas’ Padcev (metastatic urothelial carcinoma), Roche’s Polivy (B-cell lymphoma), Pfizer’s Mylotarg (myeloid leukemia), and Gilead’s Troldelvy (triple-negative breast cancer) remain in the KRW 400 to 900 range. Meanwhile, Kadcyla is regarded as Roche's defense or alternative to the inflow of Herceptin biosimilar and is a targeted anti-cancer drug that links Herceptin (trastuzumab) antibody to a taxane-based anticancer drug. Its prescribing strengths include prolonged survival (6 months longer in clinical trials) and minimized side effects. A global research firm (Motley Fool) has recognized Kadcyla’s product power and rated it as one of the world's top 7 drugs, along with Eliquis and Tecfidera. Enhertu is known to have overcome the limitations of existing therapies and is effective across solid tumors, not just in one indication. Earlier last month, the US FDA approved Enhertu as a tumor-agnostic treatment, of any type, allowing the drug to be used in patients with HER2-positive solid tumors with an immunohistochemistry (IHC) score of 3 or higher. The global ADC drug market has more than doubled in 3 years, from KRW 4 trillion in 2019 to KRW 13 trillion in 2023, and is expected to reach KRW 41 trillion by 2028. Since the first ADC, Pfizer's Mylotarg, was approved by the FDA in 2000, 13 ADCs have been introduced to the market. Pfizer acquired Seagen, a leader in the ADC field, late last year for USD 59 trillion to pave the way in ADC. Gilead Sciences also acquired Immunomedics in September 2020 for USD 29 trillion. Through the acquisition, the company acquired Immunomedics’ ADC development technology and FDA-approved ADC therapies.
- Company
- ‘Amgen’s success is based on its people and culture’
- by Eo, Yun-Ho May 28, 2024 05:52am
- Amgen is a well-versed player in the industry. Not only is it the leading global biotechnology company, but the company seems to know how to change its form to suit its environment, just like how Amgen Korea adjusts to Korea. Since entering Korea in 2015, Amgen has added 6 of its launched products to the reimbursement list, including its osteoporosis drugs Prolia (denosumab) and Evenity (romosozumab), skeletal-related event prevention drug Xgeva (denosumab), dyslipidemia drug Repatha (evolocumab), acute leukemia drug Blincyto (blinatumomab), and multiple myeloma drug Kyprolis (carfilzomib). In addition, the company is actively working to expand coverage by adding indications for each drug. Each of these launches had its challenges, given the Korean reimbursement landscape, but Amgen Korea showed its unique focus and perseverance and completed negotiations with the government. All of the drugs mentioned above are now leading their respective markets. In baseball, the same pitcher has different wins depending on which team he is on. Like this, part of the drugs’ success can be attributed to the good drugs, but the remaining parts certainly have something to do with the company’s strong suit. What kind of benefits would employees of such a company enjoy? Dailypharm met with Terry (Tae Hee) Yoon, 48, who oversees Amgen's People & Organization (P&O), to learn about the company's vision, talent, and welfare. Terry (Tae Hee) Yoon, Head of People & Organization at Amgen Korea -Amgen Korea has been making remarkable achievements. What are Amgen's strengths in terms of human resource management? Amgen was founded in 1980, which is not long compared to other multinational pharmaceutical companies, but it has a history of steady growth. Amgen Korea started small in 2015 and has grown to 180 employees. In terms of its presence in Korea, Amgen has been in operation for 40 years, and its Korean counterpart only 10 years, yet it has been able to quickly bring a variety of innovative medicines into the Korean market. The first reason for this success is that our business strategy is realistic, very organized, and strategic. Chasing short-term growth can lead to greed, but rather, Amgen has systematically developed and executed a long-term strategy. The second strength is in its people. Amgen does a great job of hiring talent strategically and their retention. And they help these talented people advance their careers through internal promotions at the next step. Amgen doesn't just hire the best people from outside the company, we also help those who are already here thrive. -What is Amgen's idea of an ideal employee? We hire based on our four leadership attributes - Inspire, Accelerate, Integrate, and Adapt. Of course, we also look at the experience, skills, and qualifications of the person to do the described job. But at the end of the day, when we seek to hire, promote, or nurture an employee, we evaluate them based on our four leadership attributes. No matter how good a person is at their job, if they do not demonstrate or meet the behaviors that align with our four leadership attributes and our values, we don't think they are the right fit for Amgen. We look at performance, but we also look at behavior. -So if someone has shown good performance, but doesn't have the four leadership attributes, they may not get the job? It’s hard to tell if a candidate has the attributes from a simple interview. Leadership attributes are not yes or no questions, so we ask ‘proving questions’ to find out the current or past behaviors of the person based on the leadership attributes and determine how he or she handled the job, how he or she responded to situations, and how he or she would solve problems. In addition to these processes, we interview the person with the department, HR, and if necessary, the president, and then have a calibration meeting before hiring. This process ensures that we finally hire a candidate that each department agrees upon and that he or she has the right skills that align with Amgen's leadership attributes. - Interest has been rising among college students in pursuing careers in multinational pharmaceutical companies lately. Despite the fact that there are only a few openings a year and the door is narrow, not only pharmacy students but also general college students are showing interest. Every experience counts. Also, working at a local company does not reduce the chance of working at a multinational pharmaceutical company, and having a lot of experience abroad doesn't give you a free pass to Amgen either. Many of our most experienced employees come to Amgen after accumulating experience in domestic pharmaceutical companies. Recently, Amgen signed an MOU with the College of Pharmacy at CHA