Pfizer to Acquire Trillium Therapeutics for $2.26 Billion; Akeso Submits BLA for PD-1/CTLA-4 Bispecific Antibody Cadonilimab

【August 24, 2021 / Medical & Pharmaceutical News Digest】National centralized procurement for high-value artificial joint consumables will be launched on September 14; Liaoning Province revises staffing requirements for licensed pharmacists; Pfizer to acquire Trillium for $2.26 billion……Daily Latest Pharma & Medical News: Quick Reads for Your Continued Attention!

Part 1: Policy Brief

National Centralized Procurement for High-Value Medical Consumables (Artificial Joints) Will Commence on September 14

On the 23rd, the National Joint Procurement Office for High-Value Medical Consumables issued the "State-Organized Centralized Volume-Based Procurement Document for Artificial Joints (No. 2)". According to the document, the national centralized volume-based procurement for artificial joint products will commence in Tianjin on September 14. The products covered in this centralized volume-based procurement include prostheses for primary total hip replacement and prostheses for primary total knee replacement. The total intended procurement volume for hip joint product systems in the first year is 305,542 units, while that for knee joint product systems is 231,976 units. The volume-based procurement cycle will last for two years. (National Joint Procurement Office for High-Value Medical Consumables)

Changes to Licensed Pharmacist Staffing Requirements in Liaoning Province

On the 23rd, the Liaoning Provincial Medical Products Administration issued the 《Notice on Further Regulating the Staffing and Use of Licensed Pharmacists in Pharmaceutical Retail Enterprises (Draft for Comments)》. According to the draft, in rural and township areas with a significant shortage of licensed pharmacists, where pharmaceutical retail enterprises selling prescription drugs and Class A non-prescription drugs genuinely face difficulties in staffing licensed pharmacists, they are permitted to employ other pharmaceutical technical personnel to assume the responsibilities of licensed pharmacists, with a transition period ending on December 31, 2024. For enterprises that have already staffed licensed pharmacists in accordance with national requirements, substitution with other pharmaceutical technical personnel is prohibited. (Liaoning Provincial Medical Products Administration)

NMPA Revises Package Inserts for Oxaliplatin and Propylthiouracil Preparations

On the 24th, the NMPA issued the 《Announcement of the National Medical Products Administration on Revising the Package Inserts of Oxaliplatin Preparations (No. 102 of 2021)》 and the 《Announcement of the National Medical Products Administration on Revising the Package Inserts of Propylthiouracil Preparations (No. 103 of 2021)》, uniformly revising the content of the package inserts for oxaliplatin preparations (including Oxaliplatin for Injection, Oxaliplatin Injection, and Oxaliplatin Mannitol Injection) and propylthiouracil preparations (including Propylthiouracil Tablets, Propylthiouracil Enteric-Coated Tablets, and Propylthiouracil Enteric-Coated Capsules). The revisions include: uniformly adding a boxed warning, adding new adverse reactions, etc. (Company Announcement)

Part 2: Industry & Economy Insights

Kelun Pharmaceutical: Subsidiary Chuanning Biology's ChiNext Listing Application Accepted by Shenzhen Stock Exchange

On the 24th, Kelun Pharmaceutical announced that the application for its holding subsidiary Chuanning Biotech's initial public offering (IPO) and listing on the ChiNext board has been accepted by the Shenzhen Stock Exchange. (Corporate Announcement)

# Ocumension Therapeutics Acquires All Rights to Two Novartis Ophthalmic Products in Mainland China

On the 24th, Ocumension Therapeutics announced that its wholly-owned subsidiary, Ocumension (Hong Kong), has entered into an asset purchase agreement with Novartis, under which it will pay USD 35 million to acquire all rights and interests in mainland China for the two ophthalmic drugs Elestat and Betoptic, along with the transfer of their corresponding manufacturing technologies. (Corporate Announcement)

