Lepu Biopharma Submits New NDA for PD-1 Inhibitor Pucotenlimab in MSI-H/dMMR Solid Tumors

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Policy Brief

Implementation Date for National Centralized Procurement in Beijing Confirmed

On the 25th, the Beijing Municipal Medical Centralized Procurement Service Center issued the 《Reminder on Relevant Work for Promoting the Implementation of the Selected Results of the Fifth National Centralized Drug Procurement》. According to Beijing's work arrangements for implementing the fifth batch of national centralized drug procurement, the procurement prices of drugs selected in this municipality under the fifth national centralized procurement will be uniformly adjusted on the procurement platform starting from 00:00 on October 30. (Beijing Municipal Medical Centralized Procurement Service Center)

Industry & Economics Observation

Huiyu Pharmaceutical Listed on STAR Market on Oct 26: On the 26th, Huiyu Pharmaceutical was officially listed on the STAR Market. The issue price was set at 38.87 RMB/share. The company originally planned to raise 1.907 billion RMB through its STAR Market IPO, but the actual gross proceeds totaled 2.472 billion RMB, with net proceeds of 2.361 billion RMB. As of today's market close, Huiyu Pharmaceutical's stock closed at 39.61 RMB, up 1.90%, with a trading value of 1.326 billion RMB, a turnover rate of 66.48%, a trading amplitude of 9.52%, and a total market capitalization of 16.779 billion RMB. (Sina Medical News) Salubris: Q3 Net Profit 155 Million RMB, Up 118.75% Year-on-Year: On the 25th, Salubris released its third-quarter report. Q3 revenue reached 811 million RMB, up 35.55% year-on-year; net profit was 155 million RMB, up 118.75% year-on-year. From January to the end of September, net profit stood at 392 million RMB, an increase of 46.53% compared to the same period last year. (Company Announcement)Puly Pharmaceutical: Q3 Net Profit 165 Million RMB, Up 30.5% Year-on-Year: On the 25th, Puly Pharmaceutical announced that in Q3 2021, the company achieved operating revenue of 514 million RMB, up 35.03% year-on-year; net profit attributable to shareholders was 165 million RMB, up 30.50% year-on-year; net profit attributable to shareholders after deducting non-recurring gains and losses was 165 million RMB, up 51.76% year-on-year; basic EPS was 0.37 RMB/share. (Company Announcement)David Medical: Q3 Net Profit 204,000 RMB, Down 99.71% Year-on-Year: On the 25th, David Medical announced that in the first three quarters of 2021, the company achieved operating revenue of 326 million RMB, up 2.89% year-on-year; net profit attributable to shareholders was 67.4196 million RMB, down 46.73% year-on-year. Specifically, in Q3 2021, the company achieved operating revenue of 124 million RMB, down 9.67% year-on-year; net profit attributable to shareholders was 204,000 RMB, down 99.71% year-on-year. (Company Announcement)Novartis Q3 Core EPS Exceeds Analyst Estimates: On the 26th, Novartis announced Q3 net sales of $13.03 billion, versus analyst estimates of $13.00 billion. Q3 core net profit was $3.83 billion, compared to estimates of $3.69 billion. Q3 core EPS was $1.71, against estimates of $1.64. (Cailian Press)Winner Medical: Q3 Net Profit 343 Million RMB, Down 83.8% Year-on-Year: On the evening of the 25th, Winner Medical released its Q3 report, showing that the company's operating revenue for the quarter alone was 1.76 billion RMB, down 67.06% year-on-year; quarterly net profit attributable to shareholders was 343 million RMB, down 83.8% year-on-year; quarterly net profit after deducting non-recurring gains and losses was 321 million RMB, down 84.76% year-on-year. (Company Announcement)

Pharmaceutical NewsMedical News

Positive Phase 3 Clinical Results for Regeneron and Sanofi's IL-4/IL-13 Inhibitor

On the 26th, Regeneron and Sanofi announced that the blockbuster IL-4/IL-13 inhibitor Dupixent met its dual primary endpoints in a second clinical trial for the treatment of eosinophilic esophagitis. Compared with placebo, Dupixent significantly improved patients' clinical symptoms and histological disease measures. Results from this Phase 3 clinical trial showed that after 24 weeks of treatment, disease symptoms in the Dupixent group decreased by 64% from baseline, compared to 41% in the placebo group; 59% of patients in the Dupixent group achieved histological remission, nearly 10 times that of the placebo group. Regarding safety, the results of this clinical trial were consistent with the safety profile demonstrated by Dupixent in its previously approved indications. (WuXi AppTec)

