San Nuo Medicine-B (2257.HK): RNAi therapy has obvious advantages and great potential for growth.

格隆滙 · Dec 31, 2021 11:50

近年来，RNA赛道爆款产品频出。在细分的mRNA技术领域里，辉瑞（PFE.US）、莫德纳（MRNA.US）的mRNA新冠疫苗可谓是大放异彩，销售额不断刷新市场认知。与此同时，RNA赛道里另一项技术RNAi，在医药界也十分火热。

笔者注意到，昨日刚刚上市的$圣诺医药-B(02257.HK)$，正是一家专注于RNA赛道的领先企业。公司本次IPO最终定价65.9港元，首日挂牌上市大升近18%，而次日亦再升逾14%，表现令人眼前一亮。这家引入昆明佳时清、健新原力制药这两家公司作为基石投资者的RNAi疗法第一股，究竟应如何看它的价值？

神奇现象1+1=0？实现基因沉默的RNAi发展迅猛

在基因学上有一个神奇的现象居然能实现“1+1=0”。这个原理实际上是RNAi（RNA interference，RNA干扰），其本质是一种进化上高度保守的基因沉默现象。在内源基因作为“1”的基础上，引入外源性RNA作为另外一个“1”，就能够形成最终的结果“0”，即有效抑制内源基因的表达，使致病基因“沉默”。

理论上来说，RNAi优于任何以抑制蛋白功能为机制的传统药物。这也意味着该疗法覆盖面十分宽广，拥有极大的临床应用潜力。

从RNA干扰的发展历程来看，这个新兴疗法的机理于1998年正式被科学家认识后，RNAi行业却是经历了一波三折，初期的临床研究达不到理想的效果。但是经过多年的技术探索后，RNAi疗法已经度过最艰难的时期，目前正处于市场爆发的前夜。

自2018年来，随着RNAi的产品陆续获批上市，该疗法的商业前景在业内被大为看好。在美国首款获批的RNAi药物Onpattro（通用名为patisiran）由阿尔尼拉姆制药（ALNY.US）开发成功，用于治疗成人遗传性转甲状腺素蛋白（hATTR）淀粉样变性引起的周围神经病变。该款药物上市后的第二年，销售额迅速攀升13倍达1.66亿美元。更有知名的国际市场调研机构EvaluatePharma大胆预测，这款药物2024年的销售额将达到13.08亿美元。

基于RNAi技术的迅猛发展势头，市场对其充满乐观的预期。灼识咨询认为，RNAi疗法的全球市场规模将迅速扩大。未来的几年时间，其规模将以52.85%的年复合增长率从2020年的3.62亿美元增至2030年的251.95亿美元。而圣诺医药作为迅速增长的RNA赛道重磅玩家，未来将有较大的发展机会。

丰富管线构筑成长价值，自主研发尽显创新实力

圣诺医药不仅仅享受行业的增量红利，而且公司自身就拥有强大的实力。公司研发伊始看中的就是全球化的权益，布局存在巨大医疗需求及潜在市场的产品适应症。公司尤其重视中国和美国的市场，并因地制宜地采取相应的临床开发策略。

首先从公司的产品管线来看，圣诺医药在RNA的细分领域RNAi以及mRNA均有布局。公司拥有十多种候选产品，其核心产品STP705覆盖了不同治疗领域内的多个适应症。值得一提的是，凭借核心产品的顺利进展，圣诺医药还是首家RNAi在肿瘤学领域取得积极IIa期临床结果的公司。

STP705这款药物在肿瘤领域适用于鳞状细胞原位癌(isSCC)、皮肤基底细胞癌(BCC)这些美国最常见的癌种，以及在中、美患者生存率均较低的肝癌（HCC）。而且，公司还拓展了该药物在纤维增生性疾病方面的适应症，如瘢痕疙瘩无疤愈合和治疗增生性瘢痕(HTS)等目前没有完整治疗手段、存在较大临床缺口的疾病。不仅如此，STP705甚至在医美领域也具有一定的潜力，公司在美国开展其用于脂肪塑性的研究已经处于IND准备阶段。

公司的另一款产品STP707的适应症同样也是跨度宽广，目前正开发其适用于多发性实体瘤、非小细胞肺癌（NSCLC）、纤维化疾病等多种疾病的治疗。此外，公司的mRNA疫苗及疗法由附属公司RNAimmune负责开发，其中基于mRNA的SARS-CoV-2疫苗计划正与美国FDA进行IND前讨论。

