QinheLi Announces Completion of Series A+ Financing to Accelerate Development of Innovative Oncology Pipeline

AFFINITY recently announced the completion of its Series A+ financing round. This marks another vote of confidence from investors, following the Series A round led by SDIC Innovation Investment in September 2021. The combined total of these two financing rounds amounts to hundreds of millions of RMB.

The Series A+ financing round saw participation from Hongfu Asset and Industrial Bank Guoxin Asset Management, with China Renaissance serving as the exclusive financial advisor for the transaction.This round of funding will be used to advance the clinical development of multiple global innovative drugs with tumor microenvironment-specific activation capabilities, accelerate the research and development of the company’s technology platform and early-stage pipeline, and address the substantial unmet clinical needs in oncology.

AFFINITY is a clinical-stage biopharmaceutical company dedicated to the global development of innovative anti-cancer drugs. It possesses globally first-in-class patented chemical conjugation technology and exclusive conjugation linkers, which can upgrade traditional drugs into novel, precision-guided therapeutics designed for delivery and activation within the tumor microenvironment. By utilizing microenvironment-activatable chemical groups and linkers to mask drug activity, AFFINITY achieves peripheral toxicity containment while enabling specific activation within tumor tissues. This approach addresses on-target toxicity, enhances therapeutic efficacy, and broadens the safety window.

AFFINITY’s unique platform technology brings new hope for the upgrading and iteration of various anti-tumor drugs. The company has established a strategic layout across six major areas: small molecule-drug conjugates (SMDCs), antibody-drug conjugates (ADCs), antibody-cytokine fusion conjugates, microenvironment-activated cytokine conjugates, microenvironment-activated antibody conjugates, and microenvironment-activated bispecific antibody conjugates. This platform enables the enhancement of efficacy and reduction of toxicity for small molecules, cytokines, antibodies, bispecific antibodies, or multispecific antibodies through molecular structural modifications, resulting in novel molecules with global patent protection. All products in the company’s R&D pipeline are first-in-class and best-in-class innovative drugs with global rights, offering broad commercial prospects. Currently, the company’s small molecule conjugate drug, Legubicin, has initiated registrational clinical studies. Multiple other drug candidates, including Legushanol, have entered or are about to enter clinical development stages. These include self-developed and collaboratively developed antibody-cytokine fusion conjugates, microenvironment-activated antibody conjugates, and microenvironment-activated bispecific antibody conjugates.

Leveraging its robust platform extensibility, AFFINITY is actively pursuing collaborative development models, partnering with global pharmaceutical companies to create best-in-class innovative drugs. Currently, novel large-molecule therapeutics co-developed with innovative biopharmaceutical firms such as I-Mab have demonstrated superior efficacy in animal models and have entered the preclinical process development stage. In the future, chemotherapy and immunotherapy agents specifically activated within the tumor microenvironment will be integrated into various multi-drug combination anticancer regimens due to their low toxicity. AFFINITY will also actively engage in clinical collaborations with global pharmaceutical partners on combination therapies, developing novel therapeutic combinations to cure cancer and benefit patients worldwide.

Dr. Liu Chen, Founder, President, and Chief Strategy Officer of AFFINITY“The current round of financing further demonstrates investors’ strong recognition and confidence in our tumor microenvironment-specifically activated intelligent drug platform and our existing product pipeline. We focus on enhancing efficacy and reducing toxicity for molecules with potentially effective target mechanisms but significant toxicity, aiming to address the substantial unmet clinical needs in oncology. Our approach opens new avenues for expanding the clinical application of traditional drugs, developing novel molecular entities, and advancing combination therapies. Notably, the pan-cancer-specific protease targets we leverage are highly expressed in tumor tissues and exhibit broad-spectrum applicability, offering the potential to overcome target dependency and facilitate drug development across multiple solid tumors. We anticipate that, over the next 10 to 20 years, our technology platform will revolutionize cancer treatment, transforming malignant tumors into chronic, manageable conditions compatible with long-term survival.”

Dr. Liu Yuan, CTO of AFFINITYAFFINITY stated: “The two new strategic avenues pioneered by AFFINITY—‘non-toxic chemotherapy’ and ‘super antibodies’—require the participation of capital investors and partner pharmaceutical companies. We extend our gratitude to SDIC Venture Capital, Hongfu Asset Management, and Industrial Bank Guoxin Asset Management for their support of AFFINITY’s innovative technology development.”

