Double Milestone: Two ADCs Enter Clinical Trials, Stock Surges 126% in a Year

On February 18, Mabwell (688062.SH) announced that its investigational B7-H3-targeting antibody-drug conjugate (ADC), code-named 7MW3711 and independently developed based on its next-generation site-specific conjugation technology platform IDDC™, has officially received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application, allowing clinical trials to proceed in patients with advanced malignant solid tumors.

7MW3711 comprises an innovative antibody molecule, a novel linker, and a novel payload (a topoisomerase I inhibitor). Upon administration in humans, it binds to the B7-H3 antigen on the surface of tumor cells and is internalized via endocytosis. Through specific enzymatic cleavage, it selectively releases the small-molecule payload, thereby achieving precise tumor cell killing.

7MW3711 is characterized by structural stability, homogeneous composition, high purity, and ease of industrial scale-up. Compared with similar drugs both domestically and internationally, 7MW3711 has demonstrated superior tumor-killing efficacy in various animal tumor models. In safety evaluation models using animals such as cynomolgus monkeys, 7MW3711 has exhibited favorable drug safety and pharmacokinetic profiles.

On February 18, Mabwell enjoyed a “double celebration.” In addition to officially announcing that its 7MW3711 pipeline had received FDA approval to enter clinical trials, the company also announced that the U.S. FDA had granted Orphan Drug Designation (ODD) to 9MW3011 (U.S. development code: MWTX-003/DISC-3405), a macromolecular regulator of iron homeostasis. This pipeline had also received FDA Fast Track designation last September.

In fact, as early as July last year, Mabwell’s B7-H3-targeting antibody-drug conjugate (ADC) 7MW3711 received approval from the National Medical Products Administration (NMPA) to initiate clinical trials in patients with advanced malignant solid tumors, marking its entry into the clinical development stage in China. Additionally, in July of the same year, Mabwell’s Trop-2-targeting ADC 9MW2921 also obtained NMPA approval for clinical trials in patients with advanced solid tumors.

According to the press release issued by Mabwell, the company expects multiple antibody-drug conjugate (ADC) candidates to enter clinical development between 2023 and 2024. Mabwell is poised to become a major new force in the highly competitive ADC landscape, generating significant momentum in this specialized sector.

This “whirlwind” is undoubtedly a significant driver behind Mabwell’s surge in the A-share market.In 2023, Mabwell delivered outstanding performance in the capital markets. Calculated based on the closing price of RMB 14.45 per share on December 30, 2022, and the closing price of RMB 32.69 per share on December 29, 2023, Mabwell’s stock price surged by 126.23% in 2023, far exceeding the 5.89% annual gain of the biological products sector and ranking first in the sector.

Mabwell, a pharmaceutical newcomer established in 2017, has rapidly built capabilities in research and development, manufacturing, and commercialization in recent years through acquisitions, integration, and self-development.

It is worth noting that Mabwell’s independently developed IDDC™ technology platform comprises several systematic core patented technologies, including the site-specific conjugation process DARfinity™, the site-specific linker IDconnect™, the novel payload molecule Mtoxin™, and the conditionally releasable structure LysOnly™. Next-generation ADC drugs developed based on these systematic patented technologies exhibit superior structural homogeneity, quality stability, efficacy, and tolerability.

Leveraging this technology platform, Mabwell has developed multiple ADC product pipelines, including 9MW2821, an innovative Nectin-4-targeting ADC currently in Phase II clinical trials.9MW2821 is the first Nectin-4-targeting ADC drug to enter clinical trials in China and the second globally.Globally, Padcev (enfortumab vedotin), co-developed by Seagen and Astellas, is currently the only approved drug targeting this same mechanism. The product achieved global sales of $798 million in 2022 and $466 million in the first half of 2023, demonstrating significant market potential.

In addition to ADCs, Mabwell has also established a presence in the field of biosimilars, creating a combined strategy that can provide the company with a certain degree of financial resilience.Furthermore, unlike most biotech companies—especially ADC developers—that opt for CDMOs for manufacturing, Mabwell has established its own in-house production system since its inception, with manufacturing bases currently located in Taizhou, Jiangsu Province, and Jinshan, Shanghai.

