In 2025 years, the Hong Kong stock market has made a turnaround.
Since the beginning of the year, the Hang Seng Index has risen 3.0%, and the Hang Seng Tech Index has surged 0.0%. Innovative pharmaceutical companies, which have been undervalued for a long time, have also entered a structural bull market. From the launch of the Category C catalogue to the implementation of childcare subsidies, the integrated development of medical and health industries, medical technology innovation and application will receive more market attention and support.
The core reason why the market is bullish on innovative drugs is the tilt of policies.
今年2月，十部委參與、創新藥新扶持政策：從支付端的多元化，到市場端的葯價激勵，再到資本端的鼓勵險企總資產5%投資創新藥，彰顯了國家扶持創新葯的決心。3月6日扶持再度加碼，國家發展和改革委員會主任鄭柵潔宣佈，國家將組建國家創業投資引導基金，撬動地方資金和社會資本近1萬億元，直指硬科技領域，聚焦人工智慧、生物製造等前沿領域。
一直以來，中國創新藥都是政策鼓勵的方向。中國創新藥崛起，始於港股18A政策，隨著市場對創新葯資產認知度的提升，説明眾多有潛力的產品實現產業落地，説明更多明星產品進入中國市場，有利於填補臨床中存在的空白。
隨著港股市場全面轉暖，政策扶持力度持續加大，創新葯無疑將再次成為市場焦點，屬於它的春天已經到來。3月21日，專注於內分泌相關治療領域的維昇藥業成功登陸港股市場，成為國內2025年第一家上市的創新藥企。
Why was Weisheng Pharmaceutical able to take the lead in conquering the capital market and become the "first stock of innovative drugs" in 2025 years?
"Innovation" is often accompanied by failure and uncertainty, and in the disruptive innovation of innovative drugs, failure and uncertainty are necessary costs, but the market can see the scarce "certainty" from Weisheng Pharmaceutical.
儘管維昇藥業尚未有產品進入商業化階段，但它的核心產品長效生長激素——隆培促生長素（lonapegsomatropin，TransCon hGH），已經做好了爆發的準備。目前，隆培促生長素已完成中國3期臨床試驗，其上市許可申請（BLA）於2024年3月獲得中國國家葯監局（NMPA）受理，預期2025年內獲批。
In addition, this product has been approved for marketing in the United States in 2022 years and in the European Union in 0 years for the treatment of growth hormone deficiency in children (PGHD). After a number of market verifications, it is only a matter of time before Rompei somatotropin is fully released from commercialization.
兒童生長激素缺乏症（PGHD）是兒童矮小症最主要的病因之一，是因腺垂體無法產生足夠生長激素而引發的激素缺乏性疾病，通常表現為比例正常的身材矮小、無法達成理想中身高，代謝異常甚至會引起心理障礙、認知缺陷和生活品質下降等問題。據不完全統計，中國2022年18歲以下的矮身材人數就超過800萬例。
For patients with PGHD, growth hormone injections are the most effective and well-established treatment, which can help children achieve the goal of accelerating growth and increasing adult lifetime height. However, the traditional treatment method of daily growth hormone injections may seem simple, but if it is needed for several years, it can be a heavy burden for both the child and his or her parents. Just imagine, it is not easy for ordinary people to insist on getting up early every day, not to mention that children with PGHD need one injection a day, and the phenomenon of missing needles is very likely to occur, which will affect the final treatment effect. Therefore, long-acting growth hormone (LAGH) with low injection frequency has become the future industry iteration direction of growth hormone.
Looking at the global LAGH drug landscape, a total of 5 LAGH drugs have been successfully launched, and a number of LAGH drugs are in clinical progress. However, only one LAGH has been approved for marketing in the domestic market, and more LAGH products are still needed to jointly fill the huge treatment gap in clinical practice.
Figure: List of long-acting growth hormone (LAGH) research and development, source: Pharmaceutical Rubik's Cube
Note: 4) The approval time in the table is the time when each product is approved for the first time in the world; 0) Novo Nordisk somapacitan was first approved for growth hormone deficiency in children from 0 years 0 months (FDA);
From a technical point of view, the LAGH drugs developed by different companies choose to modify or protect the growth hormone molecule, so that it can be injected into the body to avoid rapid metabolism and elimination by the body, prolong the survival time of the drug in the body, so as to achieve long-term effects.
However, although the general direction of R&D is the same, a completely different path has been adopted in the specific technology implementation link.