AFFINITY’s “non-toxic chemotherapy” products, Lagubicin and Lagutexel, have entered the clinical stage. Traditional monotherapy chemotherapy typically employs doses close to the maximum tolerated dose; its severe and cumulative toxic side effects often lead patients to refuse or discontinue treatment. AFFINITY’s Lagubicin and Lagutexel neutralize the cytotoxicity of doxorubicin and paclitaxel, respectively. Clinical trials of Lagubicin have fully demonstrated its non-toxic profile toward blood cells, immune cells, and normal tissues, thereby overcoming the dosage and cumulative dose limitations associated with control drugs. This “non-toxic chemotherapy” retains the direct tumor-killing and inhibitory effects of first-line chemotherapeutic agents while enabling long-term combination with immunotherapy, achieving sustained tumor suppression without compromising patients’ quality of life.

Currently, two popular tracks dominate the iterative development of monoclonal antibody drugs. One is the bispecific/multispecific antibody track, which involves fusing antibodies to create bispecific or multispecific antibodies, as well as conjugating peptides and cytokines to antibodies to form novel molecular structures. The other track is the Antibody-Drug Conjugate (ADC) strategy, which involves conjugating cytotoxic drugs to antibodies. In this approach, the antibody primarily serves to enhance the targeting specificity of the cytotoxic agent, ultimately relying on the cytotoxic drug to kill tumor cells.AFFINITY is pioneering a new strategy distinct from these two approaches. It employs small chemical molecules to conjugate and block the binding sites of monoclonal or multispecific antibodies, including one or more binding regions of fused antibodies, thereby creating a novel class of macro-molecule/small-molecule hybrid structures. These engineered antibodies are termed “Super Antibodies.” This new generation of antibodies features both reduced toxicity and enhanced efficacy: by blocking antibody binding in circulation, it minimizes adverse effects while extending half-life; upon reaching the tumor microenvironment, the antibody’s function is restored, thereby enhancing therapeutic efficacy. Several “Super Antibodies” independently developed by AFFINITY are scheduled to enter clinical trials by the end of this year and in 2023, respectively, demonstrating their dual characteristics of enhanced efficacy and reduced toxicity. Currently, there is limited global competition in the development of second-generation antibodies via chemical conjugation modification similar to AFFINITY’s approach. Therefore, the company hopes to attract more capital and collaborative pharmaceutical enterprises to participate in the research and development of “Super Antibodies.”

SDIC Venture CapitalAFFINITY stated: “Our proprietary tumor microenvironment-targeted activation technology provides a reliable means to direct small-molecule drugs, conventional chemotherapeutics, high-potency cytokines, and antibodies specifically to the tumor microenvironment. This approach is expected to significantly widen the therapeutic window of these agents and holds broad application potential. The metabolic and efficacy data from the Phase I clinical readout of our first-in-class product have validated the design principles of this technology platform. As our pivotal Phase II/III trials advance, along with the clinical development of subsequent pipeline candidates, we have every reason to anticipate even more encouraging clinical results.”

Dr. Yang Zhichun, Partner at Hongfu Asset Management“Hongfu Asset focuses on frontier technological innovation, prioritizing investments in sci-tech innovative enterprises that align with national strategies, achieve breakthroughs in key technologies, and enhance the country’s core competitiveness. AFFINITY’s R&D team has leveraged its extensive expertise to develop a globally leading platform for tumor microenvironment-specific activation. Based on this platform technology, the company has built a robust product pipeline covering both small molecules and biologics, and has entered into multiple product development collaborations with industry peers. Currently, AFFINITY’s most advanced candidate has initiated registrational clinical trials, with preliminary human data strongly validating the unique mechanism of action of this platform technology. We are honored to participate in this round of financing for AFFINITY and look forward to the early market launch of its products to benefit a broad patient population.”

Li Wei, Head of Equity Investment Department I, Xingye Guoxin Asset Management“AFFINITY is a platform-driven biotech company with distinct characteristics. Its core team boasts over 20 years of expertise and accumulation in the field of tumor microenvironment-activating therapeutics. The company’s platform is applicable to both small-molecule and large-molecule drugs. Preclinical and clinical data demonstrate that AFFINITY’s platform and products hold significant value for clinical development. Industrial Securities Cinda Asset Management is honored to participate in this round of financing for AFFINITY and looks forward to seeing its products benefit more cancer patients at an early date.”

Xie Yijing, Managing Director and Head of the Healthcare & Life Sciences Group at China Renaissance“We are honored to have assisted AFFINITY in closing this round of financing. Systemic toxicity has long been a major bottleneck limiting the clinical application of anti-tumor drugs. AFFINITY’s tumor microenvironment-specific activation platform offers a novel mechanism that brings fresh breakthroughs to anti-tumor drug development. We sincerely hope that the company can leverage this financing to accelerate the clinical translation of this innovative technology, ushering in a new era of cancer therapy.”