April 17, 2026
Source: drugdu
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Late night on April 14, Bio-Thera Solutions issued an announcement stating that it would transfer Bevebatide Citrate Injection (Betanin), its Class 1 innovative drug that had been on the market for only 15 months, to Lepu Pharmaceutical, a subsidiary of Lepu Medical, for a total price of 450 million yuan.
This "major new drug development" project, which once embodied the company’s ambition to expand into innovative drugs, has been wholly divested together with its marketing authorization, intellectual property rights, and commercialization interests.
On April 14, prior to the announcement, Bio-Thera’s share price surged 5.96% in a single day, showing a clear signal of capital inflow. On the day following the announcement, the stock plunged 6.14%, with trading volume nearly doubling to a phased peak. Behind the sharp divergence between long and short positions lies the market’s re-evaluation of the nature of the deal: this is not a simple asset disposal, but a tough trade-off for a biotech firm between cash flow pressure and strategic focus.
In 2025, Bio-Thera recorded revenue of 934 million yuan, a net loss of 336 million yuan, and an asset-liability ratio of 78.27%. Betanin was on the market for less than 11 months throughout the year, contributing an extremely low share of total revenue, yet continuously consuming resources for R&D, production, and commercialization. More crucially, Bio-Thera’s core strengths have long been concentrated in oncology and autoimmunity, with no specialized cardiovascular promotion team. Faced with competition from mature centralized procurement drugs such as aspirin and clopidogrel, this innovative drug — priced at 1,290 yuan per pen and not covered by medical insurance — has failed to gain meaningful market traction.
Selling its only innovative drug seems contradictory, yet it reflects an evolution of the survival rules for biotechs: as the industry shifts from a "pipeline quantity race" to "cash flow safety first", cutting inefficient assets and focusing on core sectors has become more urgent than clinging to an illusory innovative drug halo. Bio-Thera’s choice may well epitomize the collective "streamlining" trend among Chinese biotechs.
01
Betanin: Halo and Predicament
The Reality Gap of an Innovative Drug
According to Bio-Thera’s announcement:
• The subject of the transfer includes Betanin’s marketing authorization, intellectual property rights, production technology, and full commercialization rights. The total transaction value is 450 million yuan (tax-inclusive), payable in five installments, with full settlement upon approval of MAH (Marketing Authorization Holder) and production transfer. Bio-Thera may also receive single-digit percentage sales royalties on Betanin’s annual net sales for up to 10 years.
• Betanin is a prescription drug indicated for patients with acute coronary syndrome undergoing PCI, to reduce the risk of thrombotic and other complications.
• Betanin contributed an insignificant proportion of the company’s total revenue in 2025, and its divestment will not affect core business. The company will optimize asset allocation, focus on core operations, improve asset efficiency, and expects a positive impact on its financial position to support the implementation of its core strategy. The transaction is fairly priced and does not harm the interests of the company or its shareholders.
Founded in Guangzhou in 2003, Bio-Thera completed its shareholding reform in March 2019 and clarified its strategy--building a foundation with biosimilars and pursuing innovative drugs as a long-term goal, focusing on major disease areas including oncology, autoimmunity, cardiovascular diseases, and ophthalmology.
July 2003: Bio-Thera Solutions (Guangzhou) Co., Ltd. was established, embracing the philosophy of "Innovation for Life" with a clear focus on innovative drug R&D.
October 2016: BAT8001, its first ADC innovative drug, received clinical trial approval, officially launching innovative oncology R&D and paving the way for post-PD-1 tumor immunotherapy.
After 2021: Multiple innovative drugs entered pivotal clinical stages.
Currently, Bio-Thera has 5 marketed products:
·4 approved by China NMPA:Golieli® (adalimumab), Pubexi® (bevacizumab), Siruili® (tocilizumab), and Betanin® (bevebatide citrate).
·3 approved by the U.S. FDA:TOFIDENCE® (tocilizumab), Avzivi® (bevacizumab), and STARJEMZA® (ustekinumab).
·3 approved by the EU EMA:BAT1806 (tocilizumab), Avzivi® (bevacizumab), and Usymro® (ustekinumab).
· 1 approved by Brazil’s ANVISA:Bevyx® (bevacizumab).
Betanin is Bio-Thera’s only self-developed innovative drug on the market, as well as its sole cardiovascular product.
It is the first domestically approved β3 integrin receptor inhibitor in China and a project supported by the National Major Scientific and Technological Special Project for "Major New Drug Development".
The drug carries clear clinical value: it simultaneously inhibits platelet aggregation and vascular smooth muscle proliferation, reducing the risk of thrombosis, restenosis, and other complications after PCI. Phase III clinical data showed it reduced the 30-day post-operative composite endpoint risk by 43% with a lower risk of severe bleeding. In terms of market potential, China’s ACS drug market reached 17.297 billion yuan in 2025, with the global market exceeding 62 billion yuan — suggesting Betanin should have enjoyed considerable commercial prospects.
As a key milestone in Bio-Thera’s push into innovative drugs, Betanin’s launch once validated the company’s capabilities in innovative R&D, clinical registration, and commercial preparation. However, after market launch, the drug never achieved the expected sales growth.