University to allow students to gain experience working as interns. My advice to new graduates or undergraduates is to accumulate experience and build your own unique profile. Rather than obsessing over one company and thinking, "It's either this company or nothing," I want people to be prepared by accumulating a variety of experiences. Amgen doesn't have a large recruitment scale and is hiring on a rolling basis, so I think it's good to accumulate experiences whether small or large to prepare. -It seems like there is a lot of demand within the company as well to gain experience in different tasks and positions. I know Amgen has a STAR program. Amgen Korea's STAR (Short Term Assignment Resource) program allows employees to understand and experience the work of various departments within the company, and develop a future career that matches their potential capabilities as well as their ability to collaborate and communicate with employees from other departments. I think it's great that the company provides diversity so that people's diverse abilities are not buried and can be brought out through new opportunities. Of course, not all employees who take part in the program transfer to different positions. Some employees decide that it's better to stay in their current position after experiencing the STAR program, while others change departments. – Approximately what percentage of the employees seek to change their position? It varies from person to person. We prioritize those who have a desire to change their position, but ultimately, the company needs to identify the core positions it needs. What you want to do and what you're good at can be different, so we try to identify the positions first and then build the talent pipeline pool to fit those positions. -How does Amgen evaluate its employees? Amgen has a system called MAP (Maximizing Amgen Performance). It's a five-point rating scale, and we evaluate three cycles: goal setting, mid-year, and year-end. But we limit the evaluations to just three times. In the case of the year-end evaluation system, the company's goals are shared with the vice presidents, who then share them with their employees and develop engagement scores and programs accordingly. The year-end review then evaluates the KPI part as well as leadership attributes. In terms of leadership attributes, HR helps facilitate workshops for teams, which are then internalized to individual employees to ensure objectivity and consistency. As part of the evaluation process, the leadership team has a formal calibration meeting with other departments to assess whether the employee's performance is aligned with the company’s leadership attributes in a multi-faceted way. Because of this process, I trust that my leaders and other collaborators can give me an objective, multi-faceted assessment of what I've worked hard on. With so many different departments involved, this process can be very sobering. You may be doing a great job, but there may be conflicts in a cross-functional context, and the department head would have blind spots. This evaluation may result in a downgrade, even if the head of the person’s department wants to give the person the highest possible rating. -What benefits do you offer to your employees that are unique to Amgen? During the pandemic, most pharmaceutical companies started remote working programs allowing employees to work from home for safety reasons. After the pandemic, most of these programs have been shut down, or are allowed to work from home only on dates that have been approved by managers. Amgen's Flex Space culture, both in Korea and globally, seems to have built a strong sense of trust between the company and employees. Amgen Korea has introduced Flex Space culture such as smart offices and Fun Friday, where employees can leave work early on the third Friday of every month to spend time with their families, encouraging employees to also focus on their lives outside of work. - Looking at your past activities, you seem to be focusing on 'family' in particular. Yes. One of the unique aspects of Amgen is our Family Friendly Certification, which we received in 2022. The average age of our employees is in their early 40s, which is very young, and is an age when there are a lot of family concerns, including childcare. The employee resource group (ERG) program is also based on this. Our employees are highly engaged in the company, driven by our bottom-up culture, rather than from the top down. Our ERG program is one example of this. This year, we'll be inviting families to the office to introduce and showcase the company their parents or children work for. - What else would you like to introduce about your company? Amgen is a company that has grown and will continue to grow. It's a great place to work for women, with 70% of our executives being women, and we have a systematic career development program in place for talented people of all genders, and many opportunities for local talent to expand their roles into global. One such program is Thrive, which is run in the Asia Pacific region. The Thrive program has been and will continue to be an opportunity for candidates to expand their work experience in other Asian regions after a selection process. There are also opportunities for employees to work on projects with people in Region, even if you're not directly working overseas.
- Company
- Global pharmaceutical companies acquire radiopharmaceuticals
- by Son, Hyung-Min May 28, 2024 05:52am
- The high interest in radiopharmaceuticals has led to investments by pharmaceutical companies. Last year and this year, Lily invested KRW 3.5 trillion in a company developing radiopharmaceuticals. Global pharmaceutical companies, including AstraZeneca, Novartis, and BMS, have acquired companies developing radiopharmaceuticals and entered the market. In South Korea, FutureChem and Dong-A ST are also developing radiopharmaceuticals and exploring opportunities for technology transfer and commercialization potential. Radiopharmaceuticals work by delivering radioactive isotopes into the body, and then the isotopes release radio waves when reaching cancer cells, destroying cancer organs. Radiopharmaceuticals are divided up by diagnosis and treatment markets, with the diagnosis market having over 90%. The major pharmaceutical industry is focused on the radiopharmaceuticals diagnosis market and the treatment market, which represents a blue ocean opportunity. According to industry sources on May 28th, Lily signed