“德丰杰龙脉”历时五年的维权道路近日终于迎来了最后胜果，北京市海淀区人民法院就曲敬东、北京新龙脉控股有限公司、北京新龙脉共赢资产管理有限公司、北京新龙脉联合资本管理有限公司、北京新龙脉卓越投资管理中心（有限合伙）、北京新龙脉壹号投资基金管理中心（有限合伙）的商标侵权行为以及不正当竞争行为予以登报公告，公开向“德丰杰龙脉”致歉并消除影响。

“德丰杰龙脉”历时五年的维权道路近日终于迎来了最后胜果，北京市海淀区人民法院就曲敬东、北京新龙脉控股有限公司、北京新龙脉共赢资产管理有限公司、北京新龙脉联合资本管理有限公司、北京新龙脉卓越投资管理中心（有限合伙）、北京新龙脉壹号投资基金管理中心（有限合伙）的商标侵权行为以及不正当竞争行为予以登报公告，公开向“德丰杰龙脉”致歉并消除影响。

  通过此次漫长的维权经历，“德丰杰龙脉”更加坚信正义必得伸张，混淆也必会澄清。“德丰杰龙脉”会采取一切必要措施继续打击侵权和不正当竞争行为，净化投资环境，努力保护投资人和合作伙伴的合法权益。

附：《人民法院报》公告及相关链接。

https://rmfygg.court.gov.cn/web/rmfyportal/noticedetail?paramStr=1100804825208565

德丰杰龙脉（上海）股权投资管理有限公司

2021年10月14日

作者：宁蒲

目前，中国医疗器械市场规模已迈入5000亿时代，医用内窥镜作为其重要子市场，也正迎来高增长时期。其中，国元证券等机构认为目前行业国产品牌渗透率较低，进口替代空间大，在分级诊疗、鼓励国产替代等政策以及产品高性价比优势下，行业成长性可观。

海泰新光是我国荧光腹腔镜领先企业，已逐步实现从技术跟随到技术引领，主要产品远销美国、欧洲和新加坡等国家和地区，与美国史赛克等国外多家知名医疗器械生产商合作紧密，内窥镜出口份额排名国内第一，部分产品已经可实现国产替代。

此次IPO募投项目完成后，海泰新光将显著提升内窥镜产能和技术能力，以满足市场的蓬勃需求。值得投资者注意是，国内相近行业的开立医疗市盈率在160倍左右，而此次IPO，海泰新光发行市盈率为45.54倍，后续是否会迎来更多估值溢价，值得市场期待。

医用内窥镜市场迎良好发展机遇

现代医学离不开各类医疗器械的辅助，内窥镜便是其一，现已成为普外科、耳鼻喉科、泌尿外科、骨科、妇科等科室不可或缺的诊断和手术设备。全球内窥镜市场规模也逐年增长，根据Evaluate MedTech数据，预计2019年全球内窥镜市场销售规模将达到209亿美元，并以6.3%的年均复合增长率增长至2024的283亿美元。

在行业内耕耘18年之久，海泰新光坚持医用成像器械领域的自主研发与创新，在行业内建立起了产品竞争优势。据了解，公司医用内窥镜已取得多项国际认证，主要产品远销美国、欧洲和新加坡等医疗器械制造实力较强的国家和地区。

其中，内窥镜为海泰新光贡献了主要营收来源，2019年，海泰新光以922.95万美元的销售额占全国内窥镜总出口金额的比例11.34%，排名第一。

持续创新服务顶级客户

筑牢长期发展护城河

自成立以来，海泰新光先以OEM为主，后转向ODM模式，不断加大研发力度，以适应小尺寸、高精度复杂系统的制造。2015年，海泰新光成功开发了应用于肝胆手术的高清荧光腹腔镜、荧光光源模组和荧光摄像适配镜头，成为精准微创外科发展趋势的先进技术应用，并合作国际知名内窥镜品牌，于2016年开始在北美市场销售产品。

此外，公司在聚焦光学和微创医疗器械领域的技术储备进一步多样化，在CMOS图像信号采集和高速传输、深度降噪和荧光增强以及基于ISP的图像处理平台技术上取得了突破；内窥镜摄像系统、超高清荧光内窥镜及内窥镜光源等项目逐步取得成果。至今，海泰新光围绕“光学技术、精密机械技术、电子技术及数字图像技术”四大技术平台形成了多项核心技术。

从行业来看，内窥镜图像已经经过了标清、高清（1080P）的发展期，正在向超高清（4K）分辨率发展。而海泰新光推出的第一款腹腔镜就实现了高清（1080P）分辨率，在市场上取得了良好的业绩，也成功开发4K超高清腹腔镜和4K超高清摄像系统，并已进入注册程序，为下一步市场拓展做好了产品准备。

