Empagliflozin

Mumbai: In an exclusive interaction with ETPharma Editor Vikas Dandekar , Aman Mehta , Managing Director (Designate), Torrent Pharma from August 1 — outlines his clear roadmap. The aggressive buyouts in India to break into the top three ranks, a methodical ramp-up in the US market, expanding beyond oral solids into complex generics and injectables through partnerships, and the hurdles to a biosimilars ramp-up. Mehta also discusses the industry’s readiness for innovation, opportunities in GLP-1 weight-loss drugs, and why CDMO remains off Torrent’s radar. As the new MD, starting from Aug 1, it will be interesting to know your initial thoughts of leading the organisation at a time when there are both challenges and opportunities? It is an absolute honour and privilege to be taking up this new role. Most of the foundation has been laid by my father and uncle for the past two decades, when their vision was to build one of the leading India-based businesses in pharmaceuticals. I think it is mainly for me to follow that path to build on what they have laid as a platform and how do we incrementally invest further from here. We have seen ourselves as a more of a branded generics company for the last decade or more. Branded generics in the sense we operate in markets which are predominantly out-of-pocket, so India, Brazil being the two main markets. Of course, we have a strong presence in Germany as a third key market and then the US. So, it is more about evolving the existing platform with incremental steps and building a larger presence in the international markets from here on. India has a very strong base and how do we capitalise on the existing international presence to make it even stronger, that is the goal for the next couple of years. That would mean a more globalised organisation than you are at present. But the US market has not been as strong as it has been for most other top tier companies from India. Though there has been some uptick now from your last quarter's information. How do you want to go there? Do you think opportunities are there at present? What changes do you see and how will the Torrent strategy be going forward? Definitely we are not happy with our position in the US market as of today. It may have been the right call when we had taken to not double down on the US when the others had done so because we were facing different sets of challenges. But I think that time is now behind us and we would certainly need to enhance our presence in the US market. All said and done, it is the biggest market in the world as a generics player and we will need to find our niche in the US. And though it's late, I still believe that there are opportunities that exist. And there are ways we can leverage our existing strengths to have a meaningful uplift from here. In terms of the opportunities that you spoke of, can you take us through a few of those, what you think can be a good target for you in the US? Generally we see a swamping of generics. So how will it be different? Yes, absolutely. The space that we operate in, which is oral solids mainly, is quite crowded. And to differentiate, is becoming more and more difficult. But even then, there are opportunistic plays that keep coming every now and then. And those are the kinds of places which we would like to pursue rather than having an entry in a very crowded market, it's not the ideal way to grow from where we are today. Within oral solids, we still see that there are opportunities that exist. And outside oral solids there are multiple other avenues of growth - injectables, different platforms that we don't have currently, and we wish to partner in these models, where we work