a co-development deal with Aktis Oncology, a company specializing in radiopharmaceuticals. Through this contract, Lily has acquired the right to commercialize a part of Aktis’ developing products for diagnosis. Lily will pay Aktis up to US$1.1 billion as it achieves future milestones, including a $60 million upfront payment. Following the acquisition of POINT Biopharma and the development of biopharmaceuticals with Aktis, Lily demonstrated a focus on the industry. Lily invested US$1.4 billion (approximately KRW 2 trillion) in acquiring POINT Biopharma’s PNT2022, a prostate cancer treatment candidate, and PNT2003, a neuroendocrine tumor treatment candidate. Global pharmaceutical companies, including Lily, Novartis, AZ, and BMS, enter radiopharmaceuticals development. Novartis also completed the acquisition of a company specializing in developing radiopharmaceuticals. Novartis succeeded in acquiring Mariana Oncology of the United States. The contract size was up to US$1.75 billion. Through this acquisition, Novartis secured MC-339, an actinium-based radioligand therapy (RLT). MC-339 is under clinical trials for indication in small-cell lung cancer. Radioligand is a treatment that conjugates therapeutic radioisotope with a targeted ligand. When the therapeutic radioisotope binds to targeted cells, the radioisotope is released, inhibiting the cancer cell growth. Novartis plans to expand its radiopharmaceuticals pipeline. Last month, Novartis signed a co-development agreement with Japan’s pharmaceutical company PeptiDream. PeptiDream has PDC (peptide-drug conjugate) technology, which conjugates a peptide to radionucleotides. In addition to having prostate cancer treatment Pluvicto and neuroendocrine tumor treatment Lutathera, Novartis aims to secure additional novel drugs. AstraZeneca and BMS also initiated radiopharmaceuticals development. In March last year, AstraZeneca acquired Fusion Pharmaceuticals, a Canadian company developing radiopharmaceuticals. AstraZeneca secured FPI-2265, a novel candidate for treating metastatic prostate cancer. FPI-2265, targeting prostate-specific membrane antigen (PSMA), is under phase 2 clinical trials. FPI-2068, a EGFR-cMET targeting radioconjugate, also entered a Phase 1 study. In December, BMS acquired RayzeBio, a company specializing in radiopharmaceuticals, for approximately US$4.1 billion. RayzeBio is developing radiopharmaceuticals that target a wide range of solid cancers, including gastroenteropancreatic neuroendocrine tumors (GEP-NET). Its primary pipeline includes GEP-NET, RYZ101, which targets somatostatin receptor 2 (SSRT2) overexpressed in small-cell lung cancer, and RYZ801, targeting glypican-3 (GPC3). Attention↑ in South Korea…FutureChem entered a Phase 2a study As global pharmaceutical companies show high interest in radiopharmaceuticals, opportunities for domestic biopharmaceutical companies to transfer technology may be on the horizon. Currently, FutureChem is evaluated to be at the foremost stage of development. This month, FutureChem initiated the first administration of FC705, targeting castration-resistant prostate cancer (CRPC), in a patient as part of its Phase 2a study in the United States. FC705 is a radiopharmaceutical targeting PSMA, which is overexpressed in prostate cancer cell surfaces. This treatment is based on a PSMA-binding peptide conjugated with a therapeutic radioisotope, which kills the cancer cells. In Phase 1 clinical trials, all the patients treated with FC705 met overall response rates (ORR) and disease control rates (DCR). FutureChem is conducting a Phase 2 trial in South Korea, in addition to its U.S. clinical trials and is under discussion for technology transfer with China. AbTis, a Dong-A ST’s subsidiary, will start novel radiopharmaceuticals development with CellBion. Last month, two companies signed a co-development agreement. Utilizing AbTis’ AbClick, a linker platform technology, and CellBion’s linker technology of radiopharmaceuticals, they plan to develop a novel Antibody-Radionuclide Conjugate (ARC) targeting gastric cancer and pancreatic cancer. AbTis plans to use Ac-225, a strong therapeutic radioisotope, and cooperate in clinical, production, and commercialization. SK Biopharmaceuticals designated radiopharmaceuticals as one of three new modalities and aims to enter clinical trials within three years. In September last year, SK Biopharmaceuticals signed a business agreement with the Korea Institute of Radiological & Medical Sciences (KIRAMS) for novel drug study, clinical development utilizing actinium-225 (Ac-225), the key ingredient of radiopharmaceuticals, and constructing related facilities.
- Company
- Leclaza demonstrates efficacy as combo therapy in NSCLC
- by Son, Hyung-Min May 27, 2024 05:48am
- Clinical data demonstrating the efficacy of the Leclaza and Rybrevant combination in lung cancer will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting. An abstract published for the ASCO 2024 Annual Meeting (ASCO 2024), a five-day conference that is set to start on the 31st, confirmed the additional efficacy of the combination therapy. In addition to the primary endpoint results for the combination announced last year, the abstract confirmed the drug’s efficacy in rare types of mutations, giving the combination a green light for its entry into the global new drug market. Johnson & Johnson (J&J), which holds the global rights to both treatments, filed for the combination’s approval as a first-line treatment for EGFR-positive NSCLC to the U.S. Food and Drug Administration (FDA) last December. According to industry sources on the 25th, abstracts of the results of the Phase III MARIPOSA follow-up study of Leclaza and Rybrevant were released on the 25th. Leclaza is Yuhan Corp’s treatment for non-small cell lung cancer that targets the epidermal growth factor receptor (EGFR) mutations exon 19 deletion and exon 21 (L858R). The company has been testing the drug’s potential in combination with Rybrevant, Janssen's EGFR exon 20 mutation-targeting NSCLC drug, in NSCLC. The MARIPOSA trial evaluated Leclaza and Rybrevant’s efficacy in patients with EGFR-positive locally advanced or metastatic NSCLC. Results that were presented last year showed that the combination improved overall survival (OS) and reduced the risk of disease progression and death by 30% compared with Tagrisso. At the upcoming ASCO meeting, the results of a subgroup analysis that evaluated the combination’s efficacy in high-risk groups, including patients with TP53 mutation, circulating tumor DNA (ctDNA), and brain or liver metastases, will be presented. TP53 mutations are present in various cancers, including lung and liver cancers, and the inactivation of TP53 is known to be associated with malignant lung cancer. 