▲October 26-27, Chengdu
China Clinical Trials Industry Development ConferenceFree Registration
Note:This article does not constitute any investment opinions or recommendations., subject to official/company announcements;This article only provides an introduction to drugs related to medical health, not a recommendation for treatment plans (if involved), and does not represent the platform's position.Reproduction of any article requires authorization.
The Going Global of Chinese Pharmaceutical Companies: An Important Trend in the Current Pharmaceutical IndustryAccording to incomplete statistics, from January 2024 to presentAt least 21 casesOutbound Licensing Events of Chinese Pharmaceutical Companies (Due to the positioning of the official account, small molecule drugs were not counted.）。In terms of product categories: there are 6 ADC products, 7 monoclonal antibody products, 5 bispecific antibody products, 4 GLP-1 products, 2 RNAi products, 1 vaccine product, and 1 radiopharmaceutical product. Foreign pharmaceutical companies remain highly enthusiastic about "tapping into" China-produced ADCs.From the perspective of enterprises:Those with a higher number of overseas transactions are:Biocytogen (3 times), Bio-Thera (2 times), and MediLink (2 times).In terms of transaction value: the total value of 21 overseas transactions exceeded 16.2 billion US dollars. The transaction with the highest amount wasBowang Pharmaceutical, with$4.165 billion willMultiple RNAi Therapies Licensed to Novartis; In Addition,Seven deals with a total value exceeding $1 billion.
Puzhong Discovery & ADCendoOn August 20, 2024, Puzhong Discovery and Adcendo jointly announced that they had entered into a licensing agreement for a novel, highly differentiated antibody-drug conjugate (ADC) targeting tissue factor (Anti-TF), code-named ADCE-T02 (Puzhong Discovery's research and development code: AMT-754). Adcendo will obtain exclusive global development and commercialization rights outside of Greater China, while Puzhong Discovery will retain the development and commercialization rights in the Greater China region (including mainland China, the Hong Kong Special Administrative Region, the Macao Special Administrative Region, and Taiwan).
According to the financial terms of the agreement, Puzhong Discovery will receive tens of millions of dollars as an upfront payment and is eligible for additional payments upon achieving subsequent development, regulatory, and commercial milestones.Total milestone payments exceeding 1 billion US dollars will be collected., as well as single-digit to low double-digit percentage royalties based on net sales worldwide (excluding Greater China).ADCE-T02 is a novel, highly differentiated Anti-TF ADC. Its unique antibody design can reduce the impact on the coagulation pathway. Meanwhile, the T1000-exatecan linker-payload technology platform has been proven to amplify the "bystander effect," enhance linker stability, and possess the potential to overcome drug resistance mechanisms. These differentiated characteristics are expected to translate into higher clinical response rates, longer duration of efficacy, and better safety, offering a superior therapeutic window.ADCE-T02 has been submitted for clinical trials in Australia and is expected to file for U.S. IND in the near future.On August 1, 2024, Yiming Angke Biomedical Technology (Shanghai) Co., Ltd. and Instil Bio, Inc. announced an agreement whereby Instil Bio will obtain the development and commercialization rights outside of Greater China for Yiming Angke's proprietary PD-L1xVEGF bispecific antibody IMM2510 and next-generation CTLA-4 antibody IMM27M.Under the terms of the agreement, Instil Bio's wholly-owned subsidiary (SynBioTx) will obtain global development and commercialization rights for IMM2510 and IMM27M outside of Greater China, while Yiming Angke Biomedical Technology (Shanghai) Co., Ltd. will retain development and commercialization rights in Greater China (including Taiwan, Macao, and Hong Kong). Yiming Angke will receive an upfront payment of up to US$50 million and potential near-term payments. Upon achieving certain development, regulatory, and commercial milestones, the company is expected to receive milestone payments totaling over US$2 billion, as well as tiered royalties in the single-digit to low double-digit percentage range based on net sales worldwide (excluding Greater China).IMM2510 is a novel, potentially best-in-class PD-L1xVEGF bispecific antibody composed of an anti-PD-L1 antibody fused to a vascular endothelial growth factor (VEGF) receptor that binds VEGF. IMM2510 has completed a dose-escalation clinical trial for advanced solid tumors and demonstrated multiple efficacy events, including in patients with squamous non-small cell lung cancer (NSCLC) who failed prior PD-1 inhibitor treatment.IMM27M is a next-generation CTLA-4 antibody with enhanced ADCC activity, designed to promote intratumoral regulatory T cell depletion to improve the efficacy and reduce the toxicity of first-generation CTLA-4 antibodies. IMM27M has completed a dose-escalation clinical trial, demonstrating anti-tumor activity in patients with advanced solid tumors, and entered a combination study with IMM2510 in China in July 2024.Full-Life Technologies & SK BiopharmaceuticalsOn July 17, 2024, Full-Life Technologies, a radiopharmaceuticals company, announced that it had entered into an out-licensing agreement with SK Biopharmaceuticals, a biotechnology company. Under the agreement, Full-Life Technologies granted SK Biopharmaceuticals exclusive global rights to conduct clinical research, development, manufacturing, and commercialization of the radiopharmaceutical FL-091 for cancers positive for neurotensin receptor 1 (NTSR1).