由此可见，公司的STP705、STP707等产品适用范围广阔，横跨肿瘤学、纤维化等多个治疗领域。未来公司计划陆续开发出这些药物的更多适应症，更深入地挖掘其潜在的临床价值，从而具备了较大的发展前景。

再从公司的研发实力来看，圣诺医药在中、美两国建立研发中心，已经成功打造了数个专有的递送平台，包括RNAi领域内特有的多肽纳米导入系统（PNP）和新型的GalNAc RNAi递送平台，以及mRNA领域内自主开发的PLNP等递送平台。

这些平台是进一步开发RNA疗法的基石，而且需要多年的实践和研究积累，具有较高的行业门槛。而公司已拥有这些平台的核心专利，在目前及后续的RNA疗法研究中实现独立自主的药物研发。

其中，圣诺医药专有的PNP递送平台能够解决LNP及传统GalNAc RNAi递送平台的瓶颈。这个PNP递送平台还有可能将扩大RNAi技术的应用范围，充分发挥RNAi技术的更多价值。公司也将其用于STP705、STP707等候选产品的开发当中，提高药物的递送效率。

圣诺医药凭借全球化的长远视野，始终坚持自主研发，形成了丰富且全面的产品管线。公司的产品适应症多、覆盖面广，这些不同的适应症开发也在中美两地同步进行。一旦核心产品成功上市，其后续的适应症也有望加速推进审批，从而释放公司的成长性价值。

小结

身处快速发展的RNA赛道，圣诺医药无疑是一个实力强劲的玩家，拥有自主开发的递送平台、丰富的产品管线、广阔的适应症等多重优势，未来的想象空间巨大。公司目前的市值78亿港元（折合约10亿美元），对比232.71亿美元市值的全球RNAi龙头阿尔尼拉姆制药（ALNY.US），72.81亿美元市值的箭头制药（ARWR.US），29.45亿美元市值的Dicerna制药（DRNA.US）等美股上市公司来看，公司仍有较大的增长空间。圣诺医药未来表现将会如何，值得投资者期待。

In recent years, RNA track popular style products frequently. In the subdivided field of mRNA technology, Pfizer Inc (PFE.US), MRNA.US (MRNA.US) mRNA COVID-19 vaccine can be described as brilliant, sales continue to refresh market awareness. At the same time, RNAi, another technology in the RNA track, is also very popular in the medical industry.

The author noticed that it was just listed yesterday.$San Nuo Pharmaceuticals-B (02257.HK) $It is a leading company specializing in the RNA circuit. The company's IPO was finally priced at HK $65.9, rising nearly 18% on the first day of listing and more than 14% the next day. How on earth should the first share of RNAi Therapy, which introduced Kunming Jiashi Qing and Jianxin Force Pharmaceuticals as cornerstone investors, look at its value?

Miraculous phenomenon 1: 1: 0? RNAi, which realizes gene silencing, is developing rapidly.

There is a miraculous phenomenon in genetics that can actually achieve "1: 1, 1: 0". This principle is actually RNAi (RNA interference,RNA interference), which is essentially an evolutionarily highly conservative phenomenon of gene silencing. On the basis of endogenous genes as "1" and introducing exogenous RNA as another "1", the final result "0" can be formed, that is, the expression of endogenous genes can be effectively inhibited and the pathogenic genes can be silenced.

Theoretically, RNAi is superior to any traditional drug that inhibits the function of proteins. This also means that the coverage of the therapy is very wide and has great potential for clinical application.

From the perspective of the development of RNA interference, the mechanism of this new therapy was officially recognized by scientists in 1998, but the RNAi industry has experienced twists and turns, and the initial clinical research can not achieve the desired results. But after years of technological exploration,RNAi therapy has been through the most difficult period and is now on the eve of the market explosion.

Since 2018, with the approval of RNAi products on the market, the commercial prospect of the treatment has been greatly promising in the industry. Onpattro (commonly known as patisiran), the first approved RNAi drug in the United States, was successfully developed by ALNY.US to treat peripheral neuropathy caused by adult hereditary transthyroxine protein (hATTR) amyloidosis.In the second year after the drug went on sale, sales rose 13-fold to $166 million.What's more, a well-known international market research organization EvaluatePharma boldly predicts.Sales of the drug will reach $1.308 billion in 2024.