with companies who have existing infrastructure and who have complex products and they would seek a partnership model. That's the immediate goal for the next one or two years, and in non-oral products we would want to expand our portfolio through partnerships. There is also talk about acquisitions and there are a few targets in the US that some industry experts have been speaking about. Would you be keen to see those as part of your future mandates? Yes, definitely. There has been a slight change in our approach in the recent past. We were prioritizing mainly India for acquisitions. We do see that while organic growth must be the long-term growth driver, inorganic growth can improve our position from where we are today, if it is done in a thoughtful and disciplined way. So, while in the India market we are a bit more ambitious in terms of acquisitions, in the international markets we would be very measured and there would be a string of pearls approach rather than anything major or transformative. But certainly we are looking at acquisitions abroad, especially in the US, if something meaningful comes up, we would be quite keen to pursue it. Would that also include opportunities in biosimilars? Any niche play that you may want to get into? Biosimilars, overall, at this moment, no. I think to have a meaningful presence in biosimilars, you must invest a significant amount and it has a very long gestation period. So, as of now that's not on radar, but we are certainly studying the space and let's see if there's change anytime soon. But as of now that is not part of the plan. Is Europe a little more conducive so far as biosimilars are concerned? Yes, Europe is certainly conducive, in the sense that there are many more opportunities in terms of markets that have opened. We have a front-end presence in Germany, which is a key European market. We would be keen to explore licensing in biosimilars and leverage our front-end as the main opportunity for entering the biosimilars at this stage. India has been your backbone for growth. That’s a huge example, as we spoke about growing a business. Yet, in terms of rankings, if I see the last pharma-track data, you are at number seven. There are more aggressive companies, which are taking the market share higher. How do you want to describe your position in the home market? We are aware of those very speculative days of big bids, which couldn't really go through? What would be your plans going forward so far as the India market is concerned? As far as the India market is concerned, we have reached the position today through mainly inorganic growth over the last decade. Our rank was much lower ten years ago than it is today. That's certainly a big positive that has happened in the sense that from where we were to where we are, we are in a much stronger position to invest further and even grow the business from here. I would say that from here onwards, acquisitions will continue to remain a priority. And the top three in the Indian market is something that we have our eyes on. Organically it may be difficult to achieve in the near term. But certainly through inorganic growth it seems quite possible, and may be in the next couple of years, if something materializes, that certainly is going to be part of our ambition. So you will aggressively pursue an inorganic buyout route to see that your ranking improves and probably get into the top three? That's correct, absolutely. That is again, something that has been a very bold and very unconventional move from Torrent side. We had always associated Torrent within a particular range of buyout, but if it is really a breakout kind of a buyout that will be a very strong move