Second Round of National Centralized Drug Procurement Concludes; Five New Drugs Listed in '2019 China Medical Major Advances'

On January 17, the bid opening for the second round of national centralized drug procurement will take place in Shanghai. This round covers 33 drug varieties spanning therapeutic areas such as diabetes, hypertension, cancer, and rare diseases, involving more than 100 pharmaceutical manufacturers. The baseline procurement volume is 12.4 billion tablets, with the contracted procurement volume for each variety set at 50–80% of this baseline. The proposed winning bidders will be determined today; the results will be officially released after a three-day public notice period. Patients across China will have access to these drugs starting in April.

Jiangsu Tasly and Changchun Haiyue Win Bid for Tadalafil

On the morning of January 17, the second round of national volume-based procurement (VBP) officially kicked off, with corporate bids being announced sequentially. In this round of VBP bidding, five companies submitted quotes for tadalafil: Changchun Haiyue, Qilu Pharmaceutical (Hainan), Nanjing Chia Tai Tianqing, Eli Lilly, and Jiangsu Tasly. Based on the quoted prices, Jiangsu Tasly and Changchun Haiyue won the bid with per-unit arithmetic prices of 42.4 and 47.0304, respectively. Although Qilu Pharmaceutical’s quote ranked third, it unfortunately failed to win the bid because its price exceeded 1.8 times that of Tasly’s and was more than 50% above the maximum declared price ceiling. Nanjing Chia Tai Tianqing and Eli Lilly were also eliminated.

Bayer's Acarbose Sees Over 90% Price Drop

On January 17, the bidding for the second batch of volume-based procurement was officially opened in Shanghai. During the bidding process, Jingxin Pharmaceutical won the bid for simvastatin, Hengrui Medicine won the bid for abiraterone oral immediate-release tablets, and Guangshengtang won the bid for adefovir dipivoxil oral immediate-release tablets. Among foreign companies, Bayer won the bid for acarbose oral immediate-release tablets, and Boehringer Ingelheim won the bid for meloxicam oral immediate-release tablets. It is reported that in the bidding for the second batch of volume-based procurement, the companies competing for acarbose included Zhongmei Huadong, a subsidiary of Huadong Medicine, Luye Pharma, and Bayer, with bids of 13.96 yuan, 9.6 yuan, and 5.42 yuan respectively, all for the specification of 50mg/30 tablets.

Candesartan reduction exceeds 80%

On the morning of January 17, the second round of national volume-based procurement officially kicked off, with corporate bidding results being announced sequentially. For candesartan oral immediate-release tablets (8 mg × 14 tablets), Zhejiang Yongning Pharmaceutical submitted a bid of RMB 3.69, equivalent to RMB 0.26 per tablet. This represents an 86% price reduction compared to the 2019 national lowest price of RMB 1.88 per tablet.

Clinical Oncology Company Treadwell Secures $27 Million in Seed Funding to Develop Novel Small-Molecule Anticancer Drugs

On January 13, 2020, clinical oncology company Treadwell Therapeutics completed a $27 million seed financing round. The round was led by TIO Bioventures and will be used to develop novel small-molecule anticancer drugs. Treadwell Therapeutics is currently developing an oral immunomodulatory kinase inhibitor that targets the undeveloped immuno-oncology target HPK1.

AIImaging CompanyLunitAwarded2600USD 10,000Cround of financing, advancing product R&D in oncology and pathology

Recently, South Korean medical AI company Lunit completed a $26 million Series C financing round. The round was led by Shinhan Investment, with participation from Asian investors including InterVest, IMM Investment, Kakao Ventures, and Legend Holdings’ Lenovo Capital (Junlian Capital). The funds will be used to accelerate global sales of its Lunit INSIGHT software suite for chest and mammography X-ray examinations. Additionally, the capital will support product development in oncology and pathology, leveraging AI to digitize histopathological tissue data and predict the efficacy and safety of various cancer treatment regimens for individual patients.

ZhiMeng Pharma’s Self-Developed Inhibitor ZM-H1505R Receives FDA Clearance for Clinical Trials

On January 17, Shanghai ZhiMeng Pharmaceutical Technology Co., Ltd. announced that its independently developed next-generation viral capsid inhibitor for the treatment of chronic hepatitis B, ZM-H1505R, officially received investigational new drug (IND) approval from the U.S. Food and Drug Administration (FDA) on January 14, 2020, U.S. local time. Notably, ZM-H1505R is the first product in ZhiMeng Pharmaceutical’s hepatitis B virus (HBV) research and development pipeline to receive FDA clearance for clinical trials, featuring a novel mechanism of action.

