Johnson & Johnson to Spin Off Orthopedics Business; I-Mab Plans Hong Kong IPO; CSPC, 3SBio Among Others Submit NDA Applications | Arterial Weekly Report

Li Jiaying Author: Interns Chen Chuan, Zheng Ao, He Duo

New Drug Development

AbbVie's RINVOQ® (upadacitinib) Receives FDA Approval for Supplemental New Drug Application to Treat Inflammatory Bowel Disease

On October 13, AbbVie's official website announced that the U.S. Food and Drug Administration (FDA) had approved its supplemental New Drug Application (sNDA) to update the indication statement for RINVOQ® (upadacitinib) in treating adult patients with moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn's disease (CD). Previously, RINVOQ was indicated for adult patients with moderately to severely active UC or CD who had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) inhibitors.

Roche Collaborates with Eli Lilly to Develop Elecsys, a Blood Test for Alzheimer's Disease, Approved by FDA for Market Launch

On October 13, Roche announced that the Elecsys pTau181 test, developed in collaboration with Eli Lilly and Company, received FDA approval for market launch. This is currently the only blood-based biomarker (BBM) test available to assist primary care institutions in the preliminary evaluation of Alzheimer's disease and other causes of cognitive decline. The Elecsys pTau181 test is suitable for patients aged 55 and above who exhibit signs, symptoms, or complaints of cognitive decline. The test measures phosphorylated Tau (pTau) 181 protein in human plasma, a key biomarker of Alzheimer's disease pathology, including amyloid plaque and tau aggregate pathology.

Novartis' Fabhalta® (iptacopan) Meets Primary Endpoint in Phase III Trial

On October 16, Novartis announced the final results of the Phase III clinical trial of Fabhalta® (iptacopan) for the treatment of adult IgA nephropathy (IgAN). Fabhalta is an oral complement bypass inhibitor that demonstrated statistically significant and clinically meaningful advantages in slowing the progression of IgAN compared to placebo, with good tolerability and safety consistent with previously reported data. Novartis plans to use these data to support the regulatory submission for Fabhalta's market approval in 2026. In addition to Fabhalta, Novartis plans to continue advancing its IgAN portfolio, including Vanrafia® (atrasentan) and the investigational compound zigakibart.

Financial Report Information

Johnson & Johnson Announces Q3 2025 Earnings Report

On October 14, Johnson & Johnson announced its financial report for the third quarter of 2025. Johnson & Johnson demonstrated strong performance in the third quarter, with global sales reaching $24 billion, representing a 5.4% increase compared to the same period last year. International sales grew by 4.4%, and net earnings amounted to $5.2 billion. In terms of business segments, the pharmaceuticals innovation division generated $15.563 billion in sales, marking a 6.8% year-over-year growth. Key revenue drivers included products such as DARZALEX and CARVYKTI in oncology, and TREMFYA in immunology. The medical technology business achieved total sales of $8.43 billion, reflecting a 6.8% year-over-year increase, with significant contributions from growth in product lines such as cardiovascular, general surgery, and surgical vision.

Business Changes

Johnson & Johnson Announces Plan to Spin Off Orthopedics Business

On October 14, Johnson & Johnson announced plans to spin off its orthopedics business into an independent company operating under the name DePuy Synthes within 18 to 24 months. The spin-off and the operations of the independent company will be led by Namal Nawana. Johnson & Johnson's orthopedics unit focuses on manufacturing products such as hip, knee, and shoulder implants and surgical instruments, generating approximately $9.2 billion in revenue last year, accounting for about 10% of the company’s total revenue.

Trends in Transactions and Financing

PRIGEN and Kite, a subsidiary of Gilead, reach a $1.64 billion collaboration

On October 16, Kite Pharma, a subsidiary of Gilead, further increased its investment in in vivo CAR-T therapy technology by signing a biopharmaceutical industry cooperation agreement worth up to $1.64 billion with Chinese biotech company Pregene Biopharma. According to the statement, Kite Pharma will make an upfront payment of $120 million to Pregene Biopharma for the joint development of next-generation in vivo therapies.

New Drug Progress

BeiGene's Sotorasib Granted FDA Breakthrough Therapy Designation

On October 13, BeiGene's official website announced that the FDA had granted Sotoclax (a next-generation investigational BCL2 inhibitor with best-in-class potential) Breakthrough Therapy Designation (BTD) for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). This decision was based on the data from the BGB-11417-201 study. BGB-11417-201 is a Phase 1/2 study evaluating the efficacy of Sotoclax in adult patients with R/R MCL who have previously received Bruton's tyrosine kinase inhibitor (BTKi) and anti-CD20 therapy.

CSPC's New Drug Application for Edeglyptin α Injection Accepted

On October 13, CSPC Pharmaceutical Group announced that the new drug marketing application for Exenatide α Injection, developed by its subsidiary CSPC BAIKE (Shandong) Biopharmaceutical Co., Ltd., has been accepted by the National Medical Products Administration of the People's Republic of China. The product is filed as a Class 1 new therapeutic biologic, and its indication is for long-term weight management in overweight or obese adults based on controlled diet and increased physical activity.