Betanin only made its first shipment in January 2025, with a sales cycle of less than 11 months for the full year, still in the market introduction phase and contributing negligible revenue. Its price of 1,290 yuan per pen, exclusion from the medical insurance catalog, and the hospital zero-markup policy have weakened procurement willingness among medical institutions, kept patients’ out-of-pocket costs high, and hindered clinical penetration.
China’s PCI perioperative antithrombotic market is already highly competitive. Mature drugs such as aspirin, clopidogrel, and ticagrelor have undergone centralized procurement with prices as low as tens of yuan, and physicians’ prescription habits are deeply entrenched, making it difficult for Betanin to gain market share. Bio-Thera’s core strengths lie in oncology and autoimmune diseases, lacking a cardiovascular sales and medical promotion team to match the drug’s market positioning.With a target population of only 13,100 to 32,400 patients per year, Betanin’s market ceiling was limited from the start.
For Bio-Thera, the drug continued to absorb R&D, production, and commercial resources without delivering commensurate revenue, becoming an inefficient asset dragging down overall development.
02
Bio-Thera’s Strategic Trade Off
Still Betting on Innovative Therapies?
Once listed on the STAR Market in 2020, Bio-Thera was dubbed “the first listed company of China’s biosimilars”.
In 2025, the company recorded revenue of 934 million yuan, yet posted a net loss of 336 million yuan, with an asset liability ratio as high as 78.27%. For biotech firms, cash flow security and efficient resource allocation matter far more than maintaining an overly broad pipeline.
The disposal of Betanin has not only optimized the company’s asset structure but also unlocked capital inflows to support its core businesses.
From a strategic perspective, Bio-Thera has realigned its pipeline focus: it exited the cardiovascular therapy area and concentrated R&D on three core fields — autoimmunity, oncology, and ophthalmology. Meanwhile, innovative drugs now account for nearly 69% of its pipeline, with its oncology portfolio almost entirely composed of innovative therapies, marking a departure from the previous multi sector scattered development model.
In 2025, Bio-Thera reduced its total loss by 174.1473 million yuan year on year, and its net loss attributable to parent company shareholders narrowed by 173.8629 million yuan, mainly driven by revenue growth to 934 million yuan.
On one hand, the company expanded market penetration, with steady sales growth for adalimumab injection (Goleli®) and tocilizumab injection (Siruili®) compared with the previous year.
On the other hand, ustekinumab injection (STARJEMZA®) was launched in the United States during the reporting period, driving growth in licensing and sales revenue.
With a solid biosimilar foundation, its innovative drug pipeline is set to gradually become the main growth driver. The sale of Betanin may well be a pivotal step for Bio-Thera to concentrate resources on breakthroughs in innovative therapies.
Today, one out of every two new clinical investigational drugs worldwide comes from China, placing Chinese innovative pharmaceuticals in the global first echelon. Yet the industry suffers from severe internal competition. Amid industry consolidation, the Matthew Effect continues to intensify.
The landscape of top tier players has become relatively stable, with at least six pharmaceutical companies exceeding 10 billion yuan in revenue in 2025:
• BeiGene: 37.77 billion yuan, CSPC Pharmaceutical Group: 26.006 billion yuan, Hengrui Medicine: 16.342 billion yuan, China Biologic Products: 15.52 billion yuan, Hansoh Pharmaceutical: 12.354 billion yuan, Innovent Biologics: 11.896 billion yuan.
The market size for innovative drugs continues to expand, with broad long term prospects. In early 2026, national policies clarified the industry’s direction: pricing of innovative drugs will be determined by market supply and demand, with exclusivity, uniqueness, and scarcity as core pricing leverage.
On April 14, the General Office of the State Council issued the Guiding Opinions on Improving the Drug Price Formation Mechanism, emphasizing that drug pricing shall be centered on clinical value. High level innovative drugs may command prices reflecting high R&D investment, while low value pipelines will have no premium space.
The new policy sends a clear signal: the pharmaceutical industry no longer supports “pie spreading” pipeline expansion. Resources and policy support will tilt toward pipelines with high clinical value and high quality. Mechanisms including normalized centralized procurement, medical insurance payment orientation, and online price management are forcing pharmaceutical companies to eliminate inefficient pipelines and focus on core sectors.
Industry data corroborates this trend. In the first quarter of 2026 alone, the total value of out licensing transactions for Chinese innovative drugs exceeded 60 billion US dollars, nearly half of the full year 2025 total. Among 49 overseas BD deals, 12 featured upfront payments exceeding 100 million US dollars. CSPC Pharmaceutical Group even closed a landmark 18.5 billion US dollar transaction with a 1.2 billion US dollar upfront payment. All these high value transactions concentrated on cutting edge, high quality pipelines such as ADCs, bispecific antibodies, and first in class drugs.
The choices of global capital and pharmaceutical companies have made it evident: pipeline quality outweighs quantity. Only innovative drug developers that focus on their core strengths and deepen cutting-edge R&D can gain recognition from the market and the industry.
From “the first listed company of China’s biosimilars” to actively spinning off non core innovative drugs, Bio-Thera has abandoned the superficial glory of pipeline quantity and returned to the essence of an innovative pharma company: deploying limited resources to deliver the most valuable innovations.
As the innovative drug industry moves toward high quality development, the era of blind expansion and scattered multi line layout is over.Streamlining pipelines, concentrating on main businesses, and deepening competitive domains have become not only the foundation of corporate survival but also the only path to greater strength.
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