636 patients with treatment-naïve EGFR-positive exon 19 del or exon 21 mutated NSCLC enrolled in the study. Based on an analysis of 636 evaluable patients, patients treated with Leclaza+Rybrevant achieved a median progression-free survival (PFS) of 18.2 months in patients with TP53-mutated NSCLC, which was longer than the 12.9 months achieved with Tagrisso monotherapy. In patients with detectable ctDNA at baseline, PFS was 20.3 months in the Leclaza+Rybrevant group, compared with 14.8 months in the Tagrisso monotherapy group. In patients with liver metastases, PFS was 18.2 months with the Leclaza+Rybrevant group versus 11.0 months with the Tagrisso monotherapy group. The researchers said, “Given that this high-risk biomarker population accounts for up to 85% of all EGFR-positive NSCLC patients, we believe that the Leclaza+Rybrevant combination may play an important role as a standard of care in first-line NSCLC.” Leclaza+Rybrevant demonstrates efficacy in rare-mutated types of lung cancer as well Yuhan Corp’s Leclaza and Janssen’s RybrevantThe Leclaza and Rybrevant combination also demonstrated efficacy in NSCLC harboring atypical mutations in the CHRYSALIS-2 study. The CHRYSALIS-2 study was initiated to identify biomarkers that are associated with higher response rates to the Leclaza+Rybrevant combination therapy. The Cohort C study that was presented this time evaluated the potential of the Leclaza+Rybrevant combination in treating NSCLC harboring atypical EGFR-positive mutations, excluding exon 20 insertion mutations (S768I, L861Q, and G719X). Cohort C of the CHRYSALIS-2 study enrolled patients with atypical EGFR mutations, excluding exon 20 insertion mutations, who were treatment-naïve or had two or fewer prior lines of therapy, which may have included a 1st/2nd-generation EGFR TKI. The median age was 64 years, and 68% of the patients were Asian. The most common mutations were G719X (54%), L861Q (24%), and S768I (22%). As of December 14, 2023, at a median 13.8 months of follow-up, the ORR was 51% in the treatment-naïve subset. The ORR for patients harboring solitary mutations at G719 (n = 13), L861 (n = 8), and S768 (n = 2) was 54%, 63%, and 100%, respectively. Among patients treated with prior Giotrif, the ORR was 45%. Up to now, the only drugs that have shown an effect in EGFR-positive variants, including G719X, L861Q, and S768I, have been Boehringer Ingelheim's Giotrif and AstraZeneca's Tagrisso. In this area that lacked treatment options, the combination of Leclaza and Rybrevant showed efficacy against rare EGFR-positive mutations, paving the way for the combination to become the standard of care for NSCLC. The details of the clinical results from the CHRYSALIS-2 cohort will be presented at the ASCO Abstract Session by Dr. Byoung Cheol Cho, Director of the Lung Cancer Center at Yonsei University Cancer Hospital.
- Company
- Bukwang subsidiary’s IPO in Korea will be postponed
- by Kim, Jin-Gu May 24, 2024 05:49am
- Bukwang Pharmaceutical announced that the IPO schedule for its subsidiary Contera Pharma would inevitably need to be postponed. Initially, Contera Pharma planned to gain momentum for its IPO listing in Korea and abroad based on the Phase II results of its new drug candidate for Parkinson's disease, JM-010, but the schedule was postponed as the drug failed to demonstrate statistical significance. However, the company had affirmed that it had not given up its plan to list Contera Pharma. Woo-hyun Lee, the Chairman of its parent company, OCI Holdings, is planning to visit Contera Pharma in Denmark this month to see firsthand the development progress of JM-010 and other portfolios. Je-Young Lee, CEO of Bukwang Pharmaceutical, held an online emergency briefing session on the morning of the 23rd to explain Contera Pharma's JM-010 clinical results and plans. Bukwang Pharmaceutical announced on May 22 that it did not meet the primary endpoint target in the European Phase II clinical trial of Contera Pharma's Parkinson's disease candidate JM-010. The primary endpoint was the reduction in dyskinesia as assessed by the Unified Dyskinesia Rating Scale (UDysRS) at Week 12. On this, CEO Lee said, "Although we confirmed the drug’s pharmacological effect, we were unable to confirm a statistically significant difference between JM-010 and the placebo, which was our primary endpoint. We are conducting additional subanalysis on our findings and have identified some significant results. We plan to announce the specifics at upcoming international academic conferences." However, regardless of the sub-analysis results, the company decided to discontinue the US trial. Lee explained, "Our initial strategy was to shorten the duration of the ongoing US Phase II trial and enter Phase III early based on the European Phase II trial results, but we had to give up this strategy due to failure to achieve statistical significance in the US trial. Further delays and additional investments are too burdensome. As painful as it is, we have decided to discontinue the US trial." As for Contera Pharma's IPO, the company said it will have to delay its timeline. CEO Lee said, “Our original plan for a quick IPO has become a little difficult, and we would inevitably have to postpone the listing.” “However, given Contera Pharma’s capabilities and other pipelines, it would be disappointing to give up on the listing itself.” Lee emphasized, “We are not suspending or abandoning the company’s IPO itself.” He also dismissed speculations and questions about whether the clinical trial failure would lead to a breakup of OCI Holdings and Bukwang Pharmaceutical, or Bukwang Pharmaceutical and Contera Pharma. CEO Lee said that he and OCI Holdings Chairman Woo-hyun Lee will visit Contera Pharma in Denmark this month to look at the company's pipeline. "Of course, it is true that JM-010 is a significant part of Contera Pharma, but OCI is constantly attempting to make its way into the pharmaceutical industry, and this result is unlikely to change OCI's policy on Bukwang Pharmaceutical." “Contera Pharma owns a number of other pipelines in addition to JM-010. We plan to visit Contera Pharma in Denmark with Chairman Lee at the end of May and plan to review the company's portfolio development situation there.”