Pfizer Acquires Trillium for $2.26 Billion

On the 24th, Pfizer and Trillium Therapeutics announced that they have reached an agreement under which Pfizer will acquire Trillium Therapeutics, an oncology immunotherapy developer. Under the terms of the agreement, Pfizer will acquire all outstanding shares of Trillium Therapeutics for $2.26 billion, securing its two investigational therapies that block the CD47-SIRPα signaling pathway. (WuXi AppTec)

Two GlaxoSmithKline Executives Step Down

On the 23rd, GSK China announced personnel changes involving two senior executives: Wang Xinguang, Vice President of GSK and Head of Corporate Communications and Government Affairs in China, has decided to retire from the company; Chen Ming, Vice President of GSK and Head of Regulatory Affairs, has decided to leave the company to pursue external career opportunities. (Pharma Representative)

# Genevant Sciences and Takeda Announce Collaboration

On the 23rd, Genevant Sciences and Takeda announced a global collaboration and license agreement to leverage Genevant’s proprietary lipid nanoparticle technology platform to develop novel non-viral vector gene therapies for the treatment of rare liver diseases. (WuXi AppTec)

Enliven Therapeutics Secures $27 Million in Funding

On the 23rd, Anli Xirong announced the completion of a $27 million Series A-1 financing round. The funding will be used to advance two candidate therapies into Phase I clinical trials and to progress three immuno-oncology products to the IND application stage. (WuXi AppTec)

Salubris: Plans to Terminate "nanatinostat" Exclusive License Agreement

On the 24th, Shenzhen Salubris Pharmaceuticals Co., Ltd. announced that the Company intends to enter into a Termination Agreement with Viracta Subsidiary, Inc. regarding the exclusive licensing rights for "nanatinostat" in mainland China. Both parties shall cease to perform their rights and obligations under the *Exclusive License Agreement*, and VIRACTA will pay the Company USD 4 million. (Corporate Announcement)

Chongqing Pharmaceutical Holdings Interim Report: H1 Net Profit Reaches RMB 438 Million, Up 46.07% YoY

On the 24th, Chongqing Pharmaceutical Holdings Co., Ltd. released its interim report, with operating revenue for the first half of the year reaching RMB 30.111 billion, a year-on-year increase of 76.45%; net profit at RMB 438 million, up 46.07% year-on-year; and basic earnings per share of RMB 0.25. (Company Announcement)

Dirui Medical Semi-Annual Report: H1 Net Profit Reaches RMB 110 Million, Up 1.65% Year-on-Year

On the 24th, Dirui Medical released its semi-annual report, reporting first-half operating revenue of RMB 418 million, a year-on-year decrease of 9.82%; net profit of RMB 110 million, a year-on-year increase of 1.65%; and basic earnings per share of RMB 0.3978. (Corporate Announcement)

WuXi Biologics Interim Report: Net Profit RMB 1.883 Billion, Gross Profit Increases by 191.7%

On the 24th, WuXi Biologics announced its first-half financial results. Revenue for the first half reached RMB 4.4068 billion, up 126.7% year-on-year; gross profit stood at RMB 2.2968 billion, up 191.7% year-on-year; net profit reached RMB 1.883 billion, up 157.7% year-on-year, thereby exceeding performance targets. (Company Announcement)

Tonghua Dongbao's H1 Operating Revenue Reaches Approximately RMB 1.662 Billion, Up 12.71% Year-on-Year

On the 24th, Tonghua Dongbao disclosed its 2021 semi-annual report, which showed that operating revenue for the first half of 2021 was approximately RMB 1.662 billion, a year-on-year increase of 12.71%; net profit attributable to shareholders of the listed company was approximately RMB 674 million, up 24.47% year-on-year. (Company Announcement)

Allist: Furmonertinib Commercially Launched, H1 Revenue Surges 37,212%

On the 24th, Allist Pharmaceuticals announced its 2021 semi-annual report, reporting first-half operating revenue of RMB 121 million, a year-on-year increase of 37,211.85%; net loss stood at RMB 78.3418 million, compared to a net loss of RMB 134 million in the same period last year. The company's Class 1 innovative drug furmonertinib for the treatment of non-small cell lung cancer (NSCLC) has been officially approved and launched for commercial sale, driving substantial increases in both operating revenue and gross profit. (Company Announcement)

