Lilly Submits IL-2R Agonist for Clinical Trial in China; Hutchmed’s Avapritinib Approved for GIST

[March 31, 2021 / Pharmaceutical News Overview]Fujian Province to Open Bids for 40 Centralized Procurement Items on May 7; WuXi Biologics Proposes Establishing a Joint Venture with $120 Million Investment; Keytruda Receives Complete Response Letter from US FDA for Treatment of High-Risk Early-Stage Triple-Negative Breast Cancer; CStone Pharmaceuticals’ Precision Oncology Drug “Avapritinib” Approved…Daily Fresh Pharmaceutical and Medical News: Quick Reads on What Matters to You!

Part 1 Policy Brief

# Fujian: Bids for 40 Drug Varieties to Be Opened on May 7

On the 30th, the Fujian Provincial Healthcare Security Administration issued the “Fujian Province Pharmaceutical Centralized Volume-Based Procurement Document,” launching volume-based procurement for 40 drug products. The majority of these 40 products are injections, and the procurement volumes for many products in Group A are zero, while Group B features larger volumes and thus more intense competition. The selection rules differentiate between Group A and Group B for competitive bidding, with a single round of quotation. According to the document, the bid opening for this round of volume-based procurement in Fujian Province is scheduled for May 7. (Fujian Provincial Healthcare Security Administration)

Shandong Province Implements First Batch of “Group-Purchased” High-Value Medical Consumables

Starting from the 30th, the results of Shandong’s first centralized volume-based procurement of high-value medical consumables were implemented across the province. The five categories of high-value medical consumables included in this initial batch of centralized volume-based procurement in the province are: rapid-exchange dilation balloons for coronary intervention, primary artificial hip joint replacements, absorbable dural (spinal) membrane patches, single-use trocar cannulas, and dual-chamber cardiac pacemakers. The average price reduction for these five categories of high-value medical consumables was 66%, with the highest reduction reaching 95.6%. (Shandong Release)

Release of the Second Batch of Key Monitoring and Priority Concern Drug Lists

Recently, the Fujian Provincial Drug and Medical Device Joint Procurement Center and the Fujian Provincial Healthcare Security Fund Center issued the “Notice on Publishing the List of Key Monitored Drugs and Key Focus Drugs for the Second Batch,” with 10 drugs included in the key monitored drugs list and 59 drugs included in the key focus drugs list. (Fujian Provincial Drug and Medical Device Joint Procurement Center, etc.)

Part 2 Industry Observation

WuXi Biologics Plans to Establish Joint Venture with $120 Million Investment, Dedicated to R&D and Manufacturing of ADCs and Other Drugs

On the 30th, WuXi Biologics announced that the company plans to establish a joint venture, WuXi XDC (Cayman) Inc. (“WuXi XDC”), with STA Pharmaceutical, a subsidiary of WuXi AppTec. This transaction is subject to approval by, among others, the shareholders of WuXi AppTec. According to the announcement, WuXi XDC will engage in the contract development and manufacturing of antibody-drug conjugates (ADCs) and other bioconjugate therapeutics. WuXi Biologics and STA Pharmaceutical intend to inject capital of USD 120 million and USD 80 million into WuXi XDC, respectively. (Corporate Announcement)

$470.5 Million! 3SBio Secures Exclusive Greater China Rights to Anti-CD47 Monoclonal Antibody IMC-002

On the 30th, ImmuneOncia Therapeutics and 3D Medicines entered into an exclusive licensing agreement for the anti-CD47 monoclonal antibody IMC-002. Under the agreement, 3D Medicines obtained exclusive rights to develop, manufacture, and commercialize IMC-002 as a monotherapy or in combination regimens for oncology indications within the Greater China region (including mainland China, Hong Kong, Macau, and Taiwan). ImmuneOncia will retain rights to IMC-002 in other regions, including the United States, the European Union, and Japan. (Jike Yaowen)

Immune-Onc Raises $73 Million to Support Development of “First-in-Class” New Drug

Immune-Onc Therapeutics Recently Completes Approximately $73 Million in Series B1/B2 Financing; Funds to Be Primarily Used for Global Advancement and Expansion of Its Novel Drug Pipeline and Operations in the US and China. To Date, Immune-Onc’s Total Financing Has Exceeded $110 Million. (WuXi AppTec)