FL-091 is a small molecule radioligand carrier designed to precisely deliver radiopharmaceuticals to cancer cells by specifically binding to NTSR1.NTSR1 is a receptor protein that is selectively highly expressed in a variety of solid tumors, including colorectal cancer and pancreatic cancer.
The total amount of the transaction is 571.5 million US dollars., including upfront payment, R&D and commercial milestone payments, with royalties not included. SK Biopharmaceuticals will introduce the radiopharmaceutical drug conjugate (RDC) project FL-091 targeting NTSR1 and its backup compounds, aiming to develop it into an innovative anti-cancer drug. SK Biopharmaceuticals also holds the right of first negotiation for other pre-selected RDC projects from Full-Life Technologies.
On July 11, 2024, Ipsen and Foreseen Biotechnology announced an exclusive global licensing agreement for FS001, an ADC drug for cancer treatment. Foreseen Biotechnology will receive up to $1.03 billion, including upfront payments and significant milestone payments for development, regulatory, and commercialization achievements. Under the terms of the agreement, Ipsen will be responsible for Phase I clinical trial preparation activities, including IND submission, as well as all subsequent clinical development, manufacturing, and global commercialization activities.
FS001 is an ADC drug with FIC potential, targeting a novel tumor-associated antigen that is overexpressed in many solid tumors and plays a key role in tumor proliferation and metastasis.The addition of FS001 marks Ipsen's acquisition of its second licensed ADC, further enriching Ipsen's ADC pipeline portfolio.Ipsen Senior Vice President and Head of Early Development, Mary Jane Hinrichs, stated that a Phase I clinical trial is planned to evaluate FS001 in selected solid tumor types, hoping to provide critical new therapies for cancer patients worldwide.On July 9, Kang Nuoya Biomedical Technology (Chengdu) Co., Ltd., a wholly-owned subsidiary of Connoyma, entered into a licensing agreement with Belenos Biosciences, Inc.According to the license agreement, Kang Nuoya Biomedical Technology (Chengdu) Co., Ltd. granted Belenos Biosciences, Inc. exclusive rights to develop, manufacture, and commercialize the group’s candidate drugs CM512 and CM536 (research, development, registration, production, and commercialization) globally (excluding Greater China). Both CM512 and CM536 are bispecific antibodies independently developed by Kang Nuoya.
As consideration, Kang Nuoya Biomedical Technology (Chengdu) Co., Ltd. will receive an upfront payment and near-term payment totaling $15 million, while Yiqiao Hong Kong Holding Limited will acquire approximately 30.01% of Belenos Biosciences, Inc.'s equity. Upon achieving certain development, regulatory, and commercial milestones, Kang Nuoya Biomedical Technology (Chengdu) Co., Ltd. is also eligible to receive up to $170 million in additional payments. Following the first commercial sales of CM512 and CM536, Kang Nuoya Biomedical Technology (Chengdu) Co., Ltd. will also be entitled to receive tiered royalties on net sales from Belenos Biosciences, Inc. during a specified period. Unless otherwise agreed, Belenos Biosciences, Inc. will bear all costs associated with the development, regulatory, and commercialization activities for CM512 and CM536 within the licensed territory.In terms of the licensing agreement, Belenos and Kang Nuoya Biomedical Technology (Chengdu) Co., Ltd. will enter into a supply agreement, under which Belenos will have the right to purchase the required quantities of CM512 and CM536 from Kang Nuoya Biomedical Technology (Chengdu) Co., Ltd. or its contract manufacturers for the purpose of conducting these clinical trials.CM512 filed an IND application in May this year, and CM536 is in the preclinical stage.Mabcare Therapeutics & Day One BiopharmaceuticalsOn June 18, 2024, Day One Biopharmaceuticals, a Nasdaq-listed company in the United States, announced that it had entered into an exclusive licensing agreement with MabCare Therapeutics from Shanghai, China. Day One will hold the global exclusive rights to develop, manufacture, and commercialize MTX-13 outside of Greater China.