进口替代空间巨大

募资加码研发提升产能

实际上，医用内窥镜集中了光学、人体工程学、精密机械、现代电子、计算机软件各项技术于一体，具有较高技术壁垒，而我国市场长期被国外企业占据，《中国制造2025》便明确提出要推动国产高端内窥镜医疗器械领域快速发展。而随着超高清视频逐渐落地、国内企业不断进行吸收创新、医患对国产品牌认可度的提高，国内医用内窥镜的进口替代时代有望来临。而海泰新光逐步实现了从技术跟随到技术引领的角色转换，产品如白光内窥镜已经可替代部分进口品牌。此外，海泰新光正积极向临床医学中内窥镜整机系统解决方案领域拓展，助力医疗器械的国产化替代进程。

根据弗利沙利文分析报告，2017年我国医用内窥镜行业销售额已达199亿元，预计2022年将达到320亿元。而近年随着市场快速拓展，海泰新光的产能已达到瓶颈，招股说明书显示，报告期内，公司腹腔镜产能利用率分别为99.67%、82.80%、95.05%和97.69%。

而此次IPO募投项目完成后，预计青岛生产基地年产内窥镜整机系统700台（套），另外将使公司新增4K超高清腹腔内窥镜、4K超高清适配器、关节镜、宫腔镜等产品，并继续进行超高清产品、微创医疗器械的研发和量产，为公司开辟新的增长驱动力，为成为医用成像器械领域世界领先的高科技公司进一步奠定实力。

德丰杰龙脉当选为中国投资协会创业投资专业委员会（简称中国创投专委会）副会长单位。

中国创投委是经国家发展和改革委员会批准成立、国家民政部批准登记的全国社会团体，是目前国内唯一经政府主管部门正式审批注册的全国性创业投资行业协会组织，旨在构建股权和创投企业与政府主管部门之间、股权和创投企业之间以及股权和创投企业与被投企业之间联系交流合作的桥梁与纽带，推动中国股权和创业投资行业持续健康快速发展。

投中榜单链接：https://www.chinaventure.com.cn/rank/list.html

Dr Dan Zhang, CEO of Fountain Medical Development (FMD), details the transformation China’s recent membership at the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) will bring to the drug development and clinical research landscape in China, the pressures and opportunities local companies will face, the unique position of FMD as the partner of choice for international companies conducting clinical research in China and his ambitions for FMD to become the first global CRO headquartered in China.

One of the most significant highlights amidst China’s healthcare reforms is China joining ICH in 2016 and subsequently becoming an executive member of the board last year. What impact will this have on the Chinese pharmaceutical landscape?

China became a member of ICH last year and this year, it became a major member of the executive regulatory committee at ICH. This has had a tremendous impact on the current research and development activities in China as well as on the globalization of China’s pharmaceutical R&D sector. Now that China is a part of ICH, the Chinese biotech sector will be exposed to uniform global regulatory and technical development standards. Both clinical and pre-clinical data are mutually recognized among all the members of ICH, which allows us to speed up innovative product penetration in the Chinese market.

At the same time, this also means fiercer global competition in the domestic market as all innovative products can now enter the Chinese market. A remarkable example is Merck’s new HPV vaccine, which was given a conditional green light by the then-CFDA (now NMPA) just nine days into its review, compared to the ten years it took for the previous version and for GSK’s own HPV vaccine! Naturally, the true beneficiary of this change are Chinese patients. In the past, they might have needed to travel to receive innovative treatments – if they can afford it – but now, the whole society can enjoy high-quality innovation as a more affordable price.

The consequence, however, is that Chinese innovative players, now subject to global competition, now have to consider how to survive and compete in their own country. The positive thing is, yes, in the short turn, it will bring more challenges to domestic firms but in the long run, it will strengthen the industry and allow R&D-focused Chinese companies to grow. It will also lead to local companies taking a step forward and starting global operations in order to survive, regardless of their readiness towards international expansion.

My prediction is that in only another few years’ time, the Chinese market and regulations will be significantly different from today’s picture. We all have to adapt. It is also why only R&D companies with international operations will be able to survive as they will have global capabilities to support them.

The environment is clearly getting more competitive. What challenges or opportunities does this change bring to a company like Fountain Medical Development, which is a Chinese CRO focused on helping innovative companies conduct clinical research to international standards?

Fountain Medical Development is a local Clinical Research Organization (CRO) founded in 2006. By that time, many global CROs were already in China such as Covance and Quintiles. I knew these global CROs well as I had previously been with Quintiles myself. At that time, I asked myself, why does China need another CRO?