Most long-acting growth hormone uses permanent modification technology, that is, permanent attachment of one other molecule to the growth hormone molecule to form a recombinant human growth hormone analogue with significantly increased molecular weight to achieve long-acting results. However, Lompei auxin uses a temporary ligation technology (TransCon), which forms an inactive prodrug by temporarily linking the growth hormone molecule to an inert carrier molecule. After prodrug injection, junctional structures can auto-dissociate at a specific rate, slowly releasing unmodified growth hormone molecules at a controlled rate.
Figure: Mechanism of action of Rompei somatotropin, source: Weisheng Pharmaceutical prospectus
Although the permanent modification technology can reduce the metabolism rate of growth hormone, it also changes the natural structure of the drug molecule, and changes its pharmacological properties and biological effects to a certain extent. For Rompei somatotropin, the innovative temporary connection technology can ensure that the active drug released in the body maintains the molecular mechanism of natural growth hormone, and achieves the tissue distribution and physiological utility that are completely consistent with the growth hormone secreted by the human body. It is based on such technical differences that Rompei somatotropin is very likely to become a BIC product.
In order to ensure the smooth commercialization of Rompei auxin-promoting hormone, Weisheng Pharmaceutical has made full preparations: in terms of the distribution of imported products, it has chosen to cooperate with Shanghai Pharmaceutical Holdings, the local production of products is responsible for WuXi Biologics, a leading CDMO in China, and has selected high- and mid-end private medical institutions with good reputation and credibility such as United Family for non-public channels. A series of commercialization preparations have been progressing steadily, and the precise layout of the commercialization strategy by the management team has gradually been revealed.
It is worth noting that this IPO introduced 5 cornerstone investors: Anke Biologics, Suzhou Industrial Park Industrial Investment Fund, Vivo Capital, WuXi Biologics, and Reynold Lemkins. Anke Biotech is a well-known growth hormone head enterprise in China, with mature growth hormone sales channels, and is expected to complement Weisheng Pharmaceutical.
Everything is ready, only the east wind is owed. The core products that are ready to go are the primary reason why capital values Weisheng Pharmaceutical.
Lompei somatotropin is only one part of the total value of Weisheng Pharmaceuticals. In addition to Rompei somatotropin, Weisheng Pharmaceutical also has two blockbuster products that are committed to filling the clinical gap - paroberiteriparatide and narvepetide.
Paropetriparatide is a hormone replacement therapy drug for adults with chronic hypoparathyroidism (HP), which maintains the physiological level of parathyroid hormone within 24 hours a day by subcutaneous injection once a day, reduces daily discomfort in patients, and reduces the probability of long-term complications.
For a long time, patients with HP have been suffering from low parathyroid hormone secretion but no therapeutic drugs that can target the cause, and are very prone to acute clinical manifestations such as hypocalcemia, hyperphosphatemia and the resulting increased neuromuscular excitability, as well as chronic complications that can affect the whole body. In the field of endocrine system diseases, HP was once considered to be the last endocrine hormone deficiency disease that has not yet achieved true hormone replacement therapy. At present, the only treatment for patients with HP includes supplementation with a large amount of calcium and/or active vitamin D, but this is only a symptom but not a cure, and cannot replace the role of parathyroid hormone, nor can it fundamentally solve the problems of high blood phosphate and abnormal bone metabolism.
作為全球首創HP激素替代療法，帕羅培特立帕肽極有可能為HP患者提供突破性的治療方案，有望促進甲旁減治療指南的調整。目前，帕羅培特立帕肽已經在歐洲、美國獲批上市，中國3期關鍵試驗已在2023年1月完成，達到主要複合終點，進入開放性擴展階段，有望成為維昇藥業未來的第二增長點。
Figure: List of progress of paropetriparatide, source: Jinqi Research Institute
Navepertide is a therapeutic drug for achondroplasia (ACH, the most common skeletal dysplasia) in children, which continuously inhibits the over-activated FGFR3 receptor pathway and restores the normal proliferation and differentiation of chondrocytes and the growth and development of bones throughout the body by taking it once a week.
ACH is an autosomal dominant disease, which is the most common skeletal dysplasia, mainly caused by mutations in fibroblast growth factor receptor 3 (FGFR0) gene, and has been included in the second batch of rare diseases in China. At present, there is no approved drug for the treatment of the underlying cause of ACH in China, and it can only be intervened through the use of growth hormone or surgery, but this is still a "last resort".
