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- 2026-08-08 04:39:58
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- "Streamlining researchers' tedious tasks"...Pluto Labs envisions AI expansion
- by Hwang, byoung woo Aug 06, 2026 05:25pm
- While a researcher's competitiveness is in formulating new hypotheses, a significant portion of research time is spent searching for published research articles, categorizing prior studies, and verifying experimental methods. Pluto Labs, an artificial intelligence (AI)-driven academic technology startup, aims to address this repetitive workload. The company aims to extend beyond searching articles to supporting research topic identification, hypothesis formulation, and experimental validation, thereby expanding researchers' execution capacity. DailyPharm met with Junseon Yoo (38), CEO of Pluto Labs, to discuss the story behind the company's founding, the key differentiators of its research-support AI, and its strategy for expanding into the pharmaceutical and biotech sectors.The startup began with frustrations over research article searchJunseon Yoo, CEO of Pluto LabsPluto Labs originated from the personal frustration CEO Yoo experienced while directly engaging in academic research.Having majored in Industrial Engineering at POSTECH, Yoo participated in authoring research papers in mechanical engineering before expanding his research focus into AI and computer science. Throughout this process, Yoo realized that searching for relevant papers and data consumed as much time as conducting the actual experiments. Yoo began developing the service as a project in 2017 and incorporated the company in 2019. CEO Yoo remarked, "When conducting research, I experienced much greater frustration while trying to find existing information created by others than in formulating hypotheses and running experiments. Pluto Labs is the company founded specifically to solve that problem.”Pluto Labs' core technology relies on analyzing citations and categorizing research areas.Papers within the same discipline repeatedly utilize similar keywords. Simple keyword searches often retrieve papers with entirely different methodologies or research questions. Pluto Labs overcomes this by analyzing how papers cite one another, clustering them according to specific research topics and methodological approaches. Pluto Labs' leading service, Scinapse, analyzes field-specific research trends so that users can search for literature and researchers. Scinapse AI is currently expanding into supporting the process from initial literature reviews to generating and evaluating research hypotheses. Currently, its primary paying customers are universities and research institutions. The platform is utilized in the early planning phase to help researchers identify viable research topics tailored to their existing technologies and equipment, or to check unaddressed research gaps in existing literature. CEO Yoo explained, "The service helps researchers identify which problems will yield the highest impact given their available technologies and equipment, and pinpoints remaining research gaps in a given field," and added, "It functions less like a simple paper search tool and more as a strategic roadmap generator for research direction."Research that can be performed immediately over "Nature-Level" hypothesesGlobal corporates are also entering the AI market for research hypotheses and planning. CEO Yoo cited DeepMind's Co-Scientist as an example attempting to solve problems similar to Pluto Labs. However, Pluto Labs focuses less on generating the highest-level hypotheses for top-tier publication and more on presenting options that most researchers can realistically execute within their current resources and timeframe. Yoo stated, "No matter how exceptional a proposed hypothesis or research plan may be, if it requires unavailable equipment or experiments that take two to three years, it is unusable for a researcher who needs to publish a paper this year," and added, "Pluto Labs focuses on identifying the best possible choices researchers can execute under their present constraints." The company considers securing a leading position advantage in the research institution market as a competitive strategy. Universities and research institutes rarely adopt duplicate software solutions for the same function and instead use established platforms for a long period. Yoo stated, "Institutions and universities are a conservative market that rarely replaces tools once adopted," and added, "Securing domestic paid contracts and overseas pilot projects early on creates a strong barrier to entry." Following the release of Scinapse AI in October 2025, Pluto Labs secured two paid contracts in South Korea within three months. The company is currently running over six pilot projects, including overseas trials. In South Korea, POSTECH officially adopted the service, while KAIST initiated a pilot implementation.Enterprise software targeting universities and research institutes typically involves long sales cycles aligned with institutional fiscal years and budget allocations. Yoo analyzed that securing paid contracts and pilot programs immediately post-launch was a significant milestone proving early market viability.Yoo said, "Institutional research tools operate in a market where sales cycles are estimated at a minimum of one year, yet we secured domestic paid contracts within three months of launch," and