Betta Pharmaceuticals' Partner Launches DURAVYU Global Phase III Clinical Trial, Tackling Diabetic Eye Disease

On October 15, EyePoint, the strategic partner of Betta Pharmaceuticals, announced the official launch of two pivotal global Phase III clinical trials for its innovative drug DURAVYU™ in treating diabetic macular edema (DME). The trial is expected to complete the first patient dosing in the first quarter of 2026. DURAVYU™ is an implant that achieves sustained delivery of Vorolanib through a controlled-release technology. Recent studies have revealed that it not only blocks VEGF but also counters IL-6 mediated inflammation by inhibiting the JAK-1 target, featuring a dual mechanism of action.

This Phase III study will evaluate the efficacy of DURAVYU administered once every six months. If successful, DURAVYU is expected to become the first TKI-class drug to enter the ophthalmology market, offering a longer-lasting and comprehensive new treatment option for approximately 28 million DME patients worldwide.

3SBIOINC's Anti-VEGF Ophthalmic New Drug Marketing Application Accepted, Tackling Retinal Vein Occlusion

On October 15, 3SBIOINC announced that the marketing application for its self-developed recombinant anti-VEGF humanized monoclonal antibody (601A) for the treatment of macular edema caused by branch retinal vein occlusion (BRVO) has been accepted by the National Medical Products Administration. The drug met the primary endpoint in the Phase III clinical trial, showing non-inferiority to the control drug ranibizumab in terms of vision improvement after 24 weeks of treatment. Secondary endpoint data showed sustained improvement in patients' vision, significant reduction in macular edema, and overall good safety.

Junshi Biosciences Receives FDA Approval to Conduct Phase II/III Clinical Study of JS207 (PD-1/VEGF Bispecific Antibody) as Neoadjuvant Therapy for Non-Small Cell Lung Cancer

On October 16, Junshi Biosciences announced on its official website that the U.S. Food and Drug Administration (FDA) has recently approved the company to conduct an open-label, two-arm, randomized, positive-controlled Phase II/III study of JS207 (PD-1/VEGF bispecific antibody) compared with Nivolumab for neoadjuvant treatment in patients with resectable, driver gene alteration (AGA)-negative non-small cell lung cancer (NSCLC) at stage II/III.

This study is an open-label, two-arm, randomized, positive-controlled international multicenter Phase II/III trial, aiming to compare the efficacy and safety of JS207 with Nivolumab as neoadjuvant therapy for patients with Stage II/III, resectable, AGA-negative NSCLC. This research marks the first time a PD-1/VEGF dual-target drug has been approved to conduct a confirmatory study in a surgical patient population.

Kelun Botai's Budotuzumab Injection Approved for Marketing

On October 17, the NMPA official website announced that Kelun-Biotech's HER2 ADC "Boductuzumab" (trade name: Shutalei) has been approved for marketing. It is indicated for the treatment of adult patients with HER2-positive unresectable or metastatic breast cancer who have previously received at least one anti-HER2 therapy. In addition to breast cancer, Boductuzumab is also expanding into new indications, including gastric cancer, non-small cell lung cancer, and colorectal cancer.

Market Dynamics

Xuanzhu Biotech Lists on HKEX

On October 15, Xuanzhu Biotech officially listed on the Main Board of the Hong Kong Stock Exchange. Xuanzhu Biotech's IPO was priced at a fixed price of HK$11.6 per share, with the company’s market value calculated to be approximately HK$6.008 billion. Cornerstone investor Beijing Denorui Lang Fifteen subscribed for about HK$76.6 million.

Tianjing Biotechnology (Shanghai) Co., Ltd. Announces Plan to List on the Hong Kong Stock Exchange

On October 16, I-Mab announced that the company plans to conduct an initial public offering (IPO) in Hong Kong, achieving dual listing on Nasdaq in the United States and the Hong Kong Stock Exchange, and intends to change its name to NovaBridge Biosciences. The company also announced plans to acquire VIS-101, a novel bispecific biologic drug targeting VEGF-A/ANG2. This acquisition will be completed by its wholly-owned subsidiary Visara and is expected to be finalized this month. Additionally, Kyler Lei has been appointed as the Chief Financial Officer of I-Mab. The company will issue H shares in Hong Kong through a "dual listing" on Nasdaq and the Hong Kong Stock Exchange, with plans to change its English name to NovaBridge Biosciences.