This represents the most significant distinction between Mabwell and conventional biotech companies, as it operates more like a hybrid entity combining the operational models of both pharmaceutical companies (Pharma) and biotechnology firms (Biotech). Mabwell possesses comprehensive R&D and innovation capabilities spanning target identification, molecular discovery, preclinical development, and clinical research, while strategically positioning itself in large-scale, high-growth therapeutic areas such as oncology, autoimmune diseases, ophthalmology, and infectious diseases.

The company currently has 14 product candidates at various stages of development, including 10 innovative drugs and 4 biosimilars. Among these, Junmaikang (adalimumab) and Mailishu (denosumab for the indication of osteoporosis) have been successfully launched. The New Drug Applications (NDAs) for 9MW0321 (denosumab for the indication of bone metastases) and 8MW0511 (long-acting G-CSF) have been accepted for review, while three additional candidates are in pivotal registration clinical trials. Furthermore, the company independently undertakes one national major science and technology special project on “Major New Drug Development,” two national key R&D programs, and multiple provincial and municipal technological innovation projects.

In addition to the milestone progress in pipelines drawing significant industry attention, terms such as “BD,” “going global,” “collaboration,” and “M&A” have also become key focal points in the current capital environment.

On one hand, biotech companies typically excel in R&D and early-stage clinical development, demonstrating considerable flexibility. On the other hand, biotechs that have not yet achieved large-scale commercialization of their products lack the capital necessary to support long-term R&D, as well as the resources and experience required for late-stage development, clinical trials, and commercialization, making it difficult for them to successfully bring drug candidates to market independently. This is where pharmaceutical partnerships prove most valuable. Pharmaceutical partners can provide the resources, expertise, and infrastructure needed for R&D, help overcome hurdles in clinical development, expand the geographic reach of biotech companies, and even share commercialization costs, thereby making large-scale production and distribution more feasible.

In terms of collaboration, Mabwell differs from typical biotech companies, pursuing a rather “unconventional” path to global expansion.Currently, the preferred initial overseas markets for most domestic pharmaceutical companies are countries and regions with relatively advanced pharmaceutical technologies or strong payment capabilities, such as Europe and the United States.

As a global enterprise, Mabwell has naturally established its overseas presence in Europe and the United States. According to available data, as of the first half of 2023, Mabwell had signed multiple out-licensing agreements for candidates in clinical development, including 8MW0511, 9MW1111, and 9MW3011. The cumulative value of these agreements amounted to RMB 3.56 billion, with additional entitlements to sales royalties post-commercialization.

In addition to actively expanding into European and American markets, Mabwell is also targeting emerging markets such as South America and countries along the “Belt and Road” initiative. Public information indicates that Mabwell has already entered into cooperation agreements with pharmaceutical companies in several “Belt and Road” countries, including Searle in Pakistan, Sothema in Morocco, and UNILAB in the Philippines.

In January this year, according to Mabwell’s official website, the company announced that regarding Mai Li Shu^®(Denosumab Injection, Prolia^®Biosimilar) entered into a licensing and commercialization agreement with an Indonesian pharmaceutical company.Under the agreement, the joint venture company has been granted exclusive rights to register, import, market, and sell the product in Indonesia.

Mabwell^®Approved for marketing by the National Medical Products Administration (NMPA) of China in March 2023, the partner company will be responsible for submitting its marketing application in Indonesia. Previously, Mabwell had granted its Junmaikang^®(Adalimumab Injection, Humira^®exclusive distribution rights for biosimilars) in the Indonesian market. We look forward to Mabwell bringing more high-quality, highly accessible biologics to local patients in Indonesia, a key Southeast Asian market with a population of approximately 275 million.

It is evident that Mabwell’s product portfolio and overseas expansion strategy are somewhat “unconventional.” Yet, in the pharmaceutical industry, where survival rates are notoriously low, this may well be Mabwell’s key to thriving amidst the fierce competition. We look forward to more biotech companies following Mabwell’s lead, introducing differentiated strategies to foster a healthy and vibrant market environment.

References:
1. Feijing Investment Research: "Revenue Surges Sevenfold, Gross Margin Exceeds 95%—Higher Than Kweichow Moutai’s—a Small Yet Beautiful Company with a Market Cap Under RMB 10 Billion!"

2. Yaozhi Network: “The ‘ADC Rising Star’ Whose Stock Price Soared 119%”