CARsgen Therapeutics Interim Report: Two CAR-T Products Secure Overseas Licensing

On the 23rd, Carsgen Therapeutics released its interim results for the first half of 2021. According to the report, its BCMA-targeted CAR-T product, CT053, has entered Phase II clinical trials in the United States. The company plans to submit marketing authorization applications to the NMPA and the FDA in the first half of 2022 and the first half of 2023, respectively. Additionally, in July 2021, Carsgen Therapeutics completed the out-licensing of two CAR-T candidate products. (Company Announcement)

CARsgen Therapeutics Interim Report: Two CAR-T Products Secure Overseas Licensing Deals

On the 24th, North China Pharmaceutical Group Co., Ltd. announced that its net profit for the first half of the year was 1.005 million yuan, down 99.16% year-on-year; after deducting non-recurring gains and losses, it incurred a loss of 30.007 million yuan, compared to an adjusted net profit excluding non-recurring items of 9.817 million yuan in the same period last year. (Corporate Announcement)

Part 3: Pharma & Medical News

Alphamab Oncology Licenses China Rights of HER2 Bispecific Antibody to CSPC Pharmaceutical Group

On the 23rd, CSPC Pharmaceutical Group and Alphamab Oncology jointly announced that the two companies have entered into a licensing agreement regarding Alphamab Oncology’s independently developed HER2 bispecific antibody. Under the terms of the agreement, CSPC’s subsidiary, Jinment Biotechnology, will acquire the exclusive license to develop and commercialize KN026 as a monotherapy and in combination with KN046 for breast cancer and gastric cancer indications in mainland China. The subsidiary will bear all costs and expenses associated with clinical development activities and will become the Marketing Authorization Holder (MAH) for KN026 in mainland China. (Insight Database)

Pfizer Announces Positive Data from Phase 2 Clinical Trial of Talazoparib in Advanced Prostate Cancer

The latest Phase II TALAPRO-1 clinical trial of Pfizer’s BRCA-targeted drug talazoparib demonstrates that it can slow tumor growth in patients with advanced prostate cancer. Among evaluable patients assessed at baseline and post-baseline, 80% showed a reduction in tumor burden, 72% exhibited decreased PSA levels, and 82% had a reduced circulating tumor cell (CTC) count. Regarding safety, the most frequently reported Grade 3/4 treatment-emergent adverse events (TEAEs) were anemia (31%), thrombocytopenia (9%), and neutropenia (8%). No treatment-related deaths were reported. (Sina Medical News)

FDA Approves Korsuva for Moderate-to-Severe Pruritus in Patients with Chronic Kidney Disease

On the 24th, Cara Therapeutics and Vifor Pharma jointly announced that the FDA has approved Korsuva for the treatment of moderate-to-severe pruritus in adult patients with chronic kidney disease undergoing dialysis. (WuXi AppTec)

Akeso Files for Marketing Approval of PD-1/CTLA-4 Bispecific Antibody and Receives Priority Review Designation

On the 23rd, Akeso, Inc. announced that it has received CDE consent to submit a new drug application (NDA) for cadonilimab (a PD-1/CTLA-4 bispecific antibody, development code: AK104), a novel cancer immunotherapy drug for the treatment of recurrent or metastatic cervical cancer, and has been granted priority review designation. (Insight database)

World's First mRNA COVID-19 Vaccine Receives Full FDA Approval

On the 23rd, BioNTech SE announced that the FDA approved the Biologics License Application (BLA) for COMIRNATY® (an mRNA COVID-19 vaccine) for use in individuals aged 16 years and older to prevent SARS-CoV-2 infection. This is the first COVID-19 vaccine to receive full approval from the FDA, and the first globally approved COVID-19 vaccine with complete Phase 3 clinical data. (Sina Medical News)