added, "Considering this product targets academic institutions, expansion is progressing at a remarkably fast pace."From pipeline analysis to experimental AI agentsPluto Labs is also actively expanding its university and research institute-centric services into the pharmaceutical and biotech industries.The company's AI agent currently under development analyzes information embedded in research literature, such as corporate affiliations, investigators, and funding sources, to map out competitive drug discovery landscapes. The goal is to identify companies researching specific targets or modalities and global pharma firms investing in related fields, thereby supporting business development (BD) strategy formulation. Currently, the company is validating market demand through AI-generated report offerings, with plans to later deliver this functionality as a standalone software tool for direct researcher use. Pluto Labs is also developing an agent designed to minimize trial and error in experimental execution. By analyzing existing literature and quantitative datasets, it evaluates hypothesis relevancy while identifying potential outliers or noise within experimental data. The focus of this AI agent is preventing scenarios where researchers belatedly discover flawed experimental conditions or missing variables, forcing redundant trials. The company aims to unveil this service officially this fall. Yoo noted, "Identifying a drug target does not automatically yield a therapeutic. One needs an experimental design to validate whether the target is truly viable, and the iterative trial cycles consume the most time," and added, "Ultimately, our goal is to build products that reduce repetitive experimental cycles and compress the overall R&D timeline."In the long run, the vision encompasses utilizing not only published literature but also unpublished internal datasets and negative and failed experimental logs accumulated within research institutions.Yoo observed that current Large Language Models (LLMs) face inherent limitations in comprehending numerical data and domain-specific contexts. Even identical quantitative values hold vastly different implications depending on the research field and experimental setup. Nuanced language-centric models struggle to differentiate this sufficiently.Yoo remarked, "A difference of 20 may be negligible in one discipline, but massive in another," and added, "Academic research centers around numbers and symbols, but current models struggle to guarantee sufficient intuition or reliability regarding numerical values."Yoo concluded by noting that "There are tasks that are important yet tedious, and tasks that are minor yet tedious," and added, "I want Pluto Labs to be remembered as a company that resolves these bottlenecks, expanding the scope of what researchers can transform from imagination into research works."
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- Yorvipath for chronic hypoparathyroidism, addressing limited trt options
- by Lee, Jeong-Hwan Aug 06, 2026 05:25pm
- Product photo of YorvipathThere is an urgent need to raise social and medical awareness of chronic hypoparathyroidism, a rare disease caused by parathyroid hormone (PTH) deficiency.The recent emergence of Yorvipath (palopegteriparatide), an innovative drug that directly replaces parathyroid hormone, is driving a paradigm shift in treatment for patients who previously relied solely on high-dose calcium supplements and active vitamin D due to the lack of disease-modifying therapies. The need to improve disease awareness is also being highlighted.Developed by Denmark-based Ascendis Pharma, Yorvipath obtained marketing approvals in Europe in 2023, the U.S. in 2024, and Japan in 2025, and subsequently obtained orphan drug designation in South Korea for the active ingredient palopegteriparatide this past March.Currently, Kolon Pharma, which entered into an exclusive domestic distribution agreement with Ascendis Pharma, submitted a marketing authorization application to the Ministry of Food and Drug Safety (MFDS) in May, and as of the 4th, Yorvipath is undergoing the MFDS approval review process.Chronic hypoparathyroidism is a rare condition that often suffers from a lack of awareness about the disease, leaving patient diagnosis and treatment in a blind spot. Chronic hypoparathyroidism is a rare endocrine disorder where deficient secretion or impaired function of parathyroid hormone (PTH) leads to severe hypocalcemia and hyperphosphatemia.Patients suffer from various physical and mental symptoms, including numbness and tingling in the extremities, muscle cramps, tetany, extreme fatigue, and cognitive impairment. However, low awareness of the disease among both the public and healthcare professionals often leads to initial symptoms being dismissed as simple fatigue, eye twitching, or nutritional imbalance, failing to lead to proper specialized diagnosis.Medical experts advise, "If left untreated, chronic hypoparathyroidism can progress to life-threatening severe hypocalcemic crises or chronic complications, making proactive outreach and heightened disease awareness a priority."Until now, the standard of care for chronic hypoparathyroidism has involved daily administration of active vitamin D and high-dose calcium supplements. However, these symptomatic treatments fail to replace the deficient PTH hormone itself and impose a heavy pill burden on severe patients, who must ingest dozens of calcium and active