Ascletis Increases R&D Investment in Tumor Lipid Metabolism and Oral Checkpoint Inhibitors

Ascletis Pharma Announces Increased R&D Investment in Tumor Lipid Metabolism and Oral Checkpoint Inhibitors; Product Pipeline Primarily Includes Two Oral PD-L1 Inhibitors and Two Fatty Acid Synthase (FASN) Inhibitors. (Insight Database)

BridGene Partners with Takeda to Develop Small-Molecule Drugs Targeting “Undruggable” Targets

BridGene Biosciences Announces Strategic Research Collaboration and License Agreement with Takeda. Under this collaboration, the two parties will initiate up to five new drug discovery projects, leveraging BridGene’s proprietary IMTAC chemoproteomics platform to identify novel targets and small-molecule candidates for Takeda, which will advance these candidates into clinical development. (WuXi AppTec)

Part 3 Pharmaceutical News

Telomerase Modulators for Alzheimer’s Disease Treatment: Positive Phase 2 Clinical Results Released

GemVax & KAEL Announce Publication of Positive Phase 2 Clinical Trial Results of Investigational Therapy GV1001 for Alzheimer’s Disease in Alzheimer's Research & Therapy. GV1001 is a telomerase modulator. Based on the positive Phase 2 clinical results, GemVax plans to conduct a Phase 3 clinical trial in South Korea later this year. (WuXi AppTec)

Disease Control Rate Exceeds 95%! InnoCare Pharma Announces Phase 2 Registrational Clinical Results of Its PI3Kδ Inhibitor

InnoCare Pharma Announces Preliminary Completion of Phase 2 Registrational Clinical Trial of Its PI3Kδ Inhibitor Linperlisib (YY-20394) for the Treatment of Relapsed/Refractory Follicular Lymphoma. Trial data demonstrated positive outcomes with linperlisib: the objective response rate (ORR) exceeded 80%, and the disease control rate (DCR) surpassed 95%. (WuXi AppTec)

Keytruda Treatment for High-Risk Early-Stage Triple-Negative Breast Cancer Receives Complete Response Letter from the US FDA

Merck & Co. recently announced that the U.S. FDA issued a Complete Response Letter (CRL) regarding a supplemental Biologics License Application (sBLA) for the anti-PD-1 therapy Keytruda. The sBLA sought approval of Keytruda for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC), specifically for use in combination with chemotherapy as neoadjuvant (pre-surgical) treatment, followed by Keytruda as a single agent as adjuvant (post-surgical) treatment. TNBC is a difficult-to-treat malignancy, accounting for approximately 15–20% of all breast cancer diagnoses. Merck is reviewing the CRL and will discuss next steps with the FDA. (Bioon)

Roche’s Emicizumab New Indication to Be Approved Soon

Insight database shows that the processing status of Roche’s emicizumab second indication marketing application (acceptance numbers: JXSS2000012/13/14/15) has been changed to "under review," and it is expected to be approved soon. According to the previous priority review public information, the indication about to be approved is for routine prophylactic treatment in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) without inhibitors to factor VIII. (Insight Database)

FDA Accepts AbbVie’s New Drug Application for Atogepant for the Prevention of Migraine in Adults

AbbVie Announces FDA Acceptance of New Drug Application for Atogepant, an Investigational Oral Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist (Gepant), for the Preventive Treatment of Episodic Migraine in Adults. AbbVie Expects a Regulatory Decision by the End of the Third Quarter of 2021. (Insight Database)

CStone Pharmaceuticals’ Precision Anti-Cancer Drug “Avapritinib” Approved

On the 31st, information on drug approval documents pending collection from the NMPA indicated that avapritinib, a KIT and PDGFRA mutant kinase inhibitor submitted by CStone Pharmaceuticals, has been approved in China. Publicly available data show that the indication approved for avapritinib this time is: for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring PDGFRA exon 18 mutations (including the PDGFRA D842V mutation). Notably, this is also the first drug approved in China for the treatment of GIST with PDGFRA exon 18 mutations. (NMPA)