Based on the rapid development of RNAi technology, the market is full of optimistic expectations. Cautionary Consulting believes that the global market for RNAi therapy will expand rapidly. Over the next few years, its size will grow from $362 million in 2020 to $25.195 billion in 2030 at a compound annual growth rate of 52.85%.And San Nuo Pharmaceuticals, as a rapidly growing RNA track heavyweight players, will have greater opportunities for development in the future.

Enrich pipelines to build growth value, independent research and development to show the strength of innovation

San Nuo Pharmaceuticals not only enjoys the incremental dividends of the industry, but also has a strong strength of its own.At the beginning of R & D, the company set its sights on the global rights and interests, and there is a huge medical demand and product indications in the potential market.The company pays special attention to the market in China and the United States, and adopts the corresponding clinical development strategy according to local conditions.

First of all, from the perspective of the company's product pipeline, San Nuo Pharmaceuticals has a layout in both RNAi and mRNA, which is a subdivision of RNA.. The company has more than ten candidate products, and its core product, STP705, covers a number of indications in different treatment areas. It is worth pointing out,With the smooth progress of its core products, San Nuo Pharmaceuticals is also the first company for RNAi to achieve positive IIa clinical results in the field of oncology.

In the field of oncology, STP705 is suitable for squamous cell carcinoma in situ (isSCC), cutaneous basal cell carcinoma (BCC), which is the most common cancer in the United States, and liver cancer (HCC), which has a low survival rate in both Chinese and American patients. In addition, the company has also expanded the drug's indications for fibroproliferative diseases, such as keloid scarless healing and the treatment of hypertrophic scar (HTS), which do not have a complete treatment and have a large clinical gap. Not only that, STP705 even has some potential in the field of medicine and beauty, and the company is in the preparatory stage of IND to carry out its research on fat plasticity in the United States.

Another product of the company, STP707, also has a wide range of indications and is currently being developed for the treatment of multiple solid tumors, non-small cell lung cancer (NSCLC), fibrotic diseases and other diseases. In addition, the company's mRNA vaccine and therapy is developed by subsidiary RNAimmune, in which the mRNA-based SARS-CoV-2 vaccine program is in pre-IND discussions with FDA in the United States.

Thus it can be seen that the company's STP705, STP707 and other products are applicable to a wide range of oncology, fibrosis and other treatment fields.Future Corp.planMore indications of these drugs have been developed one after another, and their potential clinical value has been excavated more deeply, which has a great development prospect.

From the perspective of the company's R & D strength, San Nuo Pharmaceuticals has established R & D centers in China and the United States, and has successfully built several proprietary delivery platforms.Including the unique peptide nano delivery system (PNP) in the field of RNAi, the new delivery platform of GalNAc RNAi, and the delivery platform such as PLNP developed independently in the field of mRNA.

These platforms are the cornerstone of further development of RNA therapy, and require years of practice and research accumulation, with a high industry threshold. AndThe company already owns the core patents of these platforms to achieve independent drug research and development in current and subsequent RNA therapy research.

Among them, the proprietary PNP delivery platform of San Nuo Pharmaceuticals can solve the bottleneck of LNP and traditional GalNAc RNAi delivery platform. This PNP delivery platform may also expand the application scope of RNAi technology and give full play to the more value of RNAi technology. The company also uses it in the development of candidate products such as STP705 and STP707 to improve the efficiency of drug delivery.

With the long-term vision of globalization, San Nuo Pharmaceuticals has always adhered to independent research and development, forming a rich and comprehensive product pipeline.The company's products have many indications and a wide range of coverage, and the development of these different indications is also carried out simultaneously in China and the United States. Once the core product is successfully put on the market, its follow-up indications are alsoIt is expected to accelerate the examination and approval.To release the growth value of the company

Summary

In the fast-growing RNA track, San Nuo Pharmaceuticals is undoubtedly a strong player, with self-developed delivery platform, rich product pipelines, broad indications and other advantages, the future imagination is huge. The company's current market capitalization is 7.8 billion Hong Kong dollars (US $1 billion). Compared with US stock listed companies such as global RNAi leader ALNY.US (US $23.271 billion), US $7.281 billion Arrowhead Pharmaceuticals (ARWR.US) and US $2.945 billion Dicerna Pharmaceuticals (DRNA.US), the company still has plenty of room for growth. How San Nuo Pharmaceuticals will perform in the future is worthy of investors' expectation.

The translation is provided by third-party software.

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圣诺医药-B（2257.HK）：RNAi疗法优势明显，成长潜力巨大