In order to succeed, we found a market niche that had been overlooked by both foreign and local companies. Global CROs often worked mainly, if not exclusively with MNCs, because their prices were not affordable for local companies. On the other hand, domestic CROs were only serving local companies for domestic trials that focused mostly on generic products, as they lacked the capabilities to conduct global multi-centre trials.

Therefore, I created FMD to answer the needs of innovative, single compound companies entering the clinical stage. They are mainly local and international start-ups that are not fully established yet so most of their financing comes from the government or grants. Normally, they would be looking to start phase I clinical trials. FMD, therefore, positioned itself as the strategic partner for such companies specifically.

At that time in China, there were not as many such companies as there are now, so we mainly focused on government R&D and innovation programs in the first few years. We also obtained government financial support to start its activities while attracting other private investors as well. This allowed us to advance to the next level with our limited resources.

Our second unique advantage is the globalization of the company. From the beginning, our goal was to work internationally. This was partly driven by necessity as at the time, China was a smaller market with less homegrown innovations. Therefore, we soon opened offices in Hong Kong, South Korea and Taiwan. Subsequently, we acquired small companies in both the US and the UK.

Today, thanks to our dual strategy of organic growth and acquisitions, we now have more than 1,700 employees in 20 locations worldwide after 11 years in the industry.

What is the next stage of growth for the company now?

Our fundamental value proposition is that we serve our clients with innovative, high-level capabilities at affordable pricing. This was how we started and it remains the core of our business today. We understand the budget constraints small innovative companies are facing when doing clinical research. We have an international presence as well as comprehensive knowledge of the Chinese market. Therefore, we believe that we are in a very unique position to help Chinese companies go global – and to help global companies enter China.

We are now approaching our market through the prism of ICH. Firstly, we want to help more local companies expand internationally as it will be a decisive step for their success.

However, we are now focusing on a new niche. The whole world is looking at China now. We want to bring more global companies into China, especially from the USA. I am speaking about the same kind of single-compound, innovative biotech companies that we had previously served, but this time focusing more on the US or even Europe. Previously these companies would see China as too large or difficult a market for them to enter directly, so they would out-license their products to the MNCs or to local Chinese companies. However, with China standardizing their clinical research systems and processes now through ICH, they now have this new opportunity to conduct trials in China themselves without necessarily having to establish their own Chinese affiliate.

This is where FMD can help them. We know the China market extremely well and we are familiar with international standards. We are able to offer the services and solutions to help these companies enter the Chinese market.

We see that many global and even successful local Chinese companies like Wuxi AppTech have a very diversified offering. In the new environment, what do you see as a successful business model for Chinese CROs?

This is indeed the case, and Wuxi AppTech has a great business model. Clinical research is, however, the main focus of most CROs. As the largest outsourced segment in the world, we can see that out of the top ten global CROs, eight are focused on the clinical stage.

At FMD, we want to use our resources to the best of our capabilities and our team is specialized in clinical research. We know what we do very well. I want to maintain this clear focus. In any case, the market is big enough for different players.

I see that we also have much-untapped potential in the newest therapies being discovered like gene therapies and immunotherapies. What is striking is that many, if not most of them, have not yet been tested in Asian populations, so there is a huge need for clinical trials to be conducted in these markets. In particular, as China is now the second-largest pharma market, this need will only grow. Considering future growth, China might become the largest market in the next five to ten years. Multinationals need to do clinical trials here.

In this space, FMD is also the best partner for these companies as we have a proven track record of success working with both multinationals and smaller companies. Around 60 to 70 percent of our clients now is with multinationals. Over the last 11 years, our approval rate for New Drug Application (NDA) in China has been excellent; amongst the over 150 applications, we have received approvals except in one instance.

It is old thinking to assume that you should automatically go with the global CROs. Now China is open. In this new arena, it would not be wise to automatically dismiss China as not a global player. For instance, this year, the Chinese government invited 48 products deemed to be “clinically urgently needed new drugs” to apply for NDA without any clinical trials data required! Some were from MNCs but some are from smaller, orphan drug companies like Biomarin as well as biotech companies like Spark Therapeutics. China is opening its arms to the global pharmaceutical industry – so why should companies say no?

Do you have a final message for our international audience?

There is huge potential in China because we have such valuable resources. Firstly, we have to use China’s membership at ICH to welcome more innovation in the country. China was isolated before ICH but now it’s a new game. We want all of our clients to know that it is the right time to come to China and that we can help them be successful. FMD is welcoming all companies and we know China better than any other global company.

Secondly, we should take advantage of China’s vast patient population. If you think about it, China is over 20 percent of the world’s population. We have more patients in China that in the USA, so it can be an even better place to conduct research than the US. Patients are a unique resource that cannot be replicated so China should use that advantage.

Finally, our ambition now is for FMD to become a global CRO that is headquartered in China!