- Company
- HLB·Jiangsu "FDA, facility issues not related to efficacy"
- by Son, Hyung-Min May 24, 2024 05:48am
- (from the left) Chief Technology Officer (CTO) Han Yong-hae of HLB Group, Vice President Frank Jiang of Jiangsu Hengrui Pharmaceuticals, CEO Jung Se-ho of Elevar Therapeutics, and Vice President Jang Sung-hoon of Elevar Therapeutics. "It appears that there are no issues related to the efficacy of Rivoceranib plus camrelizumab therapy. However, we were pointed out of the manufacturing facility during the monitoring of Jiangsu Hengrui Pharmaceuticals. We do not need an additional clinical trial. By closely cooperating with the U.S. FDA, we will introduce a novel drug to patients with liver cancer." HLB group and Jiangsu Hengrui Pharmaceuticals hosted a press conference on May 23rd at Sofitel Ambassador Seoul Hotel and stated this regarding the FDA’s rejection of approval for their novel candidate drug, Rivoceranib plus camrelizumab, for the treatment of liver cancer. The press conference was attended by Chief Technology Officer (CTO) Han Yong-hae of HLB Group, Vice President Frank Jiang of Jiangsu Hengrui Pharmaceuticals, CEO Jung Se-ho of Elevar Therapeutics, and Vice President Jang Sung-hoon of Elevar Therapeutics. HLB announced on the 17th that they received a complete response letter (CRL) request from the U.S. FDA regarding the application for Rivoceranib plus camrelizumab combination therapy as the first-line treatment for liver cancer. The main reason for receiving the CRL was reported to be issues raised during the Bioresearch Monitoring (BIMO) inspection, which aimed to verify the manufacturing facility and key clinical sites for camrelizumab initially. Jiangsu Hengrui Pharmaceuticals explained that it was due to facility issues. “This case of FDA’s rejection of approval was due to the facility issue,” Vice President Frank Jiang of Jiangsu Hengrui Pharmaceuticals said. “We expect to confirm the details at a future meeting. We will closely cooperate with the FDA and HLB.“ CTO Han Yong-hae of HLB Group said, “During the FDA inspection, some issues were raised regarding the manufacturing facility of camrelizumab, but Jiangsu Hengrui Pharmaceuticals diligently addressed the supplementation." He further mentioned, "Disparities between the examiner and examinee may exist. The FDA made no comments regarding efficacy and safety, and no additional clinical trials are needed.“ HLB and Jiangsu Hengrui Pharmaceuticals have been developing Rivoceranib plus camrelizumab combination therapy as a treatment for liver cancer and gastric cancer. Rivoceranib is an oral anticancer drug that selectively inhibits vascular endothelial growth factor receptor-2 (VEGFR2), which is involved in angiogenesis. Jiangsu Hengrui Pharmaceuticals’ camrelizumab inhibits PD-1 protein expressed on the surface of immune cells (T cells), preventing the binding to PD-L1 receptors on cancer cell surfaces, thereby activating immune cells. The CARES-310 Phase 3 clinical trials showed improved efficacy of Rivoceranib plus camrelizumab combination therapy compared to Bayer’s Nexabar, which is used as a standard therapy for liver cancer. In clinical trials, Rivoceranib plus camrelizumab recorded a median overall survival (OS) of 22.1 months, demonstrating an improvement compared to Nexabar’s 15.4 months. This result was more extended than the OS of 19.2 months recorded by Roche’s combination therapy of Tecentriq, an immunotherapy for cancer, plus Avastin, a targeted anticancer agent, for the first-line therapy of liver cancer. Furthermore, it is also extended than the OS of 16.4 months of AstraZeneca’s Imfinzi plus Imjudo combination therapy. These drugs were compared with Nexabar alone. However, the talks caution against comparing research results on the same basis. In the CARES-310 study, 83% of the patients were Asians, whereas in the IMbrave150 study of Tecentriq plus Avastin combination therapy, the proportion of Asians was 40%. The FDA has requested additional data for novel drug clinical trials focusing on specific races or countries. CTO Han Yong-hae of HLB Group said, "While there may be differences in efficacy between races in other cancer types, race is not a significant factor in first-line treatment for liver cancer," and added, "Updated results will be available at the American Society of Clinical Oncology (ASCO) meeting starting on the 31st of this month. I believe that with additional data, the combination therapy of Rivoceranib plus camrelizumab will receive more positive evaluation."