Novo Nordisk’s GLP-1 Diabetes Drug Ozempic Receives FDA Approval for Label Expansion

Recently, diabetes giant Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for Ozempic (semaglutide, subcutaneous formulation, once weekly) based on a supplemental New Drug Application (sNDA). The approval is for reducing the risk of major adverse cardiovascular events (MACE, including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke) in adult patients with type 2 diabetes who have established cardiovascular disease (CVD). This approval is based on the SUSTAIN 6 cardiovascular outcomes trial (CVOT).

Qianyuan Pharmaceutical’s Ambroxol Hydrochloride Dispersible Tablets Pass the Consistency Evaluation; Indicated for Patients with Viscous Sputum That Is Difficult to Expectorate

On January 17, 2020, Qianyuan Pharmaceutical announced that the Company had recently received the "Approval for Supplementary Drug Application" for "Ambroxol Hydrochloride Dispersible Tablets," approved and issued by the National Medical Products Administration (NMPA). The drug has passed the Consistency Evaluation of Quality and Efficacy for Generic Drugs. Ambroxol Hydrochloride Dispersible Tablets are indicated for patients with viscous sputum that is difficult to expectorate. As of the announcement date, the Company is among the enterprises whose product in the "dispersible tablet" dosage form has passed the consistency evaluation. This product is currently included in the National Reimbursement Drug List and the National Essential Medicines List.

UCB’s Cimzia Approved in Canada for the Treatment of Non-Radiographic Axial Spondyloarthritis

Recently, Belgian pharmaceutical giant UCB announced that Health Canada has approved a new indication for Cimzia® (generic name: certolizumab pegol), namely the treatment of adult patients with severe active non-radiographic axial spondyloarthritis (nr-axSpA) who have objective evidence of inflammation (elevated C-reactive protein and/or MRI findings) and an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs). This approval also marks the fifth indication for Cimzia in Canada.

ViiV Healthcare’s Single-Tablet, Two-Drug Regimen Dovato (DTG/3TC) Approved in Japan

Recently, ViiV Healthcare, a company dedicated to the research and development of HIV/AIDS medications, announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Dovato (dolutegravir/lamivudine, DTG/3TC, 50 mg/300 mg) for the treatment of adults and adolescents aged over 12 years and weighing at least 40 kg who are infected with HIV-1. The medication is administered orally once daily, with or without food. In the United States and the European Union, Dovato was approved in April and July 2019, respectively, although the approved indications differ.

Johnson & Johnson’s Spravato Nasal Spray Submits Application to EMA for New Indication in Treating Patients with Acute Suicidal Ideation

Recently, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, announced that it has submitted a Class II variation application to the European Medicines Agency (EMA) for Spravato (esketamine) nasal spray, a new drug for depression. The application aims to expand the use of Spravato beyond its current indications, serving as an acute short-term treatment in combination with oral antidepressants to rapidly reduce depressive symptoms in adult patients with major depressive disorder (MDD) who are experiencing a moderate-to-severe depressive episode and have suicidal ideation. If approved, Spravato would become the first medication indicated for this severely ill patient population, which is typically excluded from antidepressant treatment studies.

Five New Drugs Selected for “Major Medical Advances in China 2019”

On January 13, the Chinese Academy of Medical Sciences released the “Major Medical Advances in China in 2019,” which included seven achievements selected as “Major Advances in Pharmacy,” comprising five global new drugs and two basic research findings. The five global new drugs are roxadustat, zanubrutinib, sodium oligomannate capsules, cliamycin, and benvitimod cream.

Japan’s 5-Year Cancer Survival Rate Rises to 66.4%

Recently, data released by the National Cancer Center Japan showed that the five-year survival rate for patients diagnosed with cancer in 2010–2011 at nationwide specialized cancer hospitals, such as Designated Hospitals for Collaborative Cancer Care, was 66.4%, representing a 0.3 percentage point increase compared to the 2009–2010 period. This marks the fifth calculation of the five-year survival rate for cancer patients, which continues to demonstrate an improving trend.

Three Departments Issue Three Key Points for Implementing the "Administrative Measures on Imported Medicinal Materials"

On January 16, the National Medical Products Administration (NMPA) issued the Announcement on Matters Concerning the Implementation of the Administrative Measures for Imported Medicinal Materials (Announcement No. 3 of 2020). The announcement highlights key considerations in three areas: application and approval for first-time imports of medicinal materials, filing requirements for imported medicinal materials, and port-of-entry inspection of imported medicinal materials.