China National Pharmaceutical Chairman Resigns; FDA Approves Expanded Indication for Parkinson’s Drug Gocovri

[February 3, 2021 / Pharmaceutical News Overview]Chairman of China National Pharmaceutical Group Resigns; FDA Approves Expanded Indications for New Parkinson’s Disease Drug; Bayer’s Norvego Approved in China...Daily Fresh Pharmaceutical and Medical News: Sudu She Joins You in Paying Close Attention!

Part 1 Policy Brief

Hebei Reports One New Locally Transmitted Confirmed Case

From 0:00 to 24:00 on February 2, 2021, Hebei Province reported one new locally transmitted confirmed case of novel coronavirus pneumonia (Shijiazhuang City); no new asymptomatic infections were reported. Two asymptomatic infections were released from isolation for medical observation. (Hebei Provincial Health Commission)

Beijing Reports No New Locally Transmitted Confirmed Cases for Four Consecutive Days

From 0:00 to 24:00 on February 2, Beijing reported no new locally confirmed cases, suspected cases, or asymptomatic infections; no new imported confirmed cases, suspected cases, or asymptomatic infections were reported. (Beijing Municipal Health Commission)

Fourth Round of National Centralized Drug Procurement Opens Bids in Shanghai Today: Involving 45 Varieties

The fourth round of China’s National Centralized Drug Procurement opened for bidding in Shanghai today. This round covers 45 drug varieties, with a maximum procurement volume exceeding RMB 25 billion. Notably, inhalation preparations were included in the national centralized procurement for the first time. Additionally, following the official launch of the consistency evaluation for injectables in May 2020, eight injectable products, including pantoprazole for injection, were also included in this procurement round. (Sci-Tech Innovation Board Daily)

Products Not Listed on the Jiangsu Provincial Platform Without National Medical Insurance Drug Codes Will Be Ineligible for Sunshine Procurement

Recently, the Jiangsu Provincial Public Resource Trading Center issued a notice on implementing the National Healthcare Security Administration (NHSA) drug coding standards, requiring Jiangsu Province to standardize the classification and codes of NHSA-covered drugs on the provincial platform. The notice stipulates that for products not listed on the provincial platform, those without NHSA drug classification and codes will be ineligible to apply for participation in the Provincial Drug Sunshine Procurement program starting from February 16, 2021. (Jiangsu Provincial Public Resource Trading Center)

Jiangxi Issues “Implementation Opinions on Strengthening the Construction of Public Health Functions in Public Hospitals”

Recently, Jiangxi Province issued the "Implementation Opinions on Strengthening the Construction of Public Health Functions in Public Hospitals." The "Opinions" propose main tasks covering six aspects, including strengthening the public health responsibilities of public hospitals, optimizing the public health management structure of public hospitals, enhancing the emergency treatment capabilities of public hospitals, establishing a public health emergency response mechanism for public hospitals, innovating medical-prevention coordination mechanisms, and improving the public health support mechanism for public hospitals. (Jiangxi Provincial Government)

Part 2: Industry and Economic Observation

Chairman of China National Pharmaceutical Group Resigns

On February 3, China National Pharmaceutical Group Corp. (Sinopharm) issued a public announcement stating that Gao Yuwen, the Chairman of the Board, has applied to resign from his positions as Chairman, Director, and member of relevant board committees due to work adjustments. Mr. Gao’s resignation took effect upon delivery to the Board of Directors. Since then, he has no longer held any position within the company. Sinopharm will complete the election of new directors and the Chairman in accordance with legal procedures as soon as possible. (Sai Bailan)

Horizon Plans to Acquire Viela Bio

Today, Horizon Therapeutics and Viela Bio announced that they have reached an agreement under which Horizon will acquire Viela Bio for approximately $3.05 billion. Through this acquisition, Horizon will gain Uplizna, Viela Bio’s approved anti-CD19 monoclonal antibody for the treatment of neuromyelitis optica spectrum disorder (NMOSD). (WuXi AppTec)

WuXi STA Announces Acquisition of Bristol Myers Squibb’s Couvet Manufacturing Site in Switzerland

On February 2, Bristol Myers Squibb and WuXi AppTec’s subsidiary, WuXi STA, jointly announced that WuXi STA would acquire Bristol Myers Squibb’s manufacturing site in Couvet, Switzerland. Upon completion of the acquisition, the Couvet facility will become WuXi STA’s first production base in Europe, further expanding its platform capabilities and scale. (WuXi AppTec)

Part 3 Pharmaceutical News and Medical Updates

TYK2 Allosteric Inhibitor Achieves Phase 3 Clinical Endpoints in the Treatment of Psoriasis

