Luye Pharma Plans to Spin Off Boan Biotech for HKEX Listing

[January 24, 2022 / Pharmaceutical News Overview]And誉 Pharmaceutical orally-administered PD-L1 inhibitor submitted for clinical trial; Luye Pharmaceutical plans to spin off Boan Biotech for IPO; Merck's GLP-1R/GCGR dual agonist submitted for clinical trial in China...Daily fresh pharmaceutical news and medical updates, Speed Reading Society keeps you informed!

Part 1 Policy Brief

Tianjin Medical Insurance Bureau Completes Multiple Medical Consumables Group Purchases, Driving Significant Price Reductions

On the 24th, the Tianjin Municipal Medical Insurance Bureau fully utilized the advantages of the Beijing-Tianjin-Hebei "3+N" medical product centralized procurement alliance. By adopting a "volume-based linkage and two-way selection" approach, it successfully completed the centralized procurement work for medical consumables such as artificial crystals, drug-coated balloons, and pacemakers, significantly reducing prices. Currently, the number of provinces participating in the Beijing-Tianjin-Hebei "3+N" procurement alliance has reached 23, with 14 provinces participating in the artificial crystal procurement, 10 provinces in the drug-coated balloon procurement, and 12 provinces in the pacemaker procurement. (CCTV News)

CDE Releases "Statistical Guiding Principles for Centralized Monitoring of Drug Clinical Trials (Trial)"

Recently, the CDE has formulated the "Statistical Guidance Principles for Centralized Monitoring of Drug Clinical Trials (Trial)". According to the requirements of the "Notice of the General Office of the National Medical Products Administration on Issuing the Release Procedure of Pharmaceutical Technical Guidelines", after review and approval by the NMPA, it is hereby released and will be implemented from the date of release. (CDE)

The Yangtze River Delta (Shanghai, Zhejiang, Anhui) Alliance Region Drug Procurement Initiative Commences

On the afternoon of the 24th, the Shanghai Sunshine Pharmaceutical Procurement Network released the drug centralized procurement documents for the Yangtze River Delta (Shanghai, Zhejiang, Anhui) alliance regions. According to the procurement product list, a total of 47 varieties are involved, most of which are oral conventional release dosage forms. In addition, there are also injections, tablets, granules, and other dosage forms. (Shanghai Sunshine Pharmaceutical Procurement Network)

Part 2: Industry Economy Observation

Betta Pharmaceuticals Appoints Cai Wanyu as Senior Vice President

On the 23rd, Betta Pharmaceuticals announced that the board of directors has agreed to appoint Vice President Cai Wanyu as the company's Senior Vice President. He will be responsible for the management of the production center and the Shengzhou Industrial Base. His term will last from the date of approval by the board of directors until the end of the third board’s term. (Corporate Announcement)

Aiboi Medical's Net Profit in 2021 Expected to Increase by 65.7%-86.42%

On the 24th, Aibomed announced its 2021 annual earnings forecast, expecting the net profit attributable to the parent company's owners for the year 2021 to be between 160 million and 180 million yuan, an increase of 63.4417 million to 83.4417 million yuan compared to the same period last year, representing a year-on-year increase of 65.7% to 86.42%. (Corporate Announcement)

Heartpulse Medical 2021 Net Profit Increase Forecast: 40%-50%

On the 24th, Endovastec released its earnings forecast, expecting a net profit of 300 million to 320 million yuan in 2021, representing a year-on-year increase of 40%-50%. (Corporate Announcement)

Hankyu Pharmaceutical 2021 Profit Forecast: RMB 25-37.5 Million, Turning Loss into Profit Year-on-Year

On the 24th, Hanyu Pharmaceutical announced that the estimated net profit attributable to shareholders of the listed company in 2021 will be RMB 25 million - RMB 37.5 million, compared with a loss of RMB 609.4272 million in the same period last year; after deducting non-recurring gains and losses, the net loss will be RMB 380 million - RMB 430 million, compared with a loss of RMB 625.0147 million in the same period last year. (Corporate Announcement)

Luye Pharma Plans to Spin Off Boan Biotech and List on HKEX

On the 24th, Luye Pharma announced that the Hong Kong Stock Exchange has confirmed that the proposed spin-off of Boan Biotech and its independent listing can proceed under Listing Rule Application Guideline 15. It is reported that Luye Pharma holds 74.5% of Boan Biotech’s shares. (MedDRA)

Jiangsu Wuzhong Terminates $700 Million Acquisition Due to Unresolved Litigation Disputes

On the 22nd, Jiangsu Wu Zhong Pharmaceutical announced that due to ongoing litigation disputes involving Venna Hong Kong and Mr. Li Shanyong, the company has terminated the proposed acquisition of Shanghai Venna for 700 million RMB. (Corporate Announcement)

Polish pharmaceutical company Polpharma intends to jointly acquire former Sanofi generics unit Zentiva for $4 billion