- Company
- Keytruda posts KRW 100 bil in quarterly sales
- by Chon, Seung-Hyun May 24, 2024 05:48am
- The immuno-oncology drug Keytruda has strengthened its dominance in the domestic drug market, maintaining quarterly sales in the KRW 100 billion range. After being granted reimbursement expansion as a first-line treatment, Keytruda’s sales surged even greater, tripling the sales gap with the runner-up in the market. Also, other new anticancer drugs from multinational pharmaceutical companies like Tagrisso and Imfinzi showed strong growth. According to the market research institution IQVIA on the 24th, sales of MSD Korea’s Keytruda led the market with sales of KRW 116.8 billion in Q1, up 33.1% YoY. This marks the 17th consecutive quarter that Keytruda has held the top spot in the domestic drug market since taking the top spot in Q1 2020. Keytruda, which was introduced to Korea in 2015, is an immune checkpoint inhibitor that inhibits PD-1 (programmed death 1) proteins expressed at the surface of activated T cells, thereby inhibiting its binding to PD-L1 and activates the immune system to treat cancer. The drug is currently approved for 16 cancers: ▲Lung cancer, ▲head and neck cancer, ▲ Hodgkin’s lymphoma, ▲urothelial carcinoma (bladder cancer), ▲esophageal cancer, ▲ melanoma, ▲renal cell cancer (kidney cancer), ▲endometrial cancer, ▲stomach cancer, ▲small intestine cancer, ▲ovarian cancer, ▲pancreatic cancer, ▲biliary tract cancer, ▲colorectal cancer ▲triple negative breast cancer, and ▲cervical cancer. It is indicated for the largest number of cancer types among cancer immunotherapies approved in Korea. It is reimbursed for 7 indications in 4 types of cancer – non-small-cell lung cancer, melanoma, urothelial carcinoma, and Hodgkin’s lymphoma. It is also reimbursed as a first-line treatment for melanoma and non-small-cell lung cancer. It has shown accelerated performance since its reimbursement was extended to the first line in 2022. In March 2022, Keytruda’s reimbursement was extended to cover first-line treatment for non-small cell lung cancer. Keytruda’s sales jumped 117.1% in one year, from KRW 40.4 billion in Q1 2022 to KRW 87.8 billion in Q1 last year. Its Q1 sales this year tripled compared to 2 years ago. Since exceeding sales of KRW 100 billion in Q3 last year, the drug has posted sales of over KRW 100 billion for 3 consecutive quarters. This is the first time a drug’s quarterly sales have surpassed KRW 100 billion in the domestic pharmaceutical market. Keytruda’s sales are nearly three times higher than the second place, Prolia. Keytruda's insurance ceiling price was lowered by 25.6% with the reimbursement expansion. Considering how sales had increased by twofold in Q1 compared to Q4 2021, before the reimbursement expansion, it is calculated that Keytruda’s prescriptions increased by over threefold during the period. Also, AstraZeneca’s anticancer drug Tagrisso has benefited from the reimbursement expansions this year. Q1 sales of Tagrisso were KRW 39.9 billion, up 46.0% YoY. Tagrisso is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). EGFR-TKIs are targeted anticancer drugs prescribed to patients with metastatic non-small cell lung cancer (NSCLC) with EGFR mutations. Tagrisso’s quarterly sales surpassed KRW 20 billion in Q1 2020 and remained in the KRW 20 billion range until Q4 last year. Beginning this year, Tagrisso, along with Yuhan Corp’s Leclaza, were granted reimbursement expansions as were covered as a first-line treatment for locally advanced or metastatic NSCLC with certain genetic mutations.’ Tagrisso reported sales of KRW 26.9 billion in Q4 last year, and sales jumped 47.9% in a single quarter after the reimbursement expansion. Health authorities estimate that Tagrisso's coverage as a first-line treatment will cost an additional KRW 92 billion, according to the Ministry of Health and Welfare. Yuhan Corp’s Leclaza’s sales more than tripled to KRW 18.9 billion in Q1 from KRW 6.2 billion in sales in Q4 last year. The MOHW analyzed that the reimbursement coverage of Leclaza as a first-line treatment will cost the nation an additional KRW 88.1 billion. New products recently launched by multinational pharmaceutical companies have also risen to prominence at the top of the domestic drug market. Amgen's Prolia ranked second overall with Q1 sales of KRW 41.2 billion, up 16.2% from the previous year. This is a 64.7% increase in 2 years from KRW 25 billion in Q1 2022. Launched in Korea in November 2016, Prolia is a biological osteoporosis treatment that targets the RANKL protein essential for the formation, activation, and survival of osteoclasts that destroy the bone. Its sales started to rise after it was applied reimbursement as a second-line treatment in 2017. After additionally being approved for reimbursement in the first line from April 2019, Prolia’s sales rose explosively. Prolia is copromoted by Chong Kun Dang in Korea. Sales of Sanofi’s atopic dermatitis treatment Dupixent rose 30.9% YoY to record KRW 40.5 billion in Q1. Dupixent is the first targeted biologic for the treatment of moderate-to-severe atopic dermatitis that is not well controlled with topical therapies or who cannot use topical therapies. Sales of Dupixent, which was approved in March 2018, increased rapidly after it was approved for reimbursement for severe atopic dermatitis in January 2020. Sales of the immuno-oncology drug Imfinzi increased 107.1% YoY to reach KRW 31.5 billion in Q1 this year. Imfinzi is a PD-1-targeted immuno-oncology drug developed by AstraZeneca. Imfinzi was the first immuno-oncology drug to demonstrate efficacy in biliary tract cancer. In 2022, AstraZeneca received approval for the combination of Imfinzi+gemcitabine+cisplatin in South Korea. The combination became the new standard of care for biliary tract cancer in 12 years. AstraZeneca is currently in the process of expanding reimbursement to the biliary tract cancer indication. Among domestically developed new drugs, HK Inno.N’s gastroesophageal reflux disease treatment K-CAB’s sales had risen 21.6% YoY in 1H to record KRW 32.2 billion, and rose to 6th place. K-CAB, was released in March 2019. It has a new mechanism of action that inhibits gastric acid secretion by competitively binding to the proton pump and potassium ion located in the final stage of acid secretion. Hanmi Pharmaceutical's hyperlipidemia combination drug Rosuzet ranked 10th overall with sales of KRW 29.3 billion in Q1. Rosuzet is a combination drug that contains rosuvastatin and ezetimibe.