vitamin D tablets daily.A greater issue involves long-term complications. While administering excessive calcium and active vitamin D under PTH-deficient conditions may temporarily maintain serum calcium levels, it fails to restore PTH's role in regulating renal calcium reabsorption, potentially leading to hypercalciuria (excessive urinary calcium excretion). If persistent, this significantly elevates the risk of severe secondary renal damage, including nephrolithiasis, nephrocalcinosis, and chronic kidney disease (CKD).Disease-modifying drug Yorvipath, a paradigm shift via 24-hour physiological hormone replacementYorvipath, developed by global biopharmaceutical company Ascendis Pharma, has been evaluated as opening a new era in the treatment of chronic hypoparathyroidism.Yorvipath is a PTH replacement therapy engineered to continuously provide active PTH(1-34) within physiological ranges over 24 hours. Administered once daily via subcutaneous injection, it is designed to physiologically address the underlying PTH deficiency, the underlying cause of hypoparathyroidism, by maintaining continuous systemic exposure to active PTH.In the pivotal global Phase 3 PaTHway trial, a randomized, double-blind, placebo-controlled study in adult patients with chronic hypoparathyroidism, 79% (48/61) of patients in the Yorvipath arm met the primary composite endpoint at 26 weeks, maintaining albumin-adjusted serum calcium within normal ranges and maintaining a stable Yorvipath dose while achieving independence from conventional therapy. Furthermore, 93% (57/61) of Yorvipath-treated patients achieved independence from conventional calcium and active vitamin D therapy.Additionally, the Yorvipath group demonstrated improvements in estimated glomerular filtration rate (eGFR) from baseline and achieved normalization of mean 24-hour urinary calcium excretion levels (250 mg/day or lower). This suggests the potential to substantially reduce the risk of nephrocalcinosis and progression to chronic kidney disease, which remain major concerns under conventional care.Moreover, assessments using the Hypoparathyroidism Patient Experience Scale (HPES) demonstrated significant reductions in physical symptom burden alongside marked improvements in overall quality of life.To date, Chronic hypoparathyroidism has been a neglected disease where patients had to ingest large amounts of calcium supplements at the risk of renal complications due to the absence of hormone replacement therapy. As Yorvipath has demonstrated clinical efficacy and safety, calls to raise disease awareness and prioritize public health policy support are growing.Healthcare experts stress that to ensure patients with chronic hypoparathyroidism receive timely, accurate diagnoses and benefit from advanced hormone replacement therapies like Yorvipath, efforts must concurrently focus on ▲public and primary care disease awareness campaigns, ▲dissemination of accurate diagnostic guidelines, and ▲institutional support to enhance treatment access.A representative from Kolon Pharma stated, "Chronic hypoparathyroidism has represented a major unmet medical need where patients had no choice but to manage symptoms via calcium and active vitamin D supplementation due to the lack of hormone replacement therapy directly treating the root cause of PTH deficiency," and added, "We will do our utmost to secure marketing authorization and reimbursement for palopegteriparatide inj so that it can be supplied to patients as swiftly as possible."
- Company
- Homegrown drug powers SK Biopharm to 39% operating margin
- by Cha, Ji-Hyun Aug 06, 2026 05:25pm
- SK Biopharmaceuticals maintained an operating margin of approximately 39% in Q2, once again demonstrating the profitability of its homegrown innovative drug business. Despite lower one-off licensing revenue and increased marketing investment, the company continued to grow earnings on the strength of epilepsy drug sales alone, highlighting the improving quality of its earnings.According to the Financial Supervisory Service on Aug. 5, SK Biopharmaceuticals posted KRW 97.1 billion in consolidated operating profit for Q2, up 56.9% year over year. Revenue rose 40.3% year over year to KRW 247.4 billion. The operating margin remained stable at 39.2%, compared with 39.4% in the previous quarter.The company's epilepsy treatment cenobamate (marketed as Xcopri in the U.S.) drove earnings growth. Cenobamate is an innovative epilepsy drug independently developed and commercialized by SK Biopharmaceuticals, with the company taking charge of the entire process from discovery and clinical development to regulatory approval and commercialization. The company obtained U.S. Food and Drug Administration (FDA) approval in November 2019 and has marketed the drug directly in the United States through its subsidiary SK Life Science since May 2020.Q2 U.S. sales of cenobamate reached KRW 224.4 billion, up 45.6% from the same period last year. Cumulative U.S. sales for the first half totaled KRW 422.1 billion. Prescription growth also continued. Total prescriptions (TRx) in the United States increased 8.4% quarter over quarter to approximately 143,000 in the second quarter, while new-to-brand prescriptions (NBRx) remained above 1,800 per month on average. Monthly prescriptions reached a record 49,155 in June.Change in quarterly SK Biopharmaceuticals performance (Source: SK Biopharmaceuticals)The company said the latest results were particularly meaningful