and a commitment to the Indian market, is it? Yes, absolutely. The commitment to the Indian market remains as strong as ever. Even with some of the structural changes that are happening or have happened in the recent years, we believe that the inherent demand of the Indian pharma market is not going to change. And that is what gives us confidence to invest inorganically as well. The base of the market will not shift dramatically, and that's where we want to be - a top 3 player from currently, we are 7th. Top 3 looks to be an ambitious but realistic goal. Within how much time do you think that probably could happen? I would say, hopefully in the next 3-5 years. Generally what we see of the Indian market, of course there are dramatic changes happening, but most of it is very crowded. We saw in the empagliflozin market, 150-170 players within a couple of weeks? Is there a kind of a tiredness because how much can you sell for the same? The pricing really crashes and it doesn’t really make you any different from being the 93rd player which is also selling the same empagliflozin? We were actually studying the same very recently to understand what new launches may be, how have they evolved over the last five years versus today. You are right in the sense that certainly a very large number of entrants who are in the market on day one. Having said that, interestingly what we also analysed is that 90 per cent of the market remains with the top 6-7 companies. So, you are essentially losing only 10% of the market when new competition walks in. So, it is certainly not positive that there is so much competition, but it is also not so dramatically negative either. And we see that in fact our performance as far as Torrent Pharma goes in the new launches, has been one of the strongest we have seen in recent years. In terms of market share, whether empagliflozin or sitagliptin from two-three years ago, we have been consistently in the top two to three market share ranks when new launches are concerned. So, I would say that while the number of launches looks very very competitive, market share gives a very different picture and it's essentially within top six to seven companies for most products. That's a very interesting data. So, in how much time does that situation change? Say for example, if 150 new launches happen within a few weeks and then in your reading 90 percent share is with a few players, in how much time do you think this situation changes? Within the first few months it is very visible. If the market share trends of the first 2-3 months are seen, they don't change dramatically. Unless there is a product differentiation or price disruptions that happens. But in those cases it is very very rare to change the market share after the first couple of months of launch. And that's evident already in the empagliflozin case that was mentioned. You have expanded your base of medical reps significantly in the last 3 years from 3600 to 6400. So, it's a very strong statement again to really go deep down in the market. What's been the strategy there and do you think you will be adding more to that number? Yes, certainly. We closed this year at 6400 MRs. If I look back at 2021, maybe four years ago we were at 3600. So, we may close this year at nearly 7000 this year. So that's almost doubling in four years. So, it's a progressive move that we are making into more - methodical expansion, to have more products in the market with adequate market share and also increase the territorial reach, where may be were not adequately present before. We have seen that the last couple of years, especially in the last two years have given pretty good results in doing so. Maybe