- Company
- Pharmas face a heavy burden from high-interest loans
- by Kim, Jin-Gu May 24, 2024 05:48am
- Pharmaceutical and biotech companies’ bank loan interest rates have been set high for over two years. A high-interest rate, up to 8%, has been maintained, and key companies face a heavy burden from this. The pharmaceutical industry raises concerns that an extended financial burden due to high interest rates may decrease investment. Most big pharmaceutical companies with high loan ratios are currently focused on repaying loans while reducing thier investment sizes. Samsung Biologics’ Q1 interest expenses amount to KRW 16.1 billion…4-5% interest rate has been maintained for over 2 years According to the Financial Supervisory Service on May 23rd, Samsung Biologics’ loan amount by the end of Q1 amounts to KRW 16.1 billion. This amount decreased compared to KRW 21.7 billion in Q1 last year, but the company may be facing a heavy burden. Samsung Biologics borrowed KRW 572 billion in 1-year short-term loan from six banks, including Kookmin Bank. The interest rate is around 4.66-5.38%. The company also borrowed a long-term loan of KRW 425.4 billion, with KRW 350.4 billion due within a year. The interest rate for long-term loans is 1.55-5.74%. Furthermore, the amount of money that Samsung Biologics must repay KRW 1.3024 trillion within a year, including private loans. It appears that the company spent KRW 1.61 billion just on interest in Q1. The loan burden due to the high interest rate has continued for two consecutive years. Last year, Samsung Biologics spent KRW 81.6 billion on interest, and in 2022, the company had to pay KRW 64.1 billion in interest. These amounts are strikingly different from the previous years. In 2020 and 2021, the company paid KRW 16.1 billion and KRW 14.7 billion in interest, respectively. The recent increase in interest amount may be due to expanding the loan size for building of the new 4·5 manufacturing plant, but the analysis suggests that a higher interest rate may have played a part. In fact, the short-term and long-term loan interest rates were 1.50-2.70% until 2021. However, the interest rate significantly increased in 2022, up to 5%. After that, the high-interest rate has been maintained for over two years. Major pharmaceutical companies’ interest rates are up to 7%...due to the expanded interest amount burden, concerns arise about investment decline Other pharmaceutical and biotech companies are currently facing similar challenges. The companies are struggling to procure funds and investments due to accumulating burden of a high-interest rate, which can reach a maximum 7%. As of the end of Q1 last year, Yuhan’s short-term loan interest rate was 3.93-5.67%, and long-term loan interest rate was 3.00-6.30%. Last year’s short-term and long-term loan interest rates were around 2.20-7.70%. However, Yuhan’s loan interest rate was around 1.30-3.40% until 2021. GC Pharma had a short-term loan of KRW 248.3 billion with an interest rate of 4.47-6.46% as of the end of Q1 last year. This rate is similar to the 4.54%-6.45% of 2022. In 2021, GC Pharma’s loan interest rate was merely 1.60-3.80%. In Q1 this year, GC Pharma spent KRW 7.1 billion on interest. Its interest amount was KRW 10.6 billion in 2021 but significantly increased to KRW 15.6 billion and KRW 23.9 billion in 2022 and 2023, respectively. Hanmi Pharm’s short-term loan interest rate was 1.70-2.80% in 2021 but has increased to 2.70-6.3% in 2022. Its interest rate for last year and Q1 this year was 4.20-5.40%. Hanmi Pharm’s expense for interest amount has significantly increased from KRW 16.8 billion in 2021, KRW 28.5 billion in 2022, and KRW 22.6 billion in 2023. In Q1 this year, Hanmi Pharm spent KRW 7.3 billion just for the interest amount. Furthermore, other companies, including Daewoong Pharmaceutical, HK inno.N, Boryung, Dongkook, Ildong Pharmaceutical, Dong-A ST, and JW Pharmaceutical, have been burdened by a high-interest rate of 5-8% for more than two years. Ildong Pharmaceutical has up to 8% of short-term loan interest rate. Changes in loan interest rates of major pharmaceutical companies. Yuhan, GC Pharma, Hanmi, Daewoong Pharmaceutical, HK inno.N, Boryung, Jeil Pharm, JW Pharmaceutical, Ildong Pharmaceutical, and Dong-A ST (source: Financial Supervisory Service). The pharmaceutical companies say that more than two years of accumulating interest burden may lead to a decline in investment. For instance, Samsung Biologics has focused on repaying loans while cutting back on investment. The analysis suggests that this may be due to the company’s larger loan size, but the accumulated burden from the high interest rate may have played a role in part. The company's cash flow statement shows that the cash flow from investment activities decreased in size, from KRW 3.1065 trillion spent in 2022 to KRW 1.5663 trillion spent last year. This indicates that the investment spending decreased by almost half. On the other hand, the cash flow from financing activities amounted to an inflow of KRW 3 trillion in 2022, but it showed an outflow of KRW 635 billion last year. It indicates that while the company borrowed KRW 3 trillion from banks in 2022, it focused on repaying loans last year, resulting in an expenditure of KRW 635 billion. Other pharmaceutical and biotech companies have also been cautious about expanding investments recently. The industry anticipates this trend to persist for some time, partly due to the low probability of interest rate cuts by the Bank of Korea. As a result, the burden on pharmaceutical and biotech companies from high interest rates is expected to be extended.