because earnings growth was achieved without one-off gains. Profit growth was sustained solely through the sales of Xcopri, even in a situation where the contribution of technology fee revenues decreased, and expenses increased.In Q1, one-off milestone payments related to overseas approvals of cenobamate contributed KRW 17.1 billion in service revenue. No comparable milestone revenue was recognized in Q2, resulting in a KRW 7.4 billion sequential decline in service revenue.Selling and administrative expenses also increased during the quarter. SG&A expenses rose 9.3% from the previous quarter to KRW 135.3 billion, reflecting expanded marketing activities, including the resumption of direct-to-consumer (DTC) advertising in April and the launch of a new DTC campaign in June.SK Biopharmaceuticals attributed its strong profitability to operating leverage. While fixed costs associated with establishing its U.S. commercial infrastructure and sales organization were substantial during the early launch period, rapidly increasing prescriptions have driven revenue growth while SG&A and other fixed costs have remained relatively stable. As a result, incremental revenue has translated directly into earnings growth, allowing profits to increase faster than sales.During the company's earnings conference call held the same day, Hyungrae Cho, Head of Communications at SK Biopharmaceuticals, said, "The fact that operating profit increased despite the absence of one-off milestone revenue and higher SG&A expenses once again demonstrates that expanding U.S. sales of cenobamate directly translate into earnings growth.”In addition to seeking sales growth of cenobamate, SK Biopharmaceuticals is also accelerating development of its pipeline.First, the company is seeking to expand the presence of cenobamate in the global market through label expansions across additional indications and age groups. A New Drug Application (NDA) for an oral suspension formulation of cenobamate was submitted to the FDA in March. The liquid formulation is expected to improve treatment convenience for patients who have difficulty swallowing tablets, including pediatric patients. The company anticipates its approval in early 2027.The company also plans to submit a supplemental NDA (sNDA) later this year to expand indications to include primary generalized tonic-clonic seizures (PGTC) and pediatric patients. In Asia, cenobamate has already been approved in Korea and launched in China. The regulatory process for its approval is ongoing in Japan, with approval targeted for within the year. In Latin America, launches have already taken place in Peru and Chile, with Brazil scheduled to follow this month.SK Biopharmaceuticals’ early-stage pipeline review (Source: SK Biopharmaceuticals)The company is also actively working to secure its next growth engine. Beyond cenobamate, SK Biopharmaceuticals is building its next-generation pipeline around three strategic areas: central nervous system (CNS) small molecules, radiopharmaceutical therapy (RPT), and targeted protein degradation (TPD).In RPT, the company is pursuing both in-licensed assets and internally discovered candidates. SKL35501 (FL-091), an Actinium-225-based NTSR1-targeted radiopharmaceutical, is currently in a Phase I clinical trial in the United States. Another candidate, SKL37321 (WT-7695), a Lutetium-177-based CA9-targeted radiopharmaceutical, is undergoing preclinical development with an Investigational New Drug (IND) application planned for 2027. The company is also developing its proprietary Noble Chelator platform, designed to overcome the stability and scalability limitations of existing chelators while enabling compatibility with a broader range of radioisotopes and targeting molecules. The platform is intended to support repeated generation of multiple RPT candidates rather than a single candidate.In TPD, SK Biopharmaceuticals is advancing SKT-18416, a selective p300 degrader. This TPD is designed to target the p300 protein involved in cancer cell growth and survival. Unlike conventional dual p300/CBP inhibitors, which have raised safety concerns such as thrombocytopenia because they inhibit both proteins simultaneously, SKT-18416 is designed to selectively degrade p300 while minimizing effects on CBP. An IND submission is targeted for the first half of 2027.The company has also established MOPED, a molecular glue discovery and analysis platform, to generate additional TPD pipeline candidates. In June, SK Biopharmaceuticals entered into an AI-driven drug discovery collaboration with Insilico Medicine, aiming to shorten early-stage candidate discovery timelines, reduce development costs, and improve the probability of success.Cho said, “Insilico Medicine signed AI-based drug discovery partnerships with global top-tier pharmaceutical companies for other disease areas in both March and July this year. By combining our in-house AI drug discovery platform with our collaboration with Insilico Medicine, we expect to significantly reduce both the time and cost required for early-stage candidate discovery."Cho added, “The company plans to provide updates on pipeline progress and R&D achievements over the first 9 months of the year during our Q3 earnings announcement in early November. We will continue reinforcing a virtuous cycle in which cash generated from cenobamate funds development costs and risks, with the resulting returns reinvested into future innovative drug development."