we were a bit late in doing it. But nonetheless, it is still an opportunity that's quite meaningful and we will continue to pursue field force expansion going ahead as well. As we have discussed the top three markets, US, Europe and India. Now is the time to shift the gears a little bit more on how do you see the competitive landscape going so far as India is concerned vis-a-vis what we are seeing from China. There are dime-a-dozen deals that are happening from China, in terms of early stage to mid-stage to even some late-stage compounds being licensed out. The last one was 3S Bio giving Pfizer $ 6bn deal. How do you see that in comparison to what our Top Indian companies are doing or are positioned? China has certainly leapfrogged on the innovation front over the last decade. I think there is so much innovation coming from the Chinese companies, whether to US or Western markets or within China. Maybe they don't really have much of an incentive to be in the generics space. I think they have kind of already transitioned to the innovation space. So in generics in oral solids we still don't see much competition from China coming in. In certain segments such as injectables, there is definitely tough competition coming from Chinese companies. But what we are seeing is that most of the Chinese companies and Chinese investments are going to innovation and it's quite incredible how the number of deals, out licensing have skyrocketed in the last couple of years. There is a question about how Indian companies see that big change happening. There have been hurdles and there have been drips. How do we leapfrog? Is there something to be done to really gain that momentum? Yes, I think as far as Indian companies are concerned, many companies have invested and certainly there has been an ambition and effort put in in the last several years. And there is still a lot of investment. In terms of innovation in India, several companies have invested in this. There are companies who are still investing in this. But to really get on a global scale, it would require many things to come together including support from various institutes, from government, from multiple ecosystem approaches that need to play rather than individual companies coming in. It's not too far out but it's certainly today it's tough to match that level of investment required. The ambition of the industry is certainly to move up the value chain. There are talks that we have seen are very encouraging from various forums of making a move to this. Maybe in the next 5-10 years, things will change. So, at least the companies are in a very strong position today in the Indian pharma market to invest seriously and meaningfully for innovation. And it's certainly looking possible that India could also make the leapfrog change in the coming decade. We have seen that it is a strenuous journey to move into an innovation fold and the results are again spectacular, if you really stayed the course of the entire journey, we have seen how companies have been able to really gain a lot of traction and also beef up their pipeline. Hopefully that will also happen with some of the other Indian companies. I was again interested in something that is being talked about almost everywhere about GLP-1 and weight-loss drugs. Any thoughts on that for Torrent, how do you want to position? Will you be among the first wave of launchers in India when the semaglutide patent expires in 2026 March? Yes, certainly. It has been on our radar for quite some time. And we have positioned our launches as of now hopefully to be in the first wave. We are looking at both - injectable GLP1 and Oral GLP-1. We believe as of now, the injectable market