According to the terms of this agreement, MabCare Therapeutics received an upfront payment of $55 million (approximately 399 million RMB) and is eligible to receive up to an additional $1.152 billion in milestone payments related to development, regulatory registration, and commercialization, as well as single-digit royalties on net sales outside the Greater China region.
On June 13, Mingji Biotech andAbbVieJointly announce a licensing agreement for the development of FG-M701.FG-M701 is a next-generation TL1A antibody for the treatment of inflammatory bowel disease, currently in the preclinical development stage.
FG-M701 is a fully human monoclonal antibody targeting TL1A, a target that has been clinically validated in inflammatory bowel disease. Compared with the first-generation TL1A antibodies, FG-M701, through unique engineering modifications, aims to provide higher efficacy for the treatment of inflammatory bowel disease and reduce dosing frequency, demonstrating the potential to be a "best-in-class" therapy.
According to the terms of the agreement, AbbVie will obtain the exclusive global license for the development, production, and commercialization of FG-M701. Mingji Biotechnology will receive$150 millionThe upfront payment and near-term milestone payments, and is eligible for subsequent clinical development, regulatory registration, and commercialization milestone payments of up to 1.56 billion US dollars, as well as tiered royalties of up to a low double-digit percentage of net sales.
On June 3, 2024, Akeso announced that the company had signed a supplementary licensing agreement with Summit Therapeutics to expand the licensed market scope of Ivonescimab, a PD-1/VEGF bispecific antibody, under the original collaboration and licensing agreement between the two parties.According to the supplementary licensing agreement, Akeso will receive a $70 million upfront payment and milestone payments, as well as royalties from the sales of Ivonescimab in the newly licensed markets (the royalty rate remains consistent with the proportion specified in the cooperation agreement signed by both parties on December 5, 2022). Akeso will continue to supply Ivonescimab Injection for all licensed markets, including the newly licensed markets, and obtain supply revenue. Meanwhile, under the supplementary licensing agreement, both parties have further strengthened cross-regional sharing cooperation terms, including clinical trial data and regulatory submission documents, to accelerate the regulatory registration and commercialization of Ivonescimab across various global regions.Summit will obtain exclusive rights to the development and commercialization of Yivoki in the US, China, South America, the Middle East, and Africa. Meanwhile, Summit will continue to be responsible for clinical development, product registration, and commercialization in all licensed regions, including the newly added licensed markets, as well as all related expenses.On May 28, Bio-Thera announced that it had signed a licensing and commercialization agreement with STADA for BAT2506 (a golimumab biosimilar referencing Simponi). Under the terms of the agreement, Bio-Thera will be responsible for the research, development, manufacturing, and commercial supply of BAT2506, while STADA will oversee the commercialization of BAT2506 in the EU, UK, Switzerland, and other select European markets. Upon achieving corresponding milestone events, Bio-Thera is eligible to receive an upfront payment and milestone payments totaling up to $157.5 million, along with double-digit percentage royalties on net sales.
Golimumab is an antibody targeting TNF-α, which can specifically bind to both soluble and transmembrane human TNF-α with high affinity, blocking the binding of TNF-α to its receptor TNFR, thereby inhibiting the activity of TNF-α. The original product of golimumab has been approved globally for active psoriatic arthritis, moderately to severely active rheumatoid arthritis, active ankylosing spondylitis, and moderately to severely active ulcerative colitis.
BAT2506 is a golimumab biosimilar developed by Bio-Thera according to the relevant guidelines for biosimilars from China's NMPA, the U.S. FDA, and the European EMA. It has currently completed global Phase 3 clinical research. Its Phase 3 clinical study aims to compare the efficacy and safety of BAT2506 with the originator product golimumab in patients with psoriatic arthritis (PsA).