Zai Lab's Innovative Drug Ripretinib Approved in China

Zai Lab Announces NMPA Approval of Qinle® (Ripretinib) Marketing Application for Adult Patients with Advanced Gastrointestinal Stromal Tumors (GIST) Who Have Previously Received Treatment with Three or More Kinase Inhibitors, Including Imatinib. This Approval Marks Ripretinib as the First Fourth-Line Therapy for GIST Approved for Market Launch in Mainland China. (NMPA)

Eli Lilly’s IL-2R Agonist Files for Clinical Trial Approval

The CDE website shows that the clinical trial application for Eli Lilly’s IL-2R agonist LY3471851 injection (NKTR-358) has been officially accepted by the National Medical Products Administration. Impaired IL-2 production and regulatory T cell (Treg) dysfunction are considered to be associated with the pathogenesis of various autoimmune diseases. Although low-dose IL-2 can stimulate Treg cells to achieve clinical benefits, poor pharmacokinetics necessitate daily dosing, adverse events are dose-limiting, and the increase in Treg cells is limited and transient. (PharmaCube)

Tagrisso’s First-Line Indication for NSCLC Included in National Reimbursement Drug List; Postoperative Adjuvant Therapy for Lung Cancer Also Set for Approval

Recently, AstraZeneca’s osimertinib mesylate tablets (brand name: Tagrisso) have entered the administrative approval stage for their Class 2.4 registration application. The drug is expected to soon receive domestic approval for its third indication: adjuvant treatment of adult patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations following tumor resection. (CPhI Pharmaceutical Online)

Huadong Medicine’s Class 1 Biologic Drug IMGN853 Approved for Clinical Trials

Huadong Medicine’s Subsidiary Zhongmei Huadong’s Class 1 Biologic Drug IMGN853 (Mirvetuximab Soravtansine) Approved for Clinical Trials, Indicated for Patients with Platinum-Resistant Advanced High-Grade Epithelial Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer with High Expression of Folate Receptor Alpha. (Insight Database)

Genor Biopharma’s STING Agonist GB492 Clinical Trial Application Accepted

Recently, according to Genor Biopharma’s official website, the Center for Drug Evaluation (CDE) has officially accepted its Investigational New Drug (IND) application for GB492 (IMSA101), a stimulator of interferon genes (STING) agonist. The application seeks approval for Phase I/IIa clinical trials to evaluate the safety and efficacy of GB492 as monotherapy and in combination with a recombinant humanized anti-PD-1/L1 monoclonal antibody in patients with advanced refractory malignant tumors. (PharmCube)

Targeting Claudin 18.2 and 4-1BB! I-Mab’s TJ-CD4B Receives Clinical Trial Approval in the US

I-Mab and South Korea’s ABL Bio jointly announced that TJ-CD4B (also known as ABL111), a bispecific antibody targeting Claudin 18.2 and 4-1BB developed through their collaboration, has received approval from the U.S. FDA to initiate Phase I clinical trials. It is reported that I-Mab also plans to conduct dose-escalation studies of TJ-CD4B in China within this year. (Pharmaceutical Horizon)

Salubris’ SAL0104 Capsules Approved for Clinical Trials for the Prevention and Treatment of Thrombotic Diseases

Salubris announced that it recently received the "Notice of Approval for Clinical Trials" approved and issued by the National Medical Products Administration, agreeing to conduct clinical trials on SAL0104 capsules. (Sina Medical News)

Hisun, Cisen, and Zhejiang Medicine Products Pass Consistency Evaluation

Hisun Pharmaceutical announced that it recently received the "Notice of Approval for Supplementary Drug Application" approved and issued by the National Medical Products Administration (NMPA) for Tigecycline for Injection, indicating that the company’s Tigecycline for Injection has passed the consistency evaluation of quality and efficacy for generic drugs. Chinxin Pharmaceutical announced that its Dexmedetomidine Hydrochloride Injection and Ambroxol Hydrochloride Injection have passed the consistency evaluation of quality and efficacy for generic drugs. Zhejiang Medicine announced that it recently received the "Drug Registration Certificates" approved and issued by the NMPA for Sitagliptin Phosphate Tablets in two strengths (100 mg and 50 mg). The product was approved for registration as a Class 4 chemical drug and, in accordance with relevant regulations, is deemed to have passed the consistency evaluation of drug quality and efficacy. (Corporate Announcements)