will likely be more crowded. But we will still aim for a meaningful play in this space, given our existing strengths in the chronic diseases segment. But oral, as of now, is going to be a smaller part of the market, but may be less competitive as of now. And we are positioned as of today, to be in the first wave of the launches. So, while both will be important and meaningful launches for Torrent, the oral could be a bit more interesting in the sense that there could be less competition playing out here. Will there be any opportunities to do a launch for tirzepatide also? But I think the patent expiry is only in 2036. So, do you think there will be some opportunities there as well? No, not until the patent expires, unless there is a partnership route. So, Lilly generally has been interested in partnering with Indian companies. So, hopefully if something works out there, that would certainly be of interest. I also believe there are some other siRNA products which are being worked out, some completely different modalities and Indian companies have been tying up with global MNCs to launch those kind of products. So those opportunities are also something that you can look forward to, right? Yes, absolutely. Those are more as of now going to be through licensing. Because patent expiration is a bit far away. Some of them have already been launched in the Indian market. But the main thing is the accessibility and pricing. These are very very expensive products. So, if there is a way to bring down the price meaningfully, through either innovation or obviously after patent expiration it will be different, but licensing may be a cost effective therapy in this space that would really be beneficial for the Indian market. Because right now it is miniscule share of patients who get access to it. There is a PCSK inhibitor from Novartis – inclisiran - which is already here in the Indian market, and then there is again a protein-based therapy from Amgen, which is being sold by Dr Reddy's - Repatha. So those kind of products are something that probably will be lapped up by Indian companies, so far as the reach is concerned? Absolutely. Even then the pricing would be a constraint, to match the Innovator pricing. Indian companies would launch but still - naturally in a patent period that's not very unusual. While that's a big positive, whether this market can really increase in size, it's all a matter of bringing down the pricing. Hopefully in the next couple of years, some innovations would help bring that. What's your sense on CDMOs? Many companies are looking at that opportunity and there is a lot of growth. Some of the reports that we see, say that a market of about 140-150 billion, where India has a very miniscule presence, may be less than 10%. Do you think that could also be an opportunity for you going forward? Overall Indian CDMOs have done fantastically well over the last couple of years. It's probably something that may continue to get more shares globally from other markets or other countries. So, overall Indian CDMOs, to me, seem very very positioned for very good growth from here. As far as we are concerned, we have not considered entering this space. It's a fundamentally different business model compared to what we operate in. And I am not sure that it is something we would be able to justify if we are entering this space. As of now we have no plans to enter CDMO space. If I am to sum up the conversation we had, you will look at stage-wise ramp up, selective ramp up in the US, domestic market. You will not hesitate to do big buyouts, with the aim of being in the top 3 or 5 leading Indian companies. CDMO is not really an interesting opportunity for