Reuters reported that Polpharma, Poland's largest pharmaceutical manufacturer, is seeking potential partners for a joint acquisition of Zentiva, Sanofi's European generics division. Sources indicated that the valuation of this acquisition of Zentiva could reach up to 3.5 billion euros ($4 billion). (Sina Medicine News)

Hualan Vaccine to Make Debut on ChiNext on February 8

On the evening of the 23rd, Hualan Vaccine released a prospectus, and the CSRC has approved the company's registration application for its initial public offering of shares. The 40.01 million new shares are scheduled to debut on the STAR Market on February 8, 2022. (Corporate Announcement)

JIUCARE Plummets as It Claims Selection for U.S. Government's New Free COVID-19 Test Kit Program

On the 24th, Jiuan Medical announced on the investor interaction platform that its test kit is among the free COVID-19 test kits newly introduced by the U.S. government. As of today's closing, Jiuan Medical hit the lower limit at RMB 62.9 per share, with a trading volume of RMB 275 million and a total market value of RMB 30.104 billion. (Investor Interaction Platform)

Ruijian Pharmaceuticals Completes Nearly 100 Million Yuan in Series A+ Financing to Develop Universal Cell Drugs

Recently, Ru Jian Pharmaceutical announced the completion of nearly 100 million yuan in A+ round financing. According to the press release, this round of financing will mainly be used to promote the Phase I clinical study of Ru Jian Pharmaceutical's pipeline NouvNeu001, which is under research for Parkinson’s disease, and at the same time support the company's subsequent pipeline NS001 in the dual application for new drug clinical research in China and the United States. (MedView)

Yuxi Pharmaceuticals Completes Pre-A Round Financing Worth Tens of Millions for Technology R&D and Team Expansion

On the 24th, it was reported that Yuxi Pharmaceutical had completed a Pre-A round of financing worth tens of millions of yuan. The funds from this round will mainly be used for product clinical trials, pipeline research and development, innovative technology platform construction, and team expansion. (MedView)

Part 3 Pharmaceutical News and Medical Information

New Drug for Atopic Dermatitis! IL-13Rα1-Targeted Monoclonal Antibody Eblasakimab Can Block Type 2 Receptors

Recently, ASLAN Pharma announced that the first patient has been screened in a Phase 2b dose-ranging clinical study evaluating eblasakimab for the treatment of adult patients with moderate to severe atopic dermatitis. In the intent-to-treat population, at Week 8 of treatment: the eblasakimab treatment group showed a statistically significant improvement of 61% in the primary efficacy endpoint, compared to 32% in the placebo group. Additionally, the eblasakimab treatment group demonstrated statistically significant improvements across all key secondary endpoints compared to placebo. Among patients receiving eblasakimab 600mg once weekly, 50% achieved EASI-75, compared to only 13% in the placebo group. Eblasakimab was well-tolerated at all doses with no safety concerns reported. (Bioon.com)

First-Line Treatment for Advanced Gastric Cancer: Natural Killer Cell Therapy Receives Fast Track Designation

Recently, Celularity announced that the FDA has granted Fast Track designation to its investigational gene-modified, cryopreserved human placental hematopoietic stem cell-derived natural killer cell therapy, CYNK-101. CYNK-101 is genetically engineered to enhance antibody-dependent cellular cytotoxicity, creating synergistic effects with approved antibody therapies. (WuXi AppTec)

Zhirui Jianjin's Second-Generation RET Original Drug for All Cancer Types Receives FDA Clinical Approval in the U.S.

Zhijian Jinrui Biopharmaceuticals announced that the FDA has approved the clinical trial application for its breakthrough new drug, the second-generation RET inhibitor APS03118, which is effective against various types of cancer. APS03118 primarily targets patients with non-small cell lung cancer, thyroid cancer, pancreatic cancer, breast cancer, ovarian cancer, colorectal cancer, and other advanced solid tumors caused by RET gene alterations, as well as patients who have developed resistance to first-generation selective RET inhibitors. (Sina Medicine News)

Huahai Pharmaceutical's Empagliflozin and Linagliptin Tablets Receive Temporary FDA Approval

On the 24th, Huahai Pharmaceutical announced that its preparation product Empagliflozin Linagliptin Tablets received a tentative approval number from the U.S. FDA. Empagliflozin Linagliptin Tablets are mainly used as an adjunctive treatment for adult patients with type 2 diabetes. (Corporate Announcement)

Hengrui Medicine's Nimodipine Oral Solution Receives Drug Registration Certificate

On the 24th, Hengrui Medicine announced that Nimodipine Oral Solution had obtained a drug registration certificate. Nimodipine Oral Solution is suitable for adult patients with subarachnoid hemorrhage caused by ruptured intracranial saccular aneurysms. The marketing authorization application for the subsidiary's drug Adebrelimab Injection has been accepted. (Corporate Announcement)

Bristol-Myers Squibb's "First-in-Class" Anemia Therapy Expected to Be Approved for Marketing in China Soon