- Company
- Voranigo under review for reimbursement in Korea
- by Eo, Yun-Ho Aug 06, 2026 05:24pm
- Voranigo, the first new brain tumor therapy approved in nearly two decades, is making progress toward National Health Insurance reimbursement listing in Korea.According to industry sources, Voranigo (vorasidenib), Servier Korea's treatment for IDH-mutant diffuse glioma, is expected to be reviewed by the Cancer Disease Deliberation Committee (CDDC) of the Health Insurance Review and Assessment Service (HIRA) on Aug. 19.After being granted marketing authorization in January, Servier launched Voranigo as a non-reimbursed treatment in May and submitted its reimbursement application during the same month.As a result, attention is rising on whether the first IDH-targeted therapy for low-grade glioma will become available under the national reimbursement system.Voranigo is indicated for adolescents aged 12 years and older who weigh at least 40 kg, and for adults with grade 2 astrocytoma or oligodendroglioma harboring an IDH1 or IDH2 mutation.Low-grade glioma is a slowly growing brain tumor that carries a high risk of recurrence and can eventually progress to a high-grade malignant tumor. The disease is often first detected following seizures, and surgical resection has long been the standard treatment.However, complete tumor removal is frequently not feasible, while subsequent radiotherapy and chemotherapy are associated with substantial risks of cognitive impairment and neurological adverse effects, leaving significant unmet treatment needs.IDH mutations are recognized as a key biomarker in approximately 80% of patients with grade 2 glioma. Both the World Health Organization (WHO) and the National Comprehensive Cancer Network (NCCN) now recommend testing for IDH mutations as part of the diagnostic workup.The efficacy of Voranigo was demonstrated in the Phase III INDIGO trial, which enrolled patients with low-grade IDH-mutant glioma who had undergone surgery but had not yet received radiotherapy or chemotherapy.Study results showed that Voranigo reduced the risk of disease progression or death by 65% compared with placebo. Median progression-free survival (PFS) was 11.4 months in the placebo group, whereas the median was not reached in the Voranigo group. Voranigo also significantly delayed time to next intervention (TTNI). In addition, the annual seizure rate during treatment was reduced by 64% compared with placebo.Jong Hee Chang, Professor of Neurosurgery at Severance Hospital. said, "Voranigo is the first newly approved brain tumor therapy since temozolomide was approved for glioblastoma in 2006. The arrival of Voranigo represents a major advance, given that most drugs have failed development because they were unable to adequately cross the blood-brain barrier (BBB).”
- Company
- Is there a separate 'drug price premium' track for companies other than innovative firms?
- by Kim, Jin-Gu Aug 05, 2026 01:17pm
- Following the adjustment of the generic drug price calculation rate from 53.55% to 45%, the 'drug price calculation system' is emerging as a critical exit strategy for the pharmaceutical industry to defend profitability.The drug price bonus tracks under the revised drug pricing system are broadly divided into 'company-level premium' and 'product-level premiums.' While the pharmaceutical industry's focus was previously concentrated on company-level premiums, such as for Innovative Pharmaceutical Companies, the 'in-house API production' premium track granted to individual products is recently surfacing as a new mechanism for price defense. According to the pharmaceutical industry on the 4th, supplier-based company-level premiums determine the generic price caps for a given company across the board depending on whether specific eligibility criteria are met. Companies certified as Innovative Pharmaceutical Companies based on metrics such as R&D investment relative to revenue receive a premium rate of 60%, while semi-innovative pharmaceutical companies receive 50%. Additionally, pharmaceutical manufacturers maintaining a designated threshold of essential/low-profit drugs (anti-withdrawal drugs) are categorized as supply-stabilization leader companies, qualifying for a 50% price calculation rate premium. During discussions surrounding the reform of the drug pricing system, these company-level premiums drew significant attention from the pharmaceutical industry. Frontline drugmakers deployed exit strategies such as re-evaluating their R&D investment ratios and restructuring research and development expense line items on their financial statements.68% Price Cap + Up to 10 Years… Why the Pharma Industry Is Focusing on "In-House API Production"Recently, in addition to securing eligibility for company-level premiums, interest is mounting in "product-level premiums" tailored to the specific characteristics of individual drugs.Product-level premiums are granted based on individual product attributes, such as drugs utilizing ▲in-house manufactured APIs, ▲national essential drugs using domestic APIs, ▲injectable antibiotics and essential pediatric medications, and ▲designated pharmaceuticals to resolve supply instability. The underlying objective is to provide preferential pricing benefits for products that contribute to health security and pharmaceutical