- Company
- Enhertu gets expanded indications for NSCLC·breast cancer
- by Son, Hyung-Min May 23, 2024 05:49am
- Enhertu (trastuzumab deruxtecan) Daiichi-Sankyo Korea and AstraZeneca Korea announced that Enhertu (trastuzumab deruxtecan) received expanded indication for HER2-low metastatic breat cancer and metastatic non-small cell lung cancer (NSCLC) on May 20. Enhertu is now approved for treating ▲patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have previously undergone systemic therapy in the metastatic setting or relapsed within 6 months of completing adjuvant chemotherapy and hormone receptor-positive (HR+) patients who have received or are unsuitable for endocrine therapy ▲patients with unresectable or metastatic NSCLC with activated HER2 (ERBB2) mutations who have previously received systemic therapy, including platinum-based chemotherapy. The basis for this Enhertu’s expanded indication is DESTINY-Breast04 and DESTINY-Lung02 clinical trials DESTINY-Breast04 clinical trial compared the efficacy and safety of Enhertu and chemotherapy (capecitabine, Gemcitabine Paclitaxel, Nab-paclitaxel) chosen by physicians in 557 patients with unresectable or metastatic HER2-low breast cancer who had previously undergone 1-2 chemotherapy sessions. The trial also demonstarted that the Enhertu treatment group of HR+ cohort had a significant improvement in median progression-free survival (mPFS), with 10.1 months compared to 5.4 months in the control group. Enhertu also reduced the mortality risk by 50% in all patient cohort, including HR+ and HR- patients, compared to the control group. Furthermore, Enhertu demonstrated an anti-tumor response for the second-line treatment of HER2-mutant metastatic NSCLC through the DESTINY-Lung02 study. This study evaluated the efficacy and safety in patients with advanced, unresectable, or metastatic NSCLC who have previously been treated with systemic therapy, including platinum-based chemotherapy, more than once. The clinical results demonstrated that Enhertu had Blinded Independent Central Review (BICR)-assessed confirmed ORR of 49%, complete response (CR) of 1%, and partial response (PR) of 48%. "Enhertu’s expanded indication will provide an opportunity for patients with HER2-mutant lung cancer who had limited treatments options. It also provides HER2-targeting treatment options for over 60% of all breast cancer patients. Enhertu will be a meaningful treatment option for many patients from now," Daiichi Sankyo Korea’s Oncology Business Franchise Head Lee Hyun-ju said. "We are pleased to provide the new treatment option, Enhertu, to patients with HER-2 low metastatic breast cancer and HER2-mutant metastatic NSCLC. We will continue our efforts to improve cancer treatment settings based on our various oncology portfolio," AstraZeneca Korea’s Oncology Business Unit Director Yang Mi-sun said.
- Company
- 'China approves new drugs after completing trials in China'
- by Lee, Tak-Sun May 23, 2024 05:48am
- The Korea-China Bio Innovation Forum is being held in Hangzhou, China, from the 20th to the 22nd, with 25 Korean bio venture companies participating and meeting with more than 50 Chinese biotech and pharmaceutical companies China's drug approval authorities grant first-in-class drug approvals to drugs as soon as their multi-regional clinical trials (MRCTs) in China are complete, regardless of whether they are approved by the U.S. Food and Drug Administration (FDA) or other national drug regulatory agencies. Tigermed’s Senior Consultant Jessica Liu responded so to a domestic pharmaceutical company's observation that Korea's Ministry of Food and Drug Safety (MFDS) tends to approve new drugs after referencing the situation of advanced countries, such as whether the U.S. FDA or European EMA approves them. At the Korea-China Bio Innovation Forum hosted by Tigermed and Dream CIS in Xiaoshan, Hangzhou, China, on March 21, Senior Consultant Jessica Liu introduced China's drug approval regulatory policy. According to Liu, China's regulatory authorities have begun working to optimize the new drug IND approval system in 2027. The plan was to shorten the review period for the clinical trial plan from preclinical trials and optimize the review period for new drug approval applications, dividing the required period into 70 days, 130 days, and 200 days according to the approval track for each drug. In particular, China has been operating priority review, breakthrough review, and conditional approval systems for new drugs for which available treatments have been identified that meet the 'unmet medical needs' by targeting serious or life-threatening rare diseases. Korean pharmacuetical and biotech companies attending the forum asked for more details on the Chinese regulatory environment after the presentation. In Korea, first-in-class new drug approvals are granted after the authorities examine the drug’s situation in advanced countries such as the US FDA, and the question of whether the same applies in China attracted the attention of the participants. There were also questions about whether China has an orphan drug designation system like Korea and the United States. Domestic companies want to know if they can take advantage of an incentivized track in the licensing process when introducing treatment for a disease with a very small number of patients into the Chinese market. Jessica Liu, Senior Consultant, Tigermed Liu replied that China approves new drugs based on clinical data regardless of their US FDA approval status. While China does not have an orphan drug designation system, it does have criteria for rare disease drugs and an accelerated approval policy. Liu explained, "In China, a new drug application can be submitted and approved as soon as a large-scale multiregional clinical trial is completed in China without the need for FDA or other country’s drug regulatory authorization. In 2017, the regulations were updated to allow imported drugs to conduct Phase I MRCTs, removing the requirement that drugs need registered overseas trials or enter Phase II or Phase III trials.” Liu added, "Although China does not have an orphan drug designation track like in the US, it has published a list of rare diseases in 2018 and 2023, which currently has 207 rare diseases. Although there is no specific patient count threshold like the orphan drug system, rare disease treatments are subject to accelerated approval in China as well.” Meanwhile, the Korea-China Bio Innovation Forum is part of DreamScience's licensed-out new business program, Dream Science, which invites Korean biotech companies and ventures that want to enter China to China for partnership and networking meetings with Chinese pharmaceutical and biotech companies. From the 20th to the 22nd, 25 domestic bio venture companies will participate in the forum and meet with more than 50 local biotech and pharmaceutical companies in China, and will return with information and business information necessary for their expansion into China.