Bristol Myers Squibb Announces That Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor Deucravacitinib Met Primary Endpoint in Second Pivotal Phase 3 Trial in Patients with Moderate-to-Severe Plaque Psoriasis, Significantly Increasing the Proportion of Patients Achieving PASI 75 and Clear or Almost Clear Skin Compared with Placebo (WuXi AppTec)

Interim Results of Phase III Clinical Trials of Russian COVID-19 Vaccine Released

On February 3, the prestigious medical journal The Lancet published interim results from the Phase 3 clinical trial of Sputnik V, a COVID-19 vaccine developed in Russia. Based on data accumulated from 78 confirmed COVID-19 cases among 19,866 participants, Sputnik V demonstrated an efficacy of 91.6% in preventing COVID-19. Further analysis also showed that the vaccine’s protective efficacy in adults aged 60 years and older reached 91.8%. (WuXi AppTec)

JAMA Subjournal: Significant Results from Phase 2 Trial of Innovative Weight-Loss Drug

Recently, JAMA Network Open, a subsidiary journal of The Journal of the American Medical Association (JAMA), published promising results from a Phase 2 clinical trial of bimagrumab, an investigational innovative drug. Compared with the placebo group, the drug significantly reduced total body fat and increased lean body mass in patients with type 2 diabetes and obesity, without reducing caloric intake, while also improving blood glucose levels. (Medical New Perspectives)

Publication of Phase I Clinical Results for Clover Biopharmaceuticals’ Protein Subunit Vaccine

Recently, The Lancet published the interim analysis results of the Phase I clinical trial of Clover Biopharmaceuticals’ “S-Trimer” recombinant subunit COVID-19 candidate vaccine in an “online first” format. The results indicated that the candidate vaccine could induce high levels of neutralizing antibodies and demonstrated good safety and tolerability. (New Perspectives in Medicine)

US FDA Approves Expanded Indication for New Parkinson’s Disease Drug

Today, Adamas Pharmaceuticals announced that the U.S. FDA has approved the supplemental new drug application for Gocovri extended-release capsules as an adjunctive therapy to levodopa/carbidopa for the treatment of “off” episodes in patients with Parkinson’s disease. (WuXi AppTec)

Wuwei Biotech’s “Artemisia annua Pollen Allergen Sublingual Drops” Approved for Market Launch

On February 2, Zhejiang Wolwo Bio-Pharmaceutical’s “Artemisia annua Pollen Allergen Sublingual Drops” received approval from the NMPA. This product is an allergen extract indicated for specific immunotherapy in adult patients with allergic rhinitis caused by Artemisia annua/mugwort pollen allergy, as confirmed by allergen testing. (Insight Database)

Innovent Biologics and Eli Lilly Announce NMPA Approval of Tyvyt

Innovent Biologics and Eli Lilly and Company jointly announced today that Tyvyt (sintilimab), an innovative PD-1 inhibitor co-developed by the two companies, has officially received approval from the National Medical Products Administration (NMPA) for use in combination with pemetrexed and platinum-based chemotherapy as a first-line treatment for non-squamous non-small cell lung cancer (NSCLC). This marks the second approved indication for Tyvyt. (PR Newswire)

Bayer's Novalgo Approved in China

Bayer Announces NMPA Approval of Oral Next-Generation Androgen Receptor Inhibitor Nubeqa for the Treatment of Adult Patients with Non-Metastatic Castration-Resistant Prostate Cancer at High Risk of Metastasis. The Phase III ARAMIS study and its final analysis demonstrated that Nubeqa combined with androgen deprivation therapy (ADT) significantly improved overall survival and metastasis-free survival compared with placebo plus ADT, with a reliable safety profile. (Bayer Announcement)

Clinical Urgency: PDE4 Inhibitors Submitted for Market Approval in China

On February 3, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) announced in its latest public notice that the new drug application (NDA) for apremilast tablets, jointly submitted by Amgen and Celgene, has been accepted. Publicly available information indicates that apremilast has been included in the first batch of overseas new drugs urgently needed for clinical use in China. It is an oral, non-biologic therapeutic agent. (Yiyao Guanlan)

Bayer’s Application for Marketing Approval of Innovative Therapy Accepted by CDE

On February 3, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released its latest public notice, announcing that it had accepted Bayer’s marketing application in China for finerenone film-coated tablets, an innovative therapy. Publicly available information indicates that finerenone is a potential first-in-class non-steroidal selective mineralocorticoid receptor antagonist. (Yiyao Guanlan)