supply chain stability. Among these, the track attracting the most focus from the pharmaceutical industry is 'in-house API production.' The government has agreed to guarantee a drug price equivalent to 68% of the original price cap for a baseline period of 5 years if a generic is produced by directly synthesizing active pharmaceutical ingredients in the manufacturer's own facility. Furthermore, if eligibility conditions are continuously met, an additional 5-year extension is granted, allowing drugmakers to maintain elevated drug prices for up to 10 years or more (5 years + 5 years + α).AI-generated image.Under the previous drug pricing system, the premium duration was limited to just 1 year, yielding minimal practical benefits. However, under the new pricing framework, sentiment has shifted dramatically, as the premium period has been expanded to 10 years and the premium rate is applied at the highest level (68%). Because companies can secure a price 23 percentage points higher than the baseline calculation rate (45%) over an extended timeframe, certain products can yield even higher profitability than the Innovative Pharmaceutical Company premium rate (60%). Of course, for companies lacking internal API manufacturing infrastructure, the in-house API production premium track is not an easy path. It requires equipping in-house manufacturing plants with chemical synthesis facilities compliant with ICH Q11 standards, and it consumes substantial time, capital, and administrative resources for manufacturing process development and marketing authorization variations. The government also strictly enforces criteria for recognizing in-house API production, limiting eligibility strictly to "production within the marketing authorization holder's (drugmaker's) own manufacturing site," while excluding facilities owned by parent companies, subsidiaries, or affiliates.Nevertheless, analysts suggest that the ability to maintain a 68% price cap over an extended duration in an environment where the baseline generic pricing rate has dropped to 45% offsets these entry barriers.'10-Year Rule' and 'Cost Burden' Variables… Targeting Products with Patent Expirations in 2 to 3 YearsIndeed, drug pricing managers across numerous domestic pharmaceutical companies are reportedly engaging in meticulous return-on-investment calculations regarding entry into the in-house API production track.The single biggest variable is the 'timing of the first generic listing.' Under the regulations, the starting point for the 10-year premium period is calculated based on the 'listing date of the first generic in the market,' rather than the 'listing date of the company's own product.'For instance, for hypertension and hyperlipidemia active ingredients where generics were already listed en masse in the mid-2010s, the 10-year limit following the first generic listing has either already passed or is imminent. Even if a drugmaker invests billions of KRW immediately to establish an API synthesis process, there is little practical benefit, as the premium duration has already expired or has only a few months remaining.Conversely, the situation is different for molecules whose patents expired within the last two to three years or where the generic market has just opened. A prime example is the diabetes treatment market for DPP-4 inhibitors or SGLT-2 inhibitors, where major originator patents expired in or after 2023. Because the timing of the first generic listing in the market is recent, there remains a window of mathematically 7 to 10 years to receive the 68% drug price premium. This structure allows companies to recover facility investment costs and enhance profitability.Another variable is the "cost burden." Pharmaceutical companies must meticulously weigh the manufacturing cost of using lower-cost Chinese or Indian APIs against the operational and maintenance costs of running their own synthesis facilities versus the profit yielded by the 68% drug price premium.Under this current structure, rather than indiscriminately applying the in-house API production track to all products, drugmakers are evaluating a selective-and-focused strategy—targeting API synthesis investments specifically toward major products with recently expired patents. This represents a two-track strategy: defending overall generic pricing through company-level premiums like Innovative or Semi-Innovative status, while evaluating in-house API production premiums for core flagship products.An official from a major pharmaceutical company explained, "If company-level premiums serve as a track to defend the baseline drug prices across the entire company, in-house API production is a targeted strategy to maximize revenue for key products," and added, "The practical benefits of the in-house API production track will be substantially greater for pharmaceutical companies with a high revenue reliance on specific products."A drug pricing manager at another pharmaceutical company also noted, "For major chronic disease products whose patents have recently expired, we judge that defending a 68% drug price cap for several years is advantageous," and concluded, "We are currently evaluating whether to apply the in-house API production track centered around our key major products."
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