Hinova Pharmaceuticals Plunges Nearly 30% on Sci-Tech Board Debut

[April 12, 2022/Medical News at a Glance] Pfizer Replaces Chief Financial Officer; Pfizer’s COVID-19 Vaccine Comirnaty and Oral Drug Paxlovid See Lower-than-Expected Sales in Q1; BGI Genomics: Q1 Net Profit Forecast to Drop by 33.33%-42.85%... Daily Fresh Pharmaceutical News and Medical Information, Speed Reading Club Keeps You Updated!

Policy Brief

Beijing: Deepening the Reform of the Centralized Bulk Procurement System for Medicines and Medical Consumables

On April 12, the Beijing Municipal People's Government issued the "Several Measures on Deepening the Reform of the Medical Security System," which mentioned deepening the reform of the centralized bulk procurement system for medicines and medical consumables. The centralized bulk procurement of medicines and medical consumables will be implemented steadily. It will promote the bulk procurement of medicines and medical consumables in the Beijing-Tianjin-Hebei regional alliance, gradually forming an inter-provincial regional procurement alliance, and explore the formation of a three-level procurement system of "National–Regional Alliance–Provinces/Cities." Continue to expand the scope of centralized procurement of high-value medical consumables. Strengthen the construction of Beijing’s centralized procurement platform for medicines and medical consumables, optimizing the existing platform’s bidding, procurement, transaction, and supervision functions. Improve the coding system for medicines and medical consumables, strengthen data integration, and achieve the sharing of medical security data and business coordination in Beijing. Implement the credit evaluation system for pharmaceutical pricing and procurement. (Beijing Municipal People's Government)

Industry Economics Observation

HaiChuang Pharmaceuticals Plummets Nearly 30% on First Day of STAR Market Listing

On the 12th, Hycan Pharma was listed on the STAR Market with an issue price of 42.92 yuan per share, opening at 41.00 yuan per share, down 4.47%. At the close of trading, Hycan Pharma was at 30.10 yuan per share, down 29.87%, with a total market value of 2.98 billion yuan. (Sina Medicine News)

Pfizer Replaces Chief Financial Officer

On the 11th, Pfizer announced that David M. Denton will serve as the company's Chief Financial Officer (CFO) and Executive Vice President on May 2, 2022, reporting directly to Chairman and Chief Executive Officer Albert Bourla. Former CFO Frank D’Amelio will retire soon after working at Pfizer for 15 years. (Sina Medicine News)

GE Healthcare Replaces Chief Technology Officer in China; Chief Innovation Officer for China, Dai Ying, Resigns

On the evening of April 11, an internal email from GE Healthcare announced that Dai Ying, Chief Innovation Officer for China, has decided to pursue external opportunities, with his term ending on April 26, 2022. At the same time, GE appointed Sun Xuguang, General Manager of Global CT Hardware R&D at GE Healthcare and General Manager of China CT R&D, as the new Chief Technology Officer of GE Healthcare China. Sun Xuguang will report to Zhang Yihao, President and CEO of GE Healthcare China, and officially assume the position on April 27. (Sina Medicine News)

Rongchang Bio Independent Director Shanshan Yu Resigns

Today, Rongchang Bio announced that the board of directors recently received a written resignation report from Ms. Yu Shanshan, an independent director of the company. Due to personal work changes, Ms. Yu Shanshan has voluntarily applied to resign from her positions as an independent director of the company, as well as a member of the Audit Committee and the Chairperson of the Compensation and Evaluation Committee. After her resignation takes effect, she will no longer hold any position within the company. (Corporate Announcement)

Pfizer's COVID-19 Vaccine Comirnaty and Oral Medication Paxlovid Sales Below Expectations in Q1

Cantor Fitzgerald's analyst team, led by Louise Chen, stated in a report to clients that they have lowered the sales forecast for Pfizer's Q1 2022, but maintained their full-year prediction for the company as "unchanged." The downgrade was due to the team’s latest forecast, which estimates that revenue from Pfizer's COVID-19 oral drug Paxlovid and its vaccine Comirnaty will fall below expectations in Q1 this year. (Sina Medicine News)