作為潛在的ACH對因藥物，那韋培肽在2024年4月完成中國2期臨床試驗，並順利達到主要終點。基於國家對罕見病治療藥物加速上市審批流程的利好政策，那韋培肽後續的上市進展有望加快，那麼那韋培肽將有可能成為填補國內ACH治療空白的突破性藥物。
在去年7月《全鏈條支持創新藥發展實施方案》正式審議通過後，“真創新”成為後續醫保談判的主基調。何為“真創新”？那就是必須滿足臨床“真需求”，只有從實際臨床出發去填補空白的產品，才是符合時代脈絡的“真創新”。
Whether it is the soon-to-be-commercialized somatotropin, or the rapidly progressing paropetriparatide and narveropathide, their starting point is to solve the actual needs of the vacant clinical practice, and they are indisputably "truly innovative" products.
If Rompei somatotropin represents the short-term expectation of Weisheng Pharmaceutical, then the other two drugs that have reached clinically important nodes determine the long-term value of Weisheng Pharmaceutical. Through three "truly innovative" products, the endocrine matrix built by Weisheng Pharmaceutical has taken shape.
Different from the fierce competition in the field of cancer, endocrine drugs are a blue ocean track. The field of endocrinology covers more than 170 diseases, covering all ages from newborns to the elderly, and almost everyone is his audience. More critically, at least nearly half of the diseases still lack effective treatments, and there is an extremely obvious unmet clinical need, and there is an urgent need for an industrial giant.
The strategic foothold of another path and forward-looking track planning are the second reasons why the market values Weisheng Pharmaceutical.
Why does Weisheng Pharmaceuticals dare to innovate hardcore? This is due to the company's technological cornerstone, Ascendis, one of its founding shareholders.
For Ascend, it has a comparative advantage because its core pipeline has been validated by Ascendis.
Ascendis公司總部坐落於丹麥，近日市值已突破一百億美金，是近年來美股炙手可熱的“超新星”。憑藉TransCon技術平台的領先優勢，Ascendis公司擁有持續研發FIC內分泌新藥的能力，而維昇藥業則擁有相關藥物的大中華區優先談判權。
Chart: Ascendis stock price action, source: Xueqiu
TransCon stands for "transient linkage", i.e., the connection of an unmodified prototype drug to a protective inert carrier molecule through a junctional structure with a controlled dissolution rate to form a prodrug. After the current drug enters the human body, the junction structure dissolves and releases the unmodified prototype drug, so as to effectively extend the half-life of the drug without changing the prototype drug.
In layman's terms, TransCon technology is like helping a prototype drug put on a pair of armor, and after breaking through the bullets of the body's immune system, the prototype drug can take off the armor according to the plan and use its own skills.
The value of the TransCon technology platform may be difficult for many investors to understand, but we can better understand it through MNC's actions. At the end of last year, Ascendis granted Novo Nordisk an exclusive worldwide license to the TransCon technology platform, which allows Novo Nordisk to develop, manufacture and commercialize proprietary Novo Nordisk products for metabolic diseases, including obesity and type 85 diabetes. Ascendis, on the other hand, received an upfront payment of up to US$00 million, as well as significant subsequent milestone payments.
強如諾和諾德這樣的MNC，都選擇TransCon技術平台進行合作，這足以表明Ascendis公司所擁有的底層技術力。Ascendis是維昇藥業的創始股東之一，維昇藥業2018年已從Ascendis獲得搭載TransCon技術的3款創新藥在大中華區研究、開發、製造及商業化的獨佔許可，維昇藥業既能夠享受到Ascendis的技術力，也能夠享受到產品商業化的利潤，而無須另行支付首付款、里程碑和利潤分成。
The technical support of shareholders is the hidden value implied under the surface R&D pipeline of Weisheng Pharmaceutical, which is also the third reason why Weisheng Pharmaceutical is valued.
Although it is very likely that Rompei auxin will become a big hit, this does not fully define the value of Weisheng Pharmaceutical. With regard to Weisheng Pharmaceutical, the investor landscape must be opened, and in order to thoroughly understand the value of this company, it must be based on a comprehensive understanding of its strategy.
In the short term, Rompei somatotropin is expected to bring about an explosion of performance; In the medium to long term, both pipelines have the potential to disrupt traditional treatments, and Weisheng will leverage its established infrastructure in the field of endocrinology to become the partner of choice for endocrinology treatment options seeking to enter the Chinese market.
What Weisheng Pharmaceutical really wants to do is not simply to pursue the victory of commercialization, but to fill the huge gap in the field of endocrine diseases in China at a deeper level. After all, compared with the fiercely competitive tumor track, the endocrine track still has too many no-man's land, behind which are tens of millions of helpless families and decades of long-term medication.
For high-risk innovative drugs, it is natural to pursue returns, but more importantly, enterprises must have a "benevolent heart". As long as it is a "truly innovative" product that can meet clinical needs, its value will eventually bloom. "The first strand of growth and development" is sailing towards the blue ocean of endocrine.