Breaking Down Betta Pharmaceuticals Co., Ltd. Financial Health: Key Insights for Investors

Born in 2003 from a team of returnee PhD pioneers, Betta Pharmaceuticals (trading as 300558.SZ) has grown into a China-focused oncology innovator whose milestones - the 2011 launch of Conmana® (icotinib) as the country's first domestically developed small‑molecule targeted therapy, a 2016 Shenzhen Stock Exchange listing, the 2020 approval of Ensacove® (ensartinib), the 2021 rollout of its first biologic Bevacizumab injection, and the 2023 approval of third‑generation EGFR‑TKI Befotertinib - illustrate a fast‑moving pipeline and commercial evolution; backed by founder and CEO Dr. Lieming Ding, a workforce of over 1,700 employees (including roughly 500 R&D professionals), 299 patents and some 800 scientific publications, the company posted 2.89 billion CNY revenue in 2024 (up 17.74% year‑over‑year), commands a market capitalization of about 20.07 billion CNY (as of December 12, 2025), and has generated over 13 billion CNY in accumulated Conmana® sales serving more than 500,000 patients - a profile that ties its integrated R&D‑to‑commercial model, heavy reinvestment in innovation (R&D expense >40% of total spend), and 14 clinical candidates plus 20+ preclinical molecules to an expanding role in China's oncology market and growing global partnerships.

Betta Pharmaceuticals Co., Ltd. (300558.SZ): Intro

• Founded: 2003 by returned PhD founders
• Listing: Shenzhen Stock Exchange, Nov 2016 (300558.SZ)
• Headquarters: China (multiple R&D and manufacturing sites)
• Therapeutic focus: Oncology (NSCLC, colorectal cancer), targeted small molecules, biologics

• 2003-2010: Core team built R&D platform, focused on kinase inhibitors for oncology.
• 2011: Conmana® (icotinib) commercialized domestically; established Betta as a player in targeted NSCLC therapy.
• 2016: Public listing (300558.SZ) provided capital for scale-up of clinical pipelines and manufacturing.
• 2020-2023: Transition from small molecules to first-in-class/Category 1.1 approvals and entry into biologics (Bevacizumab) and third-generation EGFR inhibitors (Befotertinib).

• Discovery & preclinical: internal medicinal chemistry and translational biology teams (early drug candidates generated in-house).
• Clinical development: conducts multi-center domestic and selected international trials; leverages expedited regulatory pathways for oncology candidates.
• Manufacturing: combination of in-house GMP facilities and CMOs for biologics and small-molecule production.
• Commercialization: direct sales force in oncology hospital channels, tender and provincial reimbursement negotiations; lifecycle management through label expansions and combination trials.

• Conmana® (icotinib): early revenue driver in EGFR-mutated NSCLC in China after 2011 launch.
• Ensacove® (ensartinib): positioned for ALK-positive advanced NSCLC after 2020 approval as a Category 1.1 new drug in China.
• Bevacizumab injection: represents Betta's entry into biologics (approved 2021 for colorectal cancer and advanced NSCLC).
• Befotertinib (Surmana®): third-generation EGFR-TKI approved May 2023 for T790M-positive advanced/metastatic NSCLC.

• Core revenue streams:
  • Sales of marketed oncology drugs (hospitals, oncology centers).
  • Contract manufacturing and development services (selected molecules/biologics).
  • Licensing, co-development and milestone payments from local/international partnerships.
• Go-to-market approach: hospital prescribing channels, provincial reimbursement listings, participation in national drug procurement and inclusion in NRDL negotiations for price-volume access.

• IPO: Listed Nov 2016 on SZSE under 300558.SZ - proceeds used to expand R&D and manufacturing capacity.
• Pipeline breadth: multiple late-stage oncology candidates including EGFR and ALK inhibitors and at least one marketed biologic (Bevacizumab).
• R&D intensity: industry practice for innovative Chinese biopharma peers is R&D-to-revenue ratios in mid-to-high teens or higher; Betta has consistently prioritized clinical development spending to advance Category 1.1 and novel approvals.

• Publicly listed entity with institutional, retail and management shareholders after the 2016 IPO.
• Founders and senior management historically hold meaningful stakes and seats on the board, aligning strategic R&D focus with long-term value creation.
• Corporate governance aligned with Shenzhen Stock Exchange disclosure requirements and periodic annual/quarter reports.

• Domestic competitive advantages: first-mover benefits for some domestically developed targeted therapies (e.g., Conmana), regulatory experience with Category 1.1 approvals, growing biologics capability.
• Challenges: competition from multinational oncology franchises, pricing pressure from national procurement, need to defend and expand label indications.

• Conmana (2011): validated Betta's R&D-to-market execution capability.
• IPO (2016): enabled R&D scale-up and capacity investments.
• Ensacove (2020) and Bevacizumab (2021): strategic diversification into both novel targeted agents and biologics.
• Befotertinib (Surmana®, 2023): strengthened late-line EGFR franchise for T790M-positive NSCLC.

Betta Pharmaceuticals Co., Ltd. (300558.SZ): History

• Listing: Shenzhen Stock Exchange - ticker 300558.SZ
• Founder & leadership: Dr. Lieming Ding - Chairman & CEO; major individual shareholder
• Market capitalization (as of 12 Dec 2025): ~20.07 billion CNY
• Employees: >1,700, with a substantial portion holding advanced degrees (including PhDs)
• Ownership composition: mix of institutional and individual investors with freely traded shares

• Selected strategic partners: Xcovery LLC., Merus N.V., Agenus Inc.
• Collaboration focus areas: antibody therapeutics, oncology immunotherapy, discovery-stage licensing

Betta Pharmaceuticals Co., Ltd. (300558.SZ): Ownership Structure

• Mission: 'Better Medicine, Better Life' - translating advanced science and technologies into innovative, affordable medicines to improve patient outcomes in China and internationally.
• Patient-centric focus: prioritize unmet medical needs and access to treatment through value-driven product design and pricing.
• Scientific excellence: sustained investment in R&D, with integrated capabilities across discovery, clinical development, manufacturing and commercialization.
• Integrated model: R&D → manufacturing → marketing to shorten time-to-market and control product quality and cost.
• Innovation ecosystem: supports external entrepreneurship and early-stage science via Betta Dreamworks incubator to accelerate translational projects and partnerships.