First-Line Treatment Extends Survival in Patients with Biliary Tract Cancer: AstraZeneca’s PD-L1 Inhibitor Combination Outperforms Standard Chemotherapy

On the 25th, AstraZeneca announced that its blockbuster PD-L1 inhibitor durvalumab, in combination with chemotherapy, met the primary endpoint in a Phase 3 clinical trial for the first-line treatment of patients with advanced biliary tract cancer. Compared with chemotherapy alone, the durvalumab combination provided patients with a statistically significant and clinically meaningful overall survival benefit. Additionally, the combination therapy significantly improved progression-free survival and overall response rate. Regarding safety, the combination regimen was well tolerated, with a safety profile similar to that of the control arm, and did not increase the discontinuation rate due to adverse events. (WuXi AppTec)

Merck's HIV Combination Therapy Meets Endpoints in Two Phase 3 Clinical Trials

On the 25th, Merck announced that the combination therapy comprising the novel nucleoside reverse transcriptase translocation inhibitor (NRTTI) islatravir and the approved non-nucleoside reverse transcriptase inhibitor (NNRTI) doravirine achieved positive top-line results in two pivotal Phase 3 trials in adult patients with HIV-1 infection. Both trials met their primary efficacy endpoints, and at Week 48, the doravirine/islatravir combination demonstrated antiviral efficacy comparable to both the ART group and the BIC/FTC/TAF group. (WuXi AppTec)

Johnson & Johnson's Stelara Succeeds in Two Trials for Crohn's Disease and Ulcerative Colitis

Recently, at the 2021 American College of Gastroenterology (ACG) Annual Scientific Meeting held in Las Vegas, Nevada, Johnson & Johnson presented positive trial results for Stelara, an interleukin-12 (IL-12) and IL-23 inhibitor, as a first-line treatment for Crohn's disease and ulcerative colitis, respectively. Results from the ulcerative colitis clinical trial indicated that Stelara is more effective as a first-line therapy than as a second- or third-line therapy. When used as first-line treatment, patients on Stelara experienced approximately 8.5 months of remission within one year, 23.1 months over three years, and 32.2 months over five years. However, when used as second-line therapy, patients experienced only about 7.9 months of remission within one year, 14.5 months over three years, and merely 17.5 months over five years. Findings from the Crohn's disease clinical trial demonstrated that patients initiating Stelara had a higher treatment persistence rate compared to those starting with adalimumab, including those who continued treatment without corticosteroids and those maintained on monotherapy. Specifically, patients who initiated Stelara instead of adalimumab exhibited a 50% higher treatment persistence rate, a 17% higher sustained efficacy rate, and a 47% higher sustained efficacy rate for corticosteroid-free monotherapy. (Sina Medical News)

Phase 3 Clinical Trial of TROP2-Targeted ADC / Merck PD-1 Antibody for First-Line Treatment of Lung Cancer Set to Launch

On the 25th, Daiichi Sankyo and AstraZeneca jointly announced a clinical trial collaboration and supply agreement with a subsidiary of Merck. Daiichi Sankyo will lead a global Phase 3 clinical trial aimed at evaluating the efficacy of datopotamab deruxtecan, a TROP2-targeted antibody-drug conjugate, in combination with Merck’s blockbuster PD-1 inhibitor Keytruda, compared with Keytruda monotherapy, as first-line treatment for patients with advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations. (WuXi AppTec)

Merck/Ridgeback Oral Drug Molnupiravir Enters Rolling Review in the EU

Recently, Merck and Ridgeback Biotherapeutics jointly announced that the European Medicines Agency (EMA) has initiated a rolling review of molnupiravir, an investigational oral antiviral drug for the treatment of adult patients with COVID-19. Merck plans to collaborate with the Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process, thereby facilitating the initiation of a formal review of the marketing authorization application. (Bioon)

FDA Grants Fast Track Designation to Novel Immunotherapy Regimen of nemvaleukin + Keytruda

Recently, Alkermes announced that the FDA has granted fast track designation to nemvaleukin alfa in combination with Merck's anti-PD-1 therapy Keytruda for the treatment of platinum-resistant ovarian cancer. (Bioon)