you, Europe probably could be a good area for biosimilars, in terms of launching, because you already have a beachhead in Germany. And I think, overall, the picture you gave looks like a good setup for an opportunity to grow. Right? That's the way you would like to summarize it? Absolutely. The most one-line summary is that we are just not happy with our international presence today. We certainly have a big job ahead of us and we are keen that we build a much bigger presence. And we would look at capital allocation in the international markets very differently to what we had in the past. Which will be routed for acquisitions as well? Yes. Acquisitions will be part of it but again, it will be very very methodical, and nothing transformational. It will be in a very digestible way I would say. Any views on MFN, pricing, tariffs all the things that we are getting signals from the West? I think we are on the same page as everyone. And in the same boat as everyone else, that is still very uncertain. Of course, if it does get implemented, it could be a slight negative for the industry overall. But again, generics may not be impacted to the degree that branded Pharma would be. That's the current feeling. I think it's best to wait for the fine print to come out before taking any actions or making any speculative comments at this moment. Don’t miss the full conversation. Watch the complete interview here: By Vikas Dandekar ,

编者按作为新型非甾体类盐皮质激素受体拮抗剂（nsMRA），非奈利酮在糖尿病合并慢性肾脏病（CKD）领域的应用价值持续引发学界关注。今年美国糖尿病协会科学年会（ADA 2025）公布的CONFIDENCE研究亚组分析、肾脏标志物研究及FINE-ONE研究的基线特征3项研究，从不同维度进一步丰富了非奈利酮的研究数据，拓展了对该药物心肾保护作用及机制的认知，为糖尿病肾脏疾病（DKD）患者的临床决策提供了更精细化的证据支持。本刊特邀北京医院潘琦教授对这3项研究进行深入解读。CONFIDENCE研究亚组：对于基线不同血糖水平的T2D合并CKD患者，联合治疗均可显著降低UACR本月初正式发布的CONFIDENCE研究首次回答了心肾保护药物非奈利酮和钠-葡萄糖协调转运蛋白2抑制剂（SGLT2i）联合应用的疗效和安全性问题，为心肾获益药物的应用策略提供了里程碑式证据。该研究证实，对于T2D合并CKD患者，相较任一单药治疗，非奈利酮与恩格列净同步起始联合使用更能显著降低白蛋白尿水平，相关结果已发表于《新英格兰医学杂志》[1]。CONFIDENCE研究的血糖亚组分析[2]刚刚在ADA年会公布，旨在评估基线糖化血红蛋白（HbA1c）水平是否影响联合治疗效果。研究设计与背景CONFIDENCE研究中，CKD定义为估算肾小球滤过率（eGFR）30~90 ml/min/1.73 m2、尿白蛋白肌酐比值（UACR）≥100~<5000 mg/g、HbA1c<11%。受试者按1:1:1随机分配至非奈利酮（10 mg/d或20 mg/d）+安慰剂、恩格列净（10 mg/d）+安慰剂、非奈利酮（10 mg/d或20 mg/d）+恩格列净（10 mg/d）治疗组。本次亚组分析按基线HbA1c水平对患者进行四分位数分组，分析HbA1c较基线的变化，同时评估第180天UACR较基线的相对变化，旨在评估基线血糖水平对联合治疗疗效的影响。关键结果数据基线特征2022年6月~2024年8月，共有来自14个国家/地区818例患者被随机分组，其中800例纳入全分析集。基线平均eGFR 54.2 ml/min/1.73m2，中位UACR 579 mg/g，781例受试者的平均HbA1c为7.3%。按基线HbA1c水平对患者进行四分位数分组（Q1，≤6.4%；Q2，>6.4% ~ ≤7.1%；Q3，>7.1% ~ ≤7.9%；Q4，>7.9%），各组人数分别为212例、190例、188例和191例。HbA1c四分位数组间的基线特征基本均衡，部分指标存在差异，其中包括平均HbA1c、中位UACR、糖尿病视网膜病变患病率及胰岛素使用率（表1）。表1. 按HbA1c四分位数划分的基线人口统计学和临床特征HbA1c变化第180天时，各治疗组之间HbA1c较基线的变化无显著差异，恩格列净组HbA1c较非奈利酮组有下降趋势（图1）。同样地，在每个四分位数组内，各治疗组第180天时HbA1c较基线的变化虽然无统计学差异，但恩格列净组HbA1c较非奈利酮组有更低的趋势，且随基线血糖升高趋势更明显（图2）。图1. 第180天时，各治疗组之间HbA1c较基线的变化无显著差异图2. 每个四分位数组内，各治疗组第180天时HbA1c较基线的变化也无差异UACR变化联合治疗在所有HbA1c四分位数组中降低UACR的幅度均显著大于单药治疗（图3）。Q1组联合治疗较非奈利酮单药和恩格列净单药分别多降低29%（95%CI：-48% ~ -4%）和38%（95%CI：-54% ~ -15%）（图4）；Q3组联合治疗较单药分别多降低36%（95%CI：-54% ~ -10%）和34%（95%CI：-52% ~ -10%）。这种差异在各血糖分层中具有一致性，提示联合治疗的肾脏保护作用不依赖于血糖控制效果（图4）。图3. 第180天时HbA1c较基线的最小二乘均数变化图4. 根据HbA1c四分位数分组，联合治疗相较于任一单药治疗从基线至第180天的UACR百分比变化该亚组分析证实，非奈利酮与恩格列净联合治疗在不同基线HbA1c水平的T2D合并CKD患者中，均可显著降低UACR，且效果优于单药治疗，为T2D合并CKD患者的心肾保护提供了联合用药的进一步证据。无论基线血糖如何，联合治疗均可比单药治疗提供更多的心肾脏保护获益。肾脏标志物研究：非奈利酮在优化治疗基础上的额外肾脏保护效应研究设计与方法该研究[3]回顾性分析了60例T2D合并CKD（1~3期）患者，所有患者均接受SGLT2i（达格列净）、血管紧张素受体拮抗剂（ARB，缬沙坦或替米沙坦）治疗，血压控制在<130/80 mmHg至少1年，在此基础上加用非奈利酮并随访6个月。定期监测体重、体重指数（BMI）、血压、血脂、高敏C反应蛋白（hs-CRP）、N末端脑钠肽前体（NT-ProBNP）、eGFR（分别基于肌酐和胱抑素C）、血钾及UACR等指标，旨在评估非奈利酮在接受ARB和SGLT2i治疗的DKD（1~3 期）患者中对肾脏标志物的影响。主要研究结果基线数据患者平均年龄60.05±10.21岁，80%患者eGFR>60 ml/min/1.73m2，86.66%患者UACR在30~300 mg/g，平均HbA1c 7.16%±0.169%，基于肌酐的eGFR（eGFRCr） 88.96 ± 33.15 ml/min/1.73m2，基于胱抑素C的eGFR（eGFRCy） 65.2 ± 22.115 ml/min/1.73m2，血钾4.576 ± 0.45 mEq/L，UACR 170.76 ± 241.84 μg/mg，hs-CRP 1.35 ± 1.13 mg/L，NT-ProBNP 106.87 ± 100.68 pg/ml。