Chengdu-based Biopharma ConnoMed Announces First NewCo Deal of 2025, Securing Over $360 Million in Potential Value

On January 10, it was announced that Keymed Biosciences Inc. (“Keymed”) had entered into an exclusive license agreement with Timberlyne Therapeutics (“Timberlyne”) regarding CM313, a humanized monoclonal antibody targeting CD38. The agreement was executed by Kang Nuoya Biomedical Technology (Chengdu) Co., Ltd. (“Chengdu Keymed”), a wholly-owned subsidiary of the Group. Pursuant to the license agreement, Keymed granted Timberlyne the exclusive rights to develop, manufacture, and commercialize CM313 globally, excluding China.

In return, Keymed Biosciences will receive a $30 million upfront and near-term payment, along with an equity stake in Timberlyne Therapeutics, becoming its largest shareholder. Upon achieving certain sales and development milestones, Keymed is eligible for additional payments of up to $337.5 million, as well as tiered royalties on net sales, with a cumulative value exceeding $360 million (more than RMB 2.6 billion).

Meanwhile, Timberlyne announced that it had secured a $180 million Series A financing round, led by prominent funds Bain Capital Life Sciences, Venrock Healthcare Capital Partners, and Abingworth, with participation from Boyu Capital, Lilly Asia Ventures, Braidwell, and 3H Health. Upon completion of the Series A financing, Kang Nuoya will hold a 25.79% equity stake in Timberlyne, remaining its largest shareholder.

This is the first Newco deal closed in 2025.

CM313 is a humanized monoclonal antibody targeting CD38 with best-in-class potential. Preclinical studies have demonstrated that CM313 induces potent tumor cell killing via an Fc receptor-dependent mechanism and exhibits a favorable safety profile, with no drug-related clinical signs or off-target effects observed. It is being developed for the treatment of immune thrombocytopenia (ITP).

CD38, the target of CM313, is expressed at low levels in normal bone marrow cells, lymphoid cells, and certain non-hematopoietic tissues, but at high levels in normal plasma cells and multiple myeloma cells, making it a prominent therapeutic target for multiple myeloma (MM). Two CD38 monoclonal antibodies have been approved globally: daratumumab by Johnson & Johnson and isatuximab by Sanofi.

ITP is a rare autoimmune coagulation disorder characterized by two key features: isolated thrombocytopenia, defined as the absence of other hematological parameter abnormalities in peripheral blood cell counts and morphological examinations, and the lack of any signs or clinical symptoms directly attributable to thrombocytopenia. The severity of bleeding symptoms, if present, is generally correlated with the degree of thrombocytopenia.

ITP is a diagnosis of exclusion. Patients who develop thrombocytopenia (defined as a platelet count below 100,000 per microliter) without a clear underlying cause are currently diagnosed with primary ITP. Secondary ITP refers to ITP caused by other diseases or treatments; these conditions include autoimmune disorders, lymphoproliferative disorders, infectious diseases, and transfusion- or drug-induced causes, which collectively account for 20% of ITP cases.

Although the pathophysiological mechanisms of ITP are not fully understood, the key event is considered to be the production of anti-platelet autoantibodies; some studies suggest that cytotoxic T cells can also directly destroy platelets or inhibit their production. In addition, certain ITP patients appear to have triggering events. Genetic and acquired factors may play a role; two commonly cited acquired factors are infections (usually viral) and systemic diseases that disrupt immune homeostasis (such as autoimmune diseases and lymphoid malignancies).

Currently, the first-line treatments for immune thrombocytopenia (ITP) in China are corticosteroids and intravenous immunoglobulin (IVIG). Corticosteroid therapy demonstrates a high initial response rate; however, most patients relapse during tapering or discontinuation, resulting in low sustained remission rates. In contrast, IVIG provides only transient efficacy and is relatively expensive. Thrombopoietin receptor agonists are the preferred second-line treatment for adult patients with relapsed or refractory ITP. These agents typically take effect within 1–2 weeks, with response rates exceeding 60%, but the therapeutic effect is generally not maintained after discontinuation.

Notably, on June 20, 2024, the team led by Zhang Lei and Yang Renchi from the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences), published a research paper titled “A Novel Anti-CD38 Monoclonal Antibody for Treating Immune Thrombocytopenia” in the New England Journal of Medicine (IF=158.5). This study reported, for the first time globally, the findings on the use of CM313, a novel anti-CD38 antibody, in the treatment of immune thrombocytopenia (ITP).