Hansoh Pharma Grants Roche Exclusive License for Novel Targeted CDH17 Antibody-Drug Conjugate HS-20110

On October 17, HANSOH PHARMACEUTICAL announced that it had signed a licensing agreement with Roche for HS-20110. HS-20110 is a targeted CDH17 antibody-drug conjugate (ADC) using a clinically validated topoisomerase inhibitor (TOPOi) payload. HANSOH PHARMACEUTICAL has granted Roche exclusive rights to advance the development and commercialization of HS-20110 globally (excluding mainland China, Hong Kong, Macao, and Taiwan). According to the agreement, HANSOH PHARMACEUTICAL will receive an upfront payment of $80 million and is eligible to receive milestone payments based on the product’s development, regulatory approval, and commercialization progress, as well as tiered royalties on future potential product sales.

Transactions and Financing Trends

JACOBIO PHARMACEUTICALS AND HAISONG CAPITAL REACH STRATEGIC TRANSACTION

On October 16, JACOBIO PHARMACEUTICALS announced that its holding company, Beijing Jacobio New Drug Research and Development Co., Ltd., signed an investment increase and equity transfer agreement with Shanxi Haisong Management Consulting Partnership and an industry cooperator. According to the agreement, Haisong Capital will acquire 80% of Beijing Jacobi Rui Kang Pharmaceutical Technology Co., Ltd. ("Jacobi Rui Kang") for an upfront payment of 125 million yuan and a milestone payment of 75 million yuan. After the completion of the transaction, Beijing Jacobio, Haisong Capital, and the industry cooperator will hold 10%, 80%, and 10% of Jacobi Rui Kang's shares, respectively.

The announcement shows that Jacarecon is a company dedicated to the early-stage cardiovascular R&D projects of the group. This transaction will help Jacobio focus on the strategic layout of its core pipeline in innovative oncology drugs (including KRAS, iADC, and other directions), which will optimize resource allocation. The proceeds from the transaction will be mainly used for the R&D, production, and commercialization of the company's Pan-KRAS inhibitors and other innovative cancer therapies.

Hansoh Pharma Licenses CDH17 ADC to Roche

On October 17, Hansoh Pharma announced that it had licensed the global rights (excluding Greater China) for the CDH17 ADC new drug HS-20110 to Roche. Roche will pay an upfront payment of $80 million, up to $1.45 billion in milestone payments, and a certain percentage of sales royalties, with the total transaction amounting to as much as $1.53 billion. HS-20110 is currently in global Phase I clinical trials.

Aosaikang's VEGF/ANG2 Bispecific Antibody Licensing Agreement Reached

On October 17, Beijing Aosaikang Pharmaceutical Co., Ltd.'s holding subsidiary AskGene Pharma, Inc. ("AskGene Pharma") reached a licensing agreement with Visara, Inc. ("Visara"), under which AskGene Pharma granted Visara the rights to its self-owned intellectual property Class 1 innovative drug ASKG712 project in the licensed territory for compensation.

ASKG712 is a Class 1 innovative drug independently developed by AskGene Pharma with proprietary intellectual property rights, which can simultaneously target VEGF and ANG-2. While blocking the VEGF/VEGFR signaling pathway to control the formation of new blood vessels, it effectively inhibits ANG-2 signaling to improve vascular stability and reduce retinal inflammation. It is clinically used for treating macular diseases of the fundus and is currently in Phase IIa clinical trials in China.

Fosun Karry Receives Over 650 Million Yuan in Series A Financing

On October 17, Fosun Pharma announced a capital increase for its holding subsidiary, Fosun Karry. The Shenzhen Biomedical Industry Fund (Fosun Capital) plans to participate in the Series A financing of Fosun Karry (formerly Fosun Kite), intending to contribute a total of 600 million yuan in several tranches to subscribe for no more than a combined 524,437,452 yuan of Fosun Karry’s newly added registered capital.

The 14 co-investment participants, including the current directors and core management team of Fosun Karry, intend to contribute a total of RMB 3.525 million through the co-investment platform to subscribe for an aggregate of RMB 3.08107 million in new registered capital of Fosun Karry. The pre-money valuation of this co-investment (Fosun Karry's pre-money valuation of RMB 2.2 billion) is consistent with this round of capital increase. The proceeds from the Series A financing will be used for the operation and business development of Fosun Karry and/or its subsidiaries.

PersonIncidentMove

Gan & Lee Pharmaceuticals New AppointmentChief Medical Officer (CMO)

On October 14, Gan&Lee Pharmaceuticals officially announced the appointment of Dr. Jia Ting as Corporate Vice President & Chief Medical Officer. Dr. Jia Ting will be fully responsible for the clinical development and registration strategy formulation of the company's products under research in the European and American regions, and will lead cross-team collaborative management.

Transcenta Holding Announces the Appointment of Tyler Marciniak as Senior Vice President of Capital Markets, Investor Relations and Corporate Communications

On October 16, Transcenta Holding announced the appointment of Mr. Tyler Marciniak as the new Senior Vice President of Capital Markets, Investor Relations and Corporate Communications, reporting directly to Dr. David Shengxian Qian, Chairman and Chief Executive Officer.