JIANYI Medical Expects Up to 16 Billion Yuan in Net Profit for the First Quarter

Ninebot Medical announced on the morning of April 12 that it expects to achieve a net profit attributable to shareholders of the listed company of approximately RMB 14 billion to RMB 16 billion in the first quarter of 2022, representing an increase of 36707.43%—41965.63% compared to the same period last year when it made a profit of RMB 38.0358 million; the estimated net profit excluding non-recurring gains and losses is approximately RMB 14 billion to RMB 16 billion, representing an increase of 738452.44%—843959.93% compared to the same period last year; basic earnings per share are approximately RMB 30.7079 per share to RMB 35.0948 per share, compared to RMB 0.0849 per share for the same period last year. During the reporting period, its U.S. subsidiary iHealth sold the iHealth COVID-19 Antigen Test Kit through its own channels and the Amazon platform, and signed significant contracts and orders with customers. (Corporate Announcement)

Saisheng Pharmaceutical Q1: Expected Profit Over 100 Million Yuan, Up 140%-170% Year-on-Year

Today, Sesen Bio announced that the estimated net profit attributable to shareholders for the first quarter of 2022 is RMB 102 million to RMB 115 million, representing a year-on-year increase of 140%-170%. During the reporting period, the fair value change gains recognized under the new financial instruments standards for the company's direct or indirect investments in biopharmaceuticals, medical devices, and companies related to its main business amounted to approximately RMB 70 million, while investment income from associated companies was approximately RMB 20 million. (Corporate Announcement)

BGI: Q1 Net Profit Forecast Down 33.33%-42.85%

Today, BGI Genomics announced that during the reporting period, the company's revenue for the first quarter of 2022 is expected to be approximately 1.4 billion to 1.6 billion yuan, representing a change of -10.45% to 2.34% compared to the same period last year. The net profit attributable to shareholders of the listed company for the first quarter of 2022 is expected to be approximately 300 million to 350 million yuan, representing a decrease of 33.33% to 42.85% compared to the same period last year. (Corporate Announcement)

Pharmaceutical News and Medical Information

For NSCLC Adjuvant Treatment! BeiGene's PD-1+TIGIT Combination Therapy Approved for Clinical Trials

On the 11th, the CDE official website showed that BeiGene's tislelizumab + ociperlimab combination therapy was approved for clinical trials for adjuvant and neoadjuvant treatment of non-small cell lung cancer. Ociperlimab is a TIGIT antibody independently developed by BeiGene and also a first-tier new drug project in this field, which has now entered Phase III clinical development. (CDE)

Zhejiang Medicine's Linezolid Glucose Injection Passes Generic Drug Consistency Evaluation

Today, Zhejiang Medicine announced that it recently received the "Drug Supplemental Application Approval Notice" for two specifications (100ml: 0.2g, 300ml: 0.6g) of Linezolid Glucose Injection issued by the National Medical Products Administration, approving the drug to pass the generic drug quality and efficacy consistency evaluation. Linezolid is a bacterial protein synthesis inhibitor, suitable for the following infections in adults and children caused by susceptible Gram-positive bacteria: nosocomial pneumonia, community-acquired pneumonia, complicated skin or skin and soft tissue infections, including diabetic foot infections without concurrent osteomyelitis, uncomplicated skin or skin and soft tissue infections, and vancomycin-resistant enterococcal infections. (Corporate Announcement)

Jianyou Co., Ltd. Regadenoson Injection 0.4mg/5mL (0.08mg/mL) Receives FDA Drug Registration Approval

Today, Jianyou Co., Ltd. announced that its subsidiary, Hong Kong Jianyou, recently received the approval letter for Regadenoson Injection, 0.4mg/5mL (0.08mg/mL), from the U.S. FDA. This product is used as a stress agent in radionuclide myocardial perfusion imaging and is suitable for patients who are unable to undergo exercise stress testing and require pharmacological stress testing. (Corporate Announcement)

Beat Ibrutinib: BeiGene's Zanubrutinib Successful in Global Head-to-Head Phase III Clinical Trial

Today, BeiGene announced the final response assessment results of the global Phase 3 clinical trial ALPINE study for its BTK inhibitor Brukinsa (zanubrutinib). Confirmed by the Independent Review Committee, Brukinsa demonstrated a superior overall response rate compared to ibrutinib in adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma. (Corporate Announcement)

U.S. FDA Lifts Partial Clinical Hold on Gilead's CD47 Antibody

Recently, Gilead announced that the U.S. FDA has lifted the partial clinical hold on its investigational CD47 monoclonal antibody magrolimab in combination with azacitidine. After reviewing the integrated safety data from each clinical study, the FDA lifted some of the partial clinical holds. Magrolimab is a monoclonal antibody that blocks CD47 signaling, which Gilead acquired in April 2020 for approximately $4.9 billion through the acquisition of Forty Seven. (Sina Medicine News)