FDA Approves Xipere for the Treatment of Uveitis-Associated Macular Edema

Recently, Bausch + Lomb and Clearside Biomedical jointly announced that the FDA has approved Xipere for administration via suprachoroidal injection for the treatment of macular edema associated with uveitis. (Biovalley)

Lepu Biopharma Submits Application for PD-1 in New Indication: MSI-H Solid Tumors

On the 26th, the NMPA accepted the marketing application for Lepu Biopharma's PD-1 monoclonal antibody putlerlimab for the treatment of MSI-H/dMMR solid tumors. (NMPA)

Kangtai Biological's Dual-Carrier 13-Valent Pneumococcal Vaccine Receives NMPA Marketing Approval

On the 25th, Kangtai Biological announced that its independently developed 13-valent pneumococcal conjugate vaccine recently obtained the Lot Release Certificate for Biological Products from the NMPA, marking that the vaccine is now officially approved for commercial sale. (Jike Yaowen)

Boehringer Ingelheim Submits New Drug Application in China for First-in-Class Drug for Rare Psoriasis

On the 25th, Boehringer Ingelheim announced the submission of a marketing authorization application to the NMPA for its first-in-class monoclonal antibody Spesolimab, for the treatment of flares of generalized pustular psoriasis. (PharmaCube)

HEC Pharm's Insulin Glargine Nearing Marketing Approval

On the 25th, the official website of the NMPA indicated that the marketing authorization application for Dongyangguang Pharmaceutical’s Insulin Glargine Injection has entered the administrative approval stage and is expected to be approved in the coming days. Insulin Glargine Injection is a novel insulin analogue characterized by a long duration of action, a peakless plasma concentration profile, and stable blood glucose-lowering effects for patients. (NMPA)

Huabang Health's Methylprednisolone Sodium Succinate for Injection Passes Generic Drug Consistency Evaluation

On the 26th, Huapont Health announced that Methylprednisolone Sodium Succinate for Injection, a product of its wholly-owned subsidiary Huapont Pharmaceutical, has passed the generic drug consistency evaluation, and is primarily indicated for anti-inflammatory therapy, immunosuppressive therapy, hematological disorders, tumors, shock, and endocrine disorders. (Company Announcement)

Clinical Trial Application for BeiGene's BTK-Targeting Protein Degrader Accepted in China

On the 26th, the latest announcement from the CDE indicated that BeiGene's clinical trial application for BGB-16673 film-coated tablets has been submitted and accepted. Publicly available information shows that BGB-16673 is a BTK-targeted protein degrader currently undergoing a Phase 1, open-label, dose-escalation and expansion study in Australia for patients with B-cell malignancies. (CDE)

Heji Pharmaceutical's ITK Inhibitor IND Receives Clinical Trial Approval for Treatment of T-Cell Lymphoma

On the 26th, Heji Pharma announced that the clinical trial application for its oral CPI-818, the world’s first ITK inhibitor to enter clinical development, has been approved by the CDE. The drug is intended for the treatment of relapsed/refractory T-cell lymphoma. (PR Newswire)

Hengrui Pharma's Subsidiary Receives Clinical Trial Approval Notice for HRS9531 Injection

On the 26th, Hengrui Medicine announced that its subsidiary, Shengdi Medicine, received the 《Drug Clinical Trial Approval Notice》 approved and issued by the NMPA for HRS9531 Injection. Clinical trials will be initiated in the near future, with type 2 diabetes as the indication. (Company Announcement)

Clinical Trial Application for CSPC Zhongqi Pharmaceutical's SYHX2001 Tablets Accepted

On the 26th, the clinical trial application for SYHX2001 tablets, submitted by CSPC Zhongqi Pharmaceutical as a Class 1 new drug, was accepted by the CDE, marking the product's first clinical trial application in China for the treatment of hematologic malignancies. (CDE）

TCR2 and Bristol Myers Squibb Enter into Collaboration to Evaluate Cell Therapy for Mesothelin-Positive Solid Tumors

Recently, TCR2 Therapeutics announced a clinical trial collaboration agreement with Bristol Myers Squibb to conduct a Phase 2 clinical trial evaluating the novel cell therapy gavocabtagene autoleucel in combination with the anti-PD-1 therapy Opdivo and the anti-CTLA-4 therapy Yervoy for the treatment of refractory, mesothelin-expressing solid tumors. (Bioon)