CTLA-4 Fusion Protein Receives FDA Priority Review Designation

On the 23rd, Bristol Myers Squibb announced that the FDA has granted Priority Review to its supplemental Biologics License Application (sBLA) for the immunomodulator Orencia, for the prevention of moderate to severe acute graft-versus-host disease in patients aged 6 years and older undergoing unrelated donor hematopoietic stem cell transplantation. (WuXi AppTec)

Boan Biotech's Bevacizumab Injection Approved for Hepatocellular Carcinoma Indication

On the 23rd, Luye Pharma announced that its controlled subsidiary Boan Biotech's Bevacizumab Injection, an anti-tumor biologic drug, has been approved by the NMPA for the treatment of hepatocellular carcinoma. (PR Newswire)

Eli Lilly Submits Ramucirumab for Marketing Approval for New Indication

On the 23rd, the CDE official website shows that Eli Lilly has filed for marketing approval for a new indication of ramucirumab. Ramucirumab is currently approved for five indications: gastric cancer, non-small cell lung cancer, colorectal cancer, hepatocellular carcinoma, and advanced/metastatic non-small cell lung cancer with EGFR mutations. The indication submitted for approval this time is speculated to be second-line hepatocellular carcinoma. (CDE)

Tianyao's Isoniazid Injection Passes Generic Drug Consistency Evaluation

On the 24th, Tianyao Pharmaceuticals announced that its subsidiary, Jinyao Pharmaceutical, recently received the "Notice of Approval for Supplementary Drug Application" approved and issued by the NMPA for Isoniazid Injection, approving the drug to pass the consistency evaluation of quality and efficacy of generic drugs. Isoniazid Injection is an antitubercular agent used in combination with other antituberculosis drugs for the treatment of various types of tuberculosis and certain non-tuberculous mycobacterial diseases. (Company Announcement)

MaiPu Medical's Application for Medical Device Registration Certificate Has Been Approved

On the 24th, Medprin announced that, based on information recently released on the NMPA Government Service Portal System, the Class III Medical Device Registration Certificate for its absorbable oxidized regenerated cellulose product has been approved. Scope of application: In intracranial surgery, when ligation or other conventional hemostatic methods are inoperable or ineffective, the product is used as an adjunct hemostatic agent to control oozing from capillaries, veins, and small arteries. (Company Announcement)

Staidson's BDB-001 Injection Approved for New Drug Clinical Trial

On the 24th, Staidson Biopharma announced that it and its wholly-owned subsidiary Defengrui recently received the 《Notice of Approval for Drug Clinical Trial》 issued by the NMPA for BDB-001 Injection for the indication of treating ANCA-associated vasculitis, approving the conduct of clinical trials of this product in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. （Company Announcement）

Antengene's Selinexor Phase II Clinical Trial Application Approved in China

On the 23rd, Antengene announced that the NMPA approved a Phase II clinical trial in China to evaluate selinexor for the treatment of patients with myelofibrosis. (WuXi AppTec)

Yiling Pharmaceutical's Wholly-Owned Subsidiary Passes Drug GMP Compliance Inspection

On the 24th, Yiling Pharmaceutical announced that its wholly-owned subsidiary, Hengshui Yiling, recently successfully passed the GMP compliance inspection for pharmaceutical production organized by the Hebei Provincial Medical Products Administration, and received the 《Notice of Drug GMP Compliance Inspection Results》 approved and issued by the Hebei Provincial Medical Products Administration. (Company Announcement)

Gilead's Novel Capsid Function Inhibitor Under Review in the US and EU

Gilead Sciences recently announced that the European Medicines Agency has accepted the marketing authorization application for lenacapavir, a long-acting HIV-1 capsid inhibitor. The proposed indication is for use in combination with other antiretroviral drugs for the treatment of adults with multidrug-resistant HIV-1 infection who are currently on a failing ARV regimen due to resistance, intolerance, or safety considerations. (BioValley)