Targeting Fabry Disease! Sanofi's New Rare Disease Drug Enters Phase 3 Clinical Trials in China

Recently, the official website of the Chinese Drug Clinical Trial Registration and Information Disclosure Platform announced that Sanofi has launched an international multicenter Phase 3 clinical study in China for venglustat in patients with Fabry disease. Venglustat is an oral GCS inhibitor, and Sanofi is currently conducting Phase 2/3 clinical trials for this drug targeting multiple rare disease indications. (MedView)

Median EFS exceeds 31 months! BMS announces updated Phase 3 clinical data for Opdivo + chemotherapy as neoadjuvant treatment for lung cancer

On the 11th, Bristol-Myers Squibb (BMS) announced the data of the primary endpoint, event-free survival (EFS), from the Phase 3 clinical trial CheckMate-816. The study results showed that: the median EFS of patients with resectable non-small cell lung cancer (NSCLC) who received three cycles of neoadjuvant treatment with nivolumab combined with chemotherapy before surgery reached 31.6 months, significantly higher than 20.8 months in the group treated with chemotherapy alone; receiving nivolumab combined with chemotherapy before surgery reduced the risk of disease recurrence, progression, or death by 37%. (MedView)

Veru's Oral COVID-19 Drug Succeeds in Phase III Trial

On the 11th, Veru announced that sabizabulin (bisindole) reduced the relative risk of death by 55% in hospitalized patients with moderate to severe COVID-19. Due to the positive data, the independent data monitoring committee recommended early termination of the clinical trial. Veru plans to communicate with the FDA soon to seek emergency use authorization. (Medcube)

mRNA Vaccine Boosts CAR-T Therapy, Overall Response Rate for Solid Tumors at 43%

Recently, BioNTech announced the first human clinical trial results of its next-generation CAR-T therapy, BNT211, targeting solid tumors. The trial results showed that this therapy demonstrated encouraging safety and exhibited anti-cancer activity in testicular cancer. BNT211 is a potential "first-in-class" treatment strategy that combines a CAR-T therapy targeting the CLDN6 antigen with a CARVac expressing the CLDN6 antigen. This vaccine expresses CLDN6 on the surface of antigen-presenting cells, stimulating the expansion of CAR-T cells in the body. (WuXi AppTec)

Treatment of Bladder Cancer: Bicyclic Peptide Conjugate Therapy Achieves 50% Objective Response Rate

Bicycle Therapeutics Presents Updated Clinical Trial Results for BT8009, a Bicyclic Peptide-based Investigational Therapy, at AACR Annual MeetingBicycle Therapeutics announced today at the AACR Annual Meeting the latest clinical trial results for its investigational therapy BT8009, which is based on bicyclic peptides. BT8009 is the company's second-generation bicyclic peptide toxin conjugate targeting Nectin-4. The trial results showed that in the cohort of urothelial cancer patients receiving BT8009 treatment at a dose of 5.0 mg/m² weekly, the confirmed overall response rate reached 50%. (WuXi AppTec)

NOC Health Releases ICP-723 Preclinical Data at the 2022 AACR Annual Meeting

On the 11th, InnoCare announced that it had presented the preclinical data of its self-developed pan-TRK small molecule inhibitor ICP-723 at the 113th American Association for Cancer Research (AACR) Annual Meeting in 2022. The research results showed that ICP-723 can effectively inhibit the kinase activity of TRKA, TRKB, and TRKC (IC50 value less than 1 nM). ICP-723 not only demonstrated potent in vitro efficacy in TRK-driven tumors but also overcame resistance mutations that often occur after the treatment with first-generation TRK inhibitors, such as TRKA G595R and TRKC G623R/E. (Sina Medicine News)

SAL0114 Tablets, a Class 1 New Drug by Sinopharm, Initiate Clinical Trials for Depression Treatment

On the 11th, according to the Insight database, SAL0114 tablets, a Class 1 new drug developed by Salubris, have entered clinical trials for the indication of depression. Based on clinical trial registration information, SAL0114 is deuterium dextromethorphan tablets. In February this year, two indications for SAL0114 were successively approved for clinical trials, including not only major depressive disorder but also agitation in Alzheimer's disease. (Insight Database)