Ask AI · Mivway Bio’s revenue surge relies on BD licensing—how sustainable is it?

Mivway Bio, which recently disclosed a new plan to list in Hong Kong, has released a solid annual report: in 2025, the company achieved operating revenue of RMB 663 million, up 231.62% year over year, setting a new record for its revenue growth rate since its listing.

The revenue jump sounds astonishing, but the reality is that most of the revenue comes from two one-off BD licensing deals, which make up the company’s main growth driver. Last year, Mivway Bio’s license and service fee revenues from companies such as Qilu Pharmaceutical and DISC reached RMB 408 million. After stripping out this portion, the sales revenue from the company’s actual commercialized products was RMB 249 million, up 72.71% year over year. Since the base was relatively low last year, this performance falls within a relatively normal range.

You need to know that in 2021, Mivway Bio had estimated in its STAR Market IPO prospectus: the commercialization sales of its biopharmaceutical products in 2025 should be between RMB 1.1 billion and RMB 1.7 billion. Actual sales failed to reach even 25% of the forecast for that year.

Because sales fell short of expectations, Mivway Bio’s 2025 loss totaled as much as RMB 969 million. And due to continued high R&D spending, the company is still in a “small horse pulling a large cart” situation: over the past 9 years, it has accumulated losses of nearly RMB 6.7 billion; behind it are more than a dozen in-development pipelines “waiting for feeding,” while the cash flow on the books is negative.

Mivway Bio urgently needs fresh cash to come in. Last January and August, the company submitted applications to the Hong Kong Stock Exchange twice, but both ended in becoming invalid. On March 25, at the same time as Mivway Bio released its performance results, it submitted an IPO application to the Hong Kong Stock Exchange for the third time, hoping to ride the surge in its performance to get listed.

Biosimilars: the “monetization ceiling” has already appeared

In 2025, Mivway Bio’s four listed products generated RMB 249 million in revenue, accounting for about 30% of total revenue—up significantly year over year. Therefore the company increased production volume by nearly 50% last year, indicating that strong market demand is likely to continue.

The core growth driver comes from two biosimilars of denosumab: Mylishu and Mweijian. The original denosumab injectable is by Amgen. The two analogous products from Mivway Bio have different dosages and different therapeutic indications. The 60mg formulation, Mylishu, focuses on the osteoporosis market, while the 120mg formulation, Mweijian, targets the bone giant cell tumor field. Last year, the combined sales revenue of the two drugs was RMB 206 million, up 48.59%.

In biosimilars of denosumab, Mivway Bio has an absolute advantage. In March 2023, Mylishu was approved for marketing, becoming the world’s second biosimilar of Amgen’s denosumab “Prolia.” The following year, Mweijian was also approved for marketing, becoming China’s first approved biosimilar of Amgen’s denosumab “Xgeva.”

This was originally a great hand. According to data provided by IQVIA, in 2024 denosumab products sold about $7.463 billion globally. But unfortunately, domestic companies quickly crowded in—Feiyang Biologic, Qilu Pharmaceutical, Boan Biologic, Fosun Pharma, and others have been racing to follow. Even though Mivway Bio has a first-mover advantage, its commercialization capabilities are definitely not as strong as these companies, making it difficult to win in the competition.

Denosumab is not yet the most intensely competitive category. Mivway Bio also has another denosumab biosimilar jointly developed with Innovent Biologics: the adalimumab biosimilar “JUN MIVWAY”—this is what it looks like when you get trapped in a circle of encirclement. In China, besides the original maker AbbVie, there are already companies such as Biotech/BeoTai Biotech, Hisun Pharmaceutical, Innovent? (Cinda Biologics?) (and other) including Concord? Hanlin?—all of which have adalimumab biosimilar drugs. “Junmaikang” has long stopped selling well; shipments dropped from 166.9 thousand doses in 2023 to just 48.8 thousand doses in 2024. Last year, Mivway Bio took the B certificate and MAH qualifications for “Junmivway” into its own hands, and the company also expects that the market will not see much improvement.

In addition, the centralized procurement price cuts for biosimilars are like the “Sword of Damocles” hanging over Mivway Bio’s head; it will eventually fall. Adalimumab and denosumab are both products that they cannot avoid.

Last year, Mivway Bio launched an innovative drug, the injection of aggresitap α “Mylili.” This was the first G-CSF drug approved in China developed using an albumin long-acting fusion technology, mainly used to treat complications caused by treatment-induced severe neutropenia in cancer patients. Because the drug only began selling in December last year, the performance should show up in 2026. Public information indicates that the long-acting white-blood-cell-raising drug market could reach RMB 13.537 billion by 2030. “Mylili” may become an important future performance support for Mivway Bio.

Relying on BD to quench thirst isn’t a long-term solution

Mivway Bio’s listed products have limited highlights; instead, the pipeline products are more eye-catching.

The project with the largest funding input is a Nectin-4 ADC, code 9MW2821. This year, key results for indications such as urothelial carcinoma, cervical cancer, and triple-negative breast cancer are expected to be disclosed, and it could become the first approved Nectin-4 ADC made in China, with the earliest expected approval for marketing in 2028. The company estimates that for just two indications—urothelial carcinoma and cervical cancer—domestically, annual sales could exceed RMB 3 billion.

Other major pipeline products include B7-H3 ADC, Trop-2 ADC, CD47/PD-L1 bispecific antibodies, ST2 monoclonal antibody, TMPRSS6 monoclonal antibody, IL-11 monoclonal antibody, and more. The annual report also discloses that among its major in-development products, carrying out preclinical research, clinical trials, and preparations for new drug launches still requires large-scale R&D investment.

Mivway Bio’s R&D spending last year hit a new high of RMB 977 million. Relying solely on biosimilar revenue clearly cannot cover costs, so the company urgently needs to expand the revenue end. At present, the company can only rely on channels such as BD and external financing to quickly obtain funds. The RMB 408 million authorization licensing and service fee revenue last year largely alleviated Mivway Bio’s funding stress.

In June 2025, backed by “Mylili,” the company previously reached a BD deal with Qilu Pharmaceutical and, in the third quarter of the previous year, received a one-time non-refundable upfront payment of RMB 380 million from Qilu Pharmaceutical, which directly boosted revenue for that quarter, up 1717.41% year over year.

In June last year, Mivway Bio also signed an exclusive licensing agreement with CALICO for its self-developed IL-11 monoclonal antibody 9MW3811. Under the agreement, the former can receive a one-time non-refundable upfront payment of $25 million and up to $571 million in milestone payments. Three months later, the company reached an agreement with Kalexo for a cardiovascular double-target siRNA innovative drug 2MW7141, with a cooperation amount of up to $1 billion.

But with only upfront payments, the distant water still can’t quench immediate thirst. Mivway Bio is well aware of this, and while performance is surging, it submitted its Hong Kong stock IPO application for the third time. However, the Hong Kong market is not easy to get into. Last year, more than 70 biopharmaceutical companies submitted applications to the Hong Kong Stock Exchange; after removing the companies that have already passed the hearing, there are still about 65 companies queued for review.

. Mivway Bio does not know how long it will have to wait.

Written by丨Miao Miao

Edited by丨Jiang Yun, Jia Ting

Operations丨Twenty-Three

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