Overall, the study demonstrated that CM313 elicited favorable therapeutic responses in 95.5% of adult patients with primary immune thrombocytopenia (ITP) who had previously undergone multiple lines of treatment. It rapidly and sustainably increased platelet counts, reduced bleeding risk, and exhibited a favorable safety and efficacy profile, offering a highly promising novel therapeutic option. This agent has the potential to bring about revolutionary changes to the treatment paradigm for ITP and similar autoimmune diseases. The completion of this study also marks a breakthrough “from scratch” innovation by Chinese scientists in the field of immune thrombocytopenia, with the potential to reshape global clinical guidelines.

Furthermore, data from the Phase I clinical study of CM313 were presented as a poster at the 28th Annual Congress of the European Hematology Association (EHA). CM313 demonstrated preliminary efficacy in patients with relapsed/refractory multiple myeloma at dose levels ≥2.0 mg/kg, with an overall favorable safety profile.

Furthermore, given the observed superior plasma cell clearance effects of CM313 in multiple myeloma and lymphoma indications, Kang Nuoya has further explored the therapeutic potential of CM313 in systemic lupus erythematosus (SLE) and is actively advancing a randomized, double-blind, placebo-controlled, dose-escalating, multiple-dose Phase Ib/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of CM313 in subjects with SLE.

According to Keymed Biosciences’ official website, the company currently maintains a dual pipeline strategy focused on “autoimmune and chronic diseases + oncology,” with 11 candidate drugs in clinical development or under clinical trial application, including one antibody-drug conjugate (ADC) product. The autoimmune pipeline comprises five investigational products, including its core asset spquibartamab, as well as CM326 and CM338, with R&D progress ranking among the leading domestic peers in the same class. The oncology pipeline includes six investigational products, such as CMG901, CM313, and CM355.

Including this Newco deal, more than half of Kangnuoya’s 11 drug candidates in development have been out-licensed to partners such as AstraZeneca, InnoCare Pharma, and CSPC Pharmaceutical Group, among other renowned domestic and international pharmaceutical companies. This has enabled the company to generate revenue for consecutive years and achieve profitability despite not yet having any commercialized products.

According to its interim business report for 2024, Keymed Biosciences currently holds approximately RMB 2.6 billion in cash, time deposits, and short-term wealth management products. Its revenue for the first half of the year amounted to around RMB 55 million, primarily derived from milestone payments related to the licensing collaboration for CMG901. Notably, the sustainable internal funding and robust cash flow generated through business development (BD) of its innovative pipeline have provided Keymed with the financial confidence to further invest in research and development. In the first half of 2024, the company’s R&D expenses increased by 33% year-on-year, reaching approximately RMB 330 million.

Meanwhile, in 2024, Keymed Biosciences welcomed its first approved drug—sipekimab—marking a new phase in its commercial development. In response, the company’s Chengdu-based production facility has reached a total capacity of 18,600 liters, and it has gradually built a commercialization team of over 190 members.

In July 2024, Keymed Biosciences licensed the global rights (excluding China) for its two novel bispecific antibodies, CM512 and CM536, to Belenos Biosciences (“Belenos”). Under the agreement, Keymed will receive a $15 million upfront payment, $170 million in milestone payments, and tiered sales royalties. Belenos is controlled by the healthcare-focused investment fund OrbiMed, which holds a 50.26% stake; Yiqiao Hong Kong, a wholly-owned subsidiary of Keymed, holds a 30.01% stake. Chen Bo, Chairman of Keymed, will join the Board of Directors of Belenos.

On November 17, Chengdu Kangnuoya entered into an exclusive license agreement with Platina Medicines Ltd (PML). Under the agreement, Kangnuoya granted PML an exclusive global license (excluding China) to develop, manufacture, and commercialize the candidate drug CM336. Reportedly, Kangnuoya received $16 million in upfront and near-term payments, and also acquired a minority equity stake in Ouro Medicines (PML’s parent company, which holds 100% of PML’s equity) as part of the consideration.

Furthermore, upon the achievement of certain clinical, regulatory, and commercial milestones, Keymed Biosciences is eligible to receive additional payments of up to $610 million and is entitled to receive tiered royalties on net sales. (Note: The total transaction value amounts to $626 million, equivalent to approximately RMB 4.527 billion.)

As a representative active player in Newco, Kelun-Biotech also clearly stated in its 2024 interim results report that it will continue to rapidly advance the clinical development of its pipeline products in China and globally, while preparing for the commercialization of late-stage pipeline assets. To maximize the commercial value of its drug candidates, Kelun-Biotech will also actively explore value-added strategic partnerships, such as co-development, collaborations, and licensing arrangements.

As Keymed Biosciences fired the first shot for Newcos in 2025, and with domestic innovative pharmaceutical companies such as Hengrui Medicine and Haisco Pharmaceutical having validated this overseas expansion pathway through practice, an increasing number of biotech founders are exploring the NewCo model, despite existing challenges.