基线平均用药剂量缬沙坦112±39.2 mg，替米沙坦87.43±43.37 mg，非奈利酮12.67±4.43 mg。ARB使用者占66.66%，血管紧张素受体脑啡肽酶抑制剂（ARNI）使用者占33.33%，钙通道阻滞剂（CCB）使用者占33.33%，β受体阻滞剂使用者占30%。治疗后变化6个月时，UACR较基线显著降低59.35%（自基线降至101.348±33.93 μg/mg，P<0.001），体重平均下降0.8 kg（P=0.025）。而血压（收缩压降低1.33±1.671 mmHg，P=1；舒张压降低1.9±1.34 mmHg，P=0.486）、HbA1c（变化0.038%±0.105%，P=1）、eGFRCr（降低0.713±2.22 ml/min/1.73m²，P=1）、eGFRCy（降低6.0±3.26 ml/min/1.73m2，P=0.063）、血钾（降低0.007±0.048 mEq/L，P=0.1）及NT-ProBNP（升高11.018±5.69 pg/ml，P=0.174）等指标的变化均无统计学意义。非奈利酮剂量在随访期间增至16.70±4.92 mg，ARB剂量略有调整，但整体用药方案保持稳定。研究结果显示，在已接受SGLT2i和ARB优化治疗且血压控制达标的T2D合并早期CKD患者中，加用非奈利酮可进一步显著降低UACR，对血糖、血压、eGFR、血钾指标无明显影响。这一结果提示，非奈利酮的肾脏保护作用可能独立于传统降压、降糖及SGLT2i的机制，为临床中已接受标准治疗但仍存在蛋白尿的患者提供了肾脏保护的新选择。值得注意的是，UACR是T2D合并CKD心肾获益的强预测因子，该研究中，在ARB和SGLT2i治疗基础上，UACR降幅仍达59.35%，凸显了非奈利酮在蛋白尿管理和心肾保护中的独特价值。FINE-ONE研究基线特征：非奈利酮在1型糖尿病合并CKD患者中的探索1型糖尿病（T1D）患者中约1/3合并CKD，超过半数会出现肾功能显著丧失，近1/4进展至肾衰竭，而目前针对T1D合并CKD的特异性治疗手段有限。FINE-ONE研究旨在评估非奈利酮在T1D合并CKD患者中的疗效与安全性[4]。研究设计与基线数据FINE-ONE是一项正在进行的全球Ⅲ期非奈利酮临床研究。研究纳入242例T1D合并CKD患者，要求UACR≥200~<5000 mg/g，eGFR≥25~<90 ml/min/1.73m2，HbA1c<10%，血清钾≤4.8 mmol/L，且正在稳定服用ACEI/ARB。患者按1:1随机分至非奈利酮组（10 mg或20 mg，每日一次）或安慰剂治疗组。主要疗效指标是6个月时UACR相对于基线的变化（治疗结束后停药随访1个月）。值得注意的是，药监部门批准研究采用UACR作为主要终点，认可UACR作为桥接标志物可将FIDELITY研究T2D合并CKD人群的证据转换（“translate”）到FINE-ONE人群。在研究纳入的242例患者中，大多数为男性（65%），平均年龄51.6岁；最常见地域来自欧洲（50%），其次为北美（34%）和亚洲（16%）；86%患者有高血压病史，基线平均血压135.2/77.5 mmHg，超过99%患者使用ACEI/ARB，36%患者使用利尿剂，27%使用β受体阻滞剂；大约1/4患者有心血管疾病史，74%使用他汀；基线平均糖尿病病程32年（表2）。研究排除了在T1D中推荐证据有限的SGLT2i和GLP-1RA使用者。平均eGFR 58.8±19.1 ml/min/1.73m2，48%患者eGFR≥60 ml/min/1.73m2伴蛋白尿；中位UACR 549（299~1191）mg/g，74%患者UACR≥300 mg/g；平均HbA1c 7.6%±1.1%；平均血钾4.6±0.4 mmol/L（图5）。表2. FINE-ONE基线人口统计学和临床特征图5. FINE-ONE基线实验室数据FINE-ONE研究是首个评估非奈利酮用于T1D合并CKD患者的Ⅲ期研究，其基线数据显示入组患者具有较高的肾脏事件风险和心血管共病率。该研究结果将填补非奈利酮在T1D领域的证据空白，若能证实其肾脏保护作用，将为这一缺乏有效治疗手段的患者群体提供新的治疗选择。目前研究仍在进行中，其最终结果值得期待。专家点评非奈利酮重塑糖尿病肾脏疾病管理格局潘琦教授 北京医院非奈利酮作为新一代nsMRA，ADA今年新公布的3项研究从多维度探索，进一步证实了其在DKD领域的循证价值。不同血糖水平患者联合治疗的全新证据CONFIDENCE亚组分析证实，非奈利酮与恩格列净联合治疗在平均HbA1c 6.4%~>7.9%的T2D合并CKD患者中，降低UACR效果均优于单药治疗（如HbA1c>7.9%组联合治疗较单药治疗多降34%~36%）。这一发现证明了在不同血糖水平的T2D合并CKD患者中联合治疗的普适性，不同血糖水平患者均可从非奈利酮与SGLT2i联合治疗方案中获得额外心肾保护收益。优化治疗基础上的增量保护真实世界研究显示，T2D合并早期（1~3期）CKD患者，在ARB+SGLT2i治疗基础上，加用非奈利酮仍可使UACR进一步降低59.35%，且安全性良好，对血糖、血压、eGFR和血钾均无显著影响。该结果揭示了其与现有疗法的机制互补性，为早期DKD患者提供蛋白尿和心肾风险管理新手段，其UACR降幅远超传统方案预期，提示非奈利酮在疾病早期的干预价值。T1D领域的开拓性探索FINE-ONE研究作为首个针对T1D合并CKD的Ⅲ期临床研究，入组患者呈现高肾病事件风险（中位UACR 549 mg/g）和高心血管共病特征。若证实疗效，将打破该人群治疗手段有限的困境，成为首个代表nsMRA的T1D心肾保护药物。从独特机制到心肾保护ADA发布的新研究数据进一步印证非奈利酮独立于血糖、血压、靶向肾脏纤维化的核心优势。作为国内外指南推荐的心肾保护重要支柱治疗药物之一，非奈利酮不断积累新证据，推动早期多机制心肾保护药物治疗，促进糖尿病合并CKD领域的管理迭代，使更多患者尽早获益。专家简介潘琦 教授北京医院内分泌科主任医学博士，主任医师，教授，博士研究生导师中华医学会骨质疏松与骨矿盐分会委员中华医学会糖尿病学分会糖尿病监测与治疗技术学组副组长中国老年保健研究会老年骨质疏松分会秘书长中华医学会老年医学分会内分泌学组副组长北京医学会糖尿病分会副主任委员“四大慢病”国家科技重大专项首席项目负责人主持国家省部级课题9项，参与多项国家重大攻关课题、国家自然科学基金等项目国内外核心期刊发表论文160余篇《Diabetes Care中文版》《中华医学杂志》《中华内科杂志》《中华老年医学杂志》《中华全科医学杂志》《中国医学前沿》《中国糖尿病杂志》《中国心血管病杂志》编委参考文献（上下滑动可查看）1. Agarwal R, et al. Finerenone with Empagliflozin in Chronic Kidney Disease and Type 2 Diabetes. N Engl J Med. 2025 Jun 5. doi: 10.1056/NEJMoa2410659.2. Rajiv Agarwal, et al. Simultaneous Initiation of Finerenone and Empagliflozin Across the Glycemic Spectrum in the CONFIDENCE Trial.2025 ADA.3. Vishal Gupta, et al. Evaluating the Effect of Finerenone on Renal Markers in Patients with Diabetic Nephropathy (Stage 1–3) Receiving Angiotensin Receptor Blockers and SGLT2i Therapy. 2025 ADA.4. Hiddo L. Heerspink, et al. Baseline Characteristics for FINE-ONE — A Randomized Phase III Trial Assessing Finerenone in People with T1D and CKD. 2025 ADA.声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《国际糖尿病》编辑部）版权声明版权属《国际糖尿病》所有。欢迎个人转发分享。其他任何媒体、网站未经授权，禁止转载。