• Business model: discovery and development of prescription medicines (small molecules, biologics), in-house manufacturing and nationwide commercial distribution to hospitals and retail channels.
• Revenue streams: product sales (domestic Rx), licensing and collaboration fees, contract manufacturing and technology transfer income.
• R&D strategy: pipeline prioritization around oncology, cardiovascular/metabolic and hospital-administered therapies; in-house clinical capabilities to progress assets through late-stage trials.
• Commercial execution: national sales force, provincial distributors and hospital formularies to drive uptake of core products.

• Expand high-value hospital products and oncology portfolio to capture hospital tender and NRDL opportunities.
• Scale manufacturing capacity to support biologics and complex generics while lowering unit cost.
• Use Betta Dreamworks to source external innovation and de-risk early-stage programs via partnerships and licensing.
• Maintain double-digit revenue growth through new product launches and deeper market penetration.

Betta Pharmaceuticals Co., Ltd. (300558.SZ): Mission and Values

• Integrated R&D-to-commercialization value chain: discovery, nonclinical, clinical, CMC, regulatory, manufacturing, sales and marketing.
• Global research footprint with R&D centers in Hangzhou and Beijing (China) and San Diego (USA) to support cross-border discovery and clinical collaboration.
• Dedicated research institute and on‑site clinical research facilities capable of advancing programs from target identification through NDA/BLA submission.
• R&D team of approximately 500 professionals - many holding doctoral degrees - working across small molecules, biologics, formulation and clinical sciences.
• Emphasis on external alliances: in‑depth collaborations with academic institutions, biotech partners and CRO/CMO networks to accelerate pipeline programs and technology transfer.

• Completed 10 key projects designated as 'National Important New Drug Development'.
• Intellectual property portfolio: 299 patents granted/owned.
• Scientific output: ~800 peer‑reviewed publications supporting discovery and translational programs.

• Core revenue streams: marketed pharmaceuticals (proprietary and partnered), contract manufacturing and technology transfer, licensing and milestone income, and collaborative R&D services.
• Value creation levers: advancing innovative assets to first-in-market/first-in-indication status, scaling commercial manufacturing, and out-licensing late‑stage assets for global roll‑out.

• Positions itself as a hub in China's innovative drug ecosystem by combining internal discovery with external partnerships (academia, biotech, CRO/CMOs, global pharma).
• Leveraging San Diego presence for US/West-coast scientific collaboration and early-phase clinical ties.

Betta Pharmaceuticals Co., Ltd. (300558.SZ): How It Works

• Listed on the Shenzhen Stock Exchange (300558.SZ).
• Ownership comprises institutional investors, public float, and founding management; strategic partnerships and licensing agreements expand off-balance-sheet reach.

• In-house discovery and clinical development of targeted oncology agents (small molecules and biologics).
• GMP manufacturing capability and third‑party contract manufacturers for scale-up.
• Commercial salesforce and hospital distribution channels across China; selective overseas partnering/licensing for international markets.

• Core product sales: Conmana® (icotinib hydrochloride), Ensacove® (ensartinib hydrochloride), Bevacizumab injection, and other oncology portfolio drugs.
• Lifecycle revenue from mature products (e.g., Conmana®) combined with growth from newer launches and hospital formulary adoption.
• Out-licensing, co-development and strategic partnerships that provide milestone and royalty income.
• Reinvestment into clinical programs-R&D spend is a major operating outflow to sustain pipeline expansion.

• Strategic collaborations: Xcovery LLC, Merus N.V., Agenus Inc., among others-these partnerships provide access to external assets, co-development, and potential global commercialization.
• Partnering model: in-licensing for China rights, co-development agreements, and out-licensing for ex-China territories to capture milestones and royalties.

• Conmana® has provided treatment to over 500,000 patients in China, underpinning the company's commercial credibility and recurring prescription base.
• Revenue mix blends mature product cashflow (Conmana®) with growth potential from Ensacove® and biologics such as bevacizumab formulations.

Betta Pharmaceuticals Co., Ltd. (300558.SZ): How It Makes Money

• Core commercial sales: marketed targeted oncology therapies (notably in NSCLC) and specialty products marketed in China.
• Out-licensing and milestone payments: partnerships with domestic and international pharma firms for co-development, licensing and regional distribution.
• Co-development and collaboration revenue: R&D collaborations that include upfront fees, development milestones and future royalties.
• Contract manufacturing and supply agreements: supplying APIs and finished dosage forms under third‑party agreements for strategic partners.
• Government/insurance reimbursement-driven uptake: revenue growth supported by inclusion of select drugs in provincial and national reimbursement lists.

• Pipeline composition: the portfolio spans small molecule TKIs, novel NME classes and ophthalmology formulations - with multiple NME candidates currently in Phase I.
• Clinical & commercial strategy: move candidates from Phase I/II into registration trials while preparing manufacturing scale-up to capture market share upon approval.
• Partnership strategy: expanding market presence through strategic alliances for co-development, regional registration and commercialization to accelerate uptake and de‑risk development costs.