Hengrui Medicine Appoints Dr. Xuejian Xu as New Chief Quality Officer Amid FDA Warning Letter Follow-up

Hengrui Pharma Receives Follow-up Progress After Receiving FDA Warning Letter.

On July 29, Hengrui Pharma announced that Dr. Xuejian Xu, who has extensive experience in quality management within the pharmaceuticals industry, has officially joined Hengrui Pharma as Vice General Manager and Chief Quality Officer, taking full responsibility for the company’s quality management operations.

A-Share Earnings Preview Continues.

On July 29, SINOMEDHealthcareSINOMED and Bio-Thera have successively released earnings forecasts. SINOMED announced an estimated net profit of 7.66 million yuan for the first half of the year, reversing a year-on-year loss. Bio-Thera announced that it expects to continue incurring losses for the first half of 2024, with the loss amounting to between 220 million and 280 million yuan.

CLDN18.2 Monoclonal Antibody Recommended for EU Market Approval.

Recently, Astellas announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the approval of zolbetuximab in combination with fluorouracil-containing or platinum-containing chemotherapy for first-line treatment of adult patients with CLDN18.2-positive, locally advanced unresectable or metastatic HER2-negative gastric cancer or gastroesophageal junction adenocarcinoma in the EU.

In the past day, what are the hot topics in the pharmaceutical markets at home and abroad that are worth paying attention to? Let Amino take you to explore.

/ 01 / Market Express

1) Hengrui Pharma Appoints New Chief Quality Officer

On July 29, Hengrui Pharma announced that Dr. Xuejian Xu, who has extensive experience in quality management within the pharmaceutical industry, officially joined the company as Vice General Manager and Chief Quality Officer, taking full responsibility for the company’s quality management operations.

2) Livzon Pharmaceutical Group Inc. Plans to Establish a Joint Venture in Indonesia

On July 29, Livzon Pharmaceutical Group Inc. announced that it plans to establish a joint venture in Indonesia with cash investment. The joint venture will mainly engage in the production of active pharmaceutical ingredients, aiming to expand the overseas market, which aligns with the company's medium and long-term strategic development goals.

3) Aier Eye Hospital Group Co., Ltd. Plans to Acquire Partial Equity in 35 Hospitals

On July 29, Aier Eye Hospital Group Co., Ltd. announced that the company plans to acquire partial equity in 35 hospitals, including Humen Aier and Yuncheng Aier, for a total price of 8.98 billion yuan through self-owned funds.

/ 02 / Capital Information

1) SINOMED Expects Net Profit of 7.66 Million Yuan in the First Half of the Year

On July 29, SINOMED announced that it expects a net profit of 7.66 million yuan for the first half of the year, reversing a loss from the same period last year.

2) Bio-Thera Solutions, Ltd. expects a net loss of 220 million to 280 million yuan in the first half of the year

On July 29, Bio-Thera announced that it expects to continue incurring losses for the first half of 2024, with a loss amounting to between 220 million yuan and 280 million yuan.

3) iFlytek Healthcare Submits Application for Listing on HKEX

On July 26, the HKEX official website showed that iFlytek Healthcare submitted its listing application to the HKEX.

/ 03 / Pharmaceutical Updates

1) Zenitar ZL-82 Tablets Approved for Clinical Trials

On July 29, according to the CDE official website, Zenitar's ZL-82 tablets have been approved for clinical trials and are proposed to be studied for the treatment of atopic dermatitis.

2) Sanxingdui Pharma's SL001 Approved for Clinical Trials

On July 29, according to the CDE official website, Samsungdui Pharmaceutical's SL001 was approved for clinical trials, aiming to conduct research on the treatment of male erectile dysfunction.

3) SAL0120 Tablets by Sinopharm Xinyi Pharmaceutical Approved for Clinical Trials

On July 29, according to the CDE website, SAL0120 tablets developed by Salubris Pharmaceuticals were approved for clinical trials and are proposed to be studied for the treatment of chronic kidney disease.

4) AbbVie's ABBV-382 Injection Approved for Clinical Use

On July 29, according to the CDE website, AbbVie's ABBV-382 injection has been approved for clinical trials, aiming to continuously suppress immune-mediated HIV without combined antiretroviral therapy.

5) Hengrui Pharma's SHR-1819 Injection Approved for Clinical Trials

On July 29, according to the CDE official website, Hengrui Pharma's SHR-1819 injection has been approved for clinical trials, aiming to conduct research on the treatment of prurigo nodularis.

6) Hengrui Pharma's HRS-4508 Tablet Approved for Clinical Trials

On July 29, according to the CDE website, Hengrui Pharma's HRS-4508 tablet has been approved for clinical trials, which are expected to be conducted for the treatment of solid tumors.

7) Zhifei Biological Quadrivalent Recombinant Norovirus Vaccine Enters Phase III Clinical Trial

On July 29, Zhifei Biological Products announced that the Phase III clinical trial of the quadrivalent recombinant norovirus vaccine had been launched in Guangxi, Hunan, and Sichuan.

/ 04 / Device Tracking

1) Zenitar Bronchoscope Placement Navigation System Approved for Marketing

On July 29, according to the NMPA website, Broncus Biomedical's bronchoscope placement navigation system was approved for marketing.

2) Bomei Yuantong Intracranial Balloon Dilation Catheter Approved for Marketing

On July 29, according to the NMPA website, Bomayuantong Intracranial Balloon Dilation Catheter was approved for marketing.

3) Yizhun Intelligent Coronary CTA Image Vessel Stenosis Auxiliary Assessment Software Approved for Marketing

On July 29, according to the NMPA website, Yizhun Intelligence's coronary CT angiography image vascular stenosis auxiliary assessment software was approved for marketing.

4) Venus Medtech's Transcatheter Aortic Valve Replacement Retrievable Delivery System and other multiple products have been approved for marketing

On July 29, according to the NMPA website, Venus MedTech's Transcatheter Aortic Valve Replacement Retrievable Delivery System, Peripheral Vascular Balloon Dilation Catheter, and several other products have been approved for marketing.

5) Ruichu Technology's Puncture Surgery Navigation and Positioning System Approved for Marketing

On July 29, according to the NMPA website, the puncture surgery navigation and positioning system developed by Rui Chu Technology was approved for marketing.

6) Sanyou Medical's 3D Printed Metal Additive Manufacturing Cervical Fusion Device Approved for Marketing

On July 29, Sanyou Medical announced that its 3D-printed "Metal Additive Manufacturing Cervical Fusion Cage" had obtained a medical device registration certificate.

/ 05 / Overseas Pharma News

1) Positive Results from Phase III Study of Acalabrutinib as First-Line Treatment for CLL

On July 29, AstraZeneca announced that the Phase III AMPLIFY (ACE-CL-311) study of acalabrutinib for the treatment of chronic lymphocytic leukemia (CLL) achieved positive results in the interim analysis.

2) CLDN18.2 Monoclonal Antibody Recommended for EU Market Approval

Recently, Astellas announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended the approval of zolbetuximab in combination with fluorouracil-containing or platinum-containing chemotherapy within the European Union for the first-line treatment of adult patients with CLDN18.2-positive, locally advanced unresectable or metastatic HER2-negative gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma.

       Title: Hengrui Pharma Appoints New Chief Quality Officer; Bio-Thera Projects Over 200 Million Yuan Loss in First Half of the Year