The latest announcement on the NMPA official website shows that the listing application status of Reblozyl (Luspatercept for Injection), submitted by Celgene under Bristol Myers Squibb, has been updated to "under review." This indicates that the drug is expected to be approved in China soon. Public information reveals that Luspatercept is a "first-in-class" erythroid maturation agent. The indication applied for in this submission is: for the treatment of adult patients with beta-thalassemia who require regular red blood cell transfusions. (NMPA)

Yabao Pharmaceutical's Celecoxib Capsules Approved for Marketing in China

Recently, Yabao Pharmaceutical announced that its wholly-owned subsidiary, Beijing Yabao Bio-pharmaceutical, had received approval for the production of Celecoxib Capsules as a Category 4 generic drug, which is considered to have passed the evaluation. Data shows that Celecoxib Capsules are mainly used to relieve the symptoms and signs of osteoarthritis, adult rheumatoid arthritis, and ankylosing spondylitis, as well as to treat acute pain in adults. (Corporate Announcement)

Qilu Pharmaceutical's Peramivir Injection Submitted for Production Approval as a Category 3 Generic Drug

Recently, the CDE official website showed that the production application of Qilu Pharmaceutical's Peramivir Injection was accepted as a Category 3 generic drug. Peramivir is an anti-influenza virus drug. (CDE)

Changjiang Health Cefazolin Sodium for Injection Approved and Passed Review via Supplemental Application

Recently, Changjiang Health announced that its wholly-owned subsidiary, Hainan Ling Chemical Pharmaceutical, had received approval for the supplementary application of cefazolin sodium for injection. Data shows that cefazolin sodium is a first-generation cephalosporin with a broad antibacterial spectrum, suitable for treating respiratory tract infections, urinary tract infections, skin and soft tissue infections, bone and joint infections, sepsis, infective endocarditis, hepatobiliary system infections, reproductive system infections, and perioperative prophylaxis of infections caused by susceptible bacteria. (Corporate Announcement)

BioKangtai Subsidiary Receives Notification for On-Site Inspection of Freeze-Dried Human Rabies Vaccine Registration

On the 24th, Kangtai Bio announced that its wholly-owned subsidiary, Minhai Bio, recently received a notice from the CDE to initiate a drug registration inspection for the freeze-dried human rabies vaccine (human diploid cells) that Minhai Bio has applied for registration. After passing technical review, on-site registration inspection, and other related evaluation and approval procedures, the product will be eligible to obtain a drug registration certificate. (Corporate Announcement)

CSPC Holding Subsidiary's Omeprazole Enteric-Coated Capsules Pass Generic Drug Consistency Evaluation

On the 24th, Conba released an announcement stating that the omeprazole enteric-coated capsules of its holding subsidiary have passed the generic drug consistency evaluation. Omeprazole enteric-coated capsules are suitable for the treatment of gastric ulcers, duodenal ulcers, stress ulcers, reflux esophagitis, and Zollinger-Ellison syndrome; used for short-term relief of heartburn and acid reflux symptoms caused by excessive stomach acid. (Corporate Announcement)

Innovent's Pemazyre Approved in Hong Kong, China for Treating Specific Cholangiocarcinoma

On the 24th, Innovent Biologics announced that Pemazyre has been approved by the Department of Health of the Hong Kong Special Administrative Region Government for the treatment of adults with locally advanced or metastatic cholangiocarcinoma who have progressed on at least one prior systemic therapy and harbor fibroblast growth factor receptor 2 (FGFR2) fusions or rearrangements, and are not candidates for surgical resection. (Medlive)

Northeast Pharmaceutical "Carboprost Tromethamine" API Registration Application Approved by CDE

On the 24th, Northeast Pharmaceutical announced that the company's registration application for the raw material drug "Carboprost Tromethamine" has passed the CDE approval. Carboprost Tromethamine is a prostaglandin-class drug, mainly used for abortions during the 13th to 20th week of pregnancy and postpartum hemorrhage caused by ineffective uterine contractions after conventional treatment methods. (Corporate Announcement)

FDA Approves Clinical Trial Application for HG030 Tablets by Chengdu先导

On the 24th, Chengdu先导 issued an announcement stating that the company's Class 1.1 anti-tumor innovative drug HG030 project has been approved by the U.S. FDA to conduct clinical trials. The announcement shows that HG030 is a second-generation Trk oral small molecule inhibitor, which is clinically intended for first-line treatment of NTRK or ROS1 gene fusion tumors and can also be used for solid tumor patients carrying acquired mutations that are resistant to first-generation drugs. (Corporate Announcement)

And誉 Pharmaceutical's Oral PD-L1 Inhibitor Submitted for Clinical Trial

On the 24th, the CDE official website showed that the clinical trial application of ABSK043 capsule from And誉 Medicine was accepted by NMPA. ABSK043 is a novel oral small molecule PD-L1 inhibitor with excellent activity and selectivity. (CDE)

Merck's GLP-1R/GCGR Dual Agonist Submitted for Clinical Trial in China

On the 24th, the CDE official website showed that Merck's Efinopegdutide clinical application in China has been accepted. Efinopegdutide is a GLP-1/GCGR dual agonist injected once a week. (CDE)