CStone Pharmaceuticals&EwopharmaOn May 27, CStone Pharmaceuticals announced that it had established a strategic commercialization partnership with European pharmaceutical company Ewopharma, granting Ewopharma the commercial rights to sugrelimab in Central and Eastern Europe.Under this licensing and commercialization agreement, Ewopharma will obtain the commercial rights to Sugemalimab in Switzerland and 18 Central and Eastern European (CEE) countries. This includes the EU member states of Bulgaria, Croatia, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, and Slovenia, as well as the non-EU countries of Albania, Bosnia and Herzegovina, Kosovo, North Macedonia, Moldova, Montenegro, and Serbia.CStone Pharmaceuticals will receive an upfront payment of up to US$51.3 million (equivalent to approximately RMB 370 million) as well as subsequent regulatory and sales milestone payments. CStone Pharmaceuticals will generate international revenue by selling products to Ewopharma AG, which will be responsible for pricing, reimbursement, marketing, distribution, and other related matters. CStone Pharmaceuticals will be responsible for supplying the products and providing necessary training and support for the associated brands.On May 27, MediLink and BioNTech granted an exclusive option and corresponding global exclusive license for the development of ADC products targeting a few specific cutting-edge innovative targets using MediLink's TMALIN® ADC technology platform.According to the terms of the new agreement, MediLink will receive an upfront payment of $25 million and is eligible to receive up to $1.8 billion in development, regulatory, and commercialization milestone payments, as well as tiered royalties based on future global annual net sales. As part of the agreement, MediLink will have the right of first negotiation for future out-licensing or transfer of these ADC products in any one or more regional markets within Greater China (Mainland China, Hong Kong, Macau, and Taiwan) by BioNTech.As early as October 2023, MediLink entered into a strategic collaboration and global licensing agreement with BioNTech for YL202/BNT326, an ADC project targeting HER3.Biocytogen & Gilead SciencesOn February 19, 2024, Biocytogen announced that it had entered into an antibody evaluation and selection agreement with Gilead Sciences. The agreement grants Gilead access to Biocytogen's fully human antibody library, which has been developed for a wide range of drug targets, to evaluate antibodies for relevant targets. During the three-year nomination period, Gilead will nominate multiple targets of interest, assess the corresponding antibodies, and has the option to select specific antibodies for the development of therapeutic products on a global scale.According to the agreement, Biocytogen will receive a payment that enables Gilead Sciences to evaluate specific antibodies targeting selected antigens. For each nominated antigen with a chosen antibody, Biocytogen is entitled to option exercise fees, development, regulatory, and sales milestone payments, as well as single-digit percentage royalties on net sales.On January 8, 2024, Biocytogen Pharmaceuticals (Beijing) Co., Ltd. announced an exclusive option and licensing agreement with Radiance Biopharma for an ADC product.
This agreement grants Radiance the right to opt for obtaining the license of a Biocytogen first-in-class fully human HER2/TROP2 bispecific antibody-drug conjugate (bispecific ADC) for the development, manufacturing, and commercialization of therapeutic products targeting any human diseases on a global scale. HER2 and TROP2 are two tumor-associated antigens (TAAs) that have been found to be co-expressed in various types of tumors, including breast cancer, gastric cancer, colorectal cancer, bladder cancer, pancreatic cancer, and non-small cell lung cancer.According to the agreement, if Radiance exercises the option, Biocytogen will be entitled to an option exercise fee, licensing fees, development and commercialization milestone payments, as well as single-digit percentage royalties on net sales. If Radiance sublicenses to a third party, Biocytogen will also be entitled to sublicense fees.In 2023, the number of License-out deals by Chinese pharmaceutical companies continued to grow, with deal sizes constantly reaching new highs. A total of 58 License-out events occurred throughout the year, surpassing the number of License-in projects for the first time.
As cutting-edge technologies continue to break through and the technological capabilities for new drug production and manufacturing keep improving, China's innovative drug research and development has shown an unprecedented level of activity. Multiple domestically produced innovative drugs have entered a harvest period of results, providing a solid product foundation for Chinese pharmaceutical companies to expand overseas.As Chinese pharmaceutical companies accelerate their expansion into overseas markets, their competitiveness in the international market will continue to grow. At the same time, these companies will place greater emphasis on international cooperation and mutual benefits, working with leading global enterprises to jointly advance the development of the global pharmaceutical industry.
References: Official websites of various companies
Copyright statement: This article is reproduced from Biopharma Era,Media or individuals who do not wish to be reprinted can contact us, and we will delete it immediately.
[About PharmaCircle]
PRHub of Yaorong Circle aims to assist biopharmaceutical technology enterprises in brand promotion and business development services. It provides systematic solutions based on clients' real needs, using "translation-simplification-contextualization" to convey clients' brand information in a straightforward and understandable manner to the public. With access to over 1 million vertical users across various channels, it achieves cooperation objectives while helping partners complete closed-loop marketing services from branding to business development. We have successfully organized dozens of offline biopharmaceutical R&D conferences with a scale of 1,000 attendees, covering areas such as small-molecule new drugs, large-molecule new drugs, improved new drugs, and cross-border BD transactions, serving more than a hundred listed/unicorn/biotech/pharmaceutical companies.
