YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 260 drug applications between 2 June 2025 and 8 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 75, covering 50 drug names.
2025/06/02 – 2025/06/08
- New acceptances this week
- 260
- Drugs with new generic filings (by drug name, de-duplicated)
- 50
- Accepted this week, now under review
- 44
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
260filings, 75 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 112 |
| Generic | 75 |
| New drug | 49 |
| Import | 15 |
| Unspecified | 5 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 169 |
| Therapeutic biologic | 43 |
| TCM | 42 |
| Biologic | 3 |
| Prophylactic biologic | 3 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
50 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Safinamide Methansulfonate Tablets | 4 | 2 | 20 |
| 2 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 3 | Acetylcysteine Injection | 3 | 3 | 53 |
| 4 | Sodium Nitroprusside Injection | 3 | 2 | 15 |
| 5 | Minoxidil Liniment | 3 | 2 | 52 |
| 6 | Paliperidone Palmitate Injection | 3 | 1 | 8 |
| 7 | Sevelamer Carbonate Powder for oral suspension | 2 | 2 | 3 |
| 8 | Tadalafil Tablets | 2 | 1 | 23 |
| 9 | Folic acid injection | 2 | 1 | 1 |
| 10 | Zoledronic Acid Injection | 2 | 1 | 2 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
191 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly Nederland B.V. | 4 | 1 | 0 |
| 2 | Liaoning Hai Shen Lian Sheng Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 3 | Jiangsu An Zheng Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 4 | Guizhou De Chang Xiang Pharmaceuticals Co., Ltd. romanized | 3 | 3 | 0 |
| 5 | Merck Sharp & Dohme B.V. | 3 | 2 | 0 |
| 6 | Novartis Pharma AG | 3 | 2 | 0 |
| 7 | Shanxi Zheng Lai Pharmaceutical Co., Ltd. romanized | 3 | 2 | 0 |
| 8 | Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized | 3 | 2 | 0 |
| 9 | Li Zhu Group Li Zhu Pharmaceutical Factory romanized | 3 | 1 | 3 |
| 10 | Beijing Zhong Ke Xian Xing Medical Technology Co., Ltd. romanized | 3 | 1 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
89 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/06/07Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500073 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/07Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500072 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/07Import · Class 1 | Quabodepistat片 · No verified English nameJXHL2500130 | Otsuka Pharmaceutical Co. Ltd.; Otsuka Beijing Research Institute |
| 2025/06/07Import · Class 1 | JSB462片 · No verified English nameJXHL2500129 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/06/07Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2502023 | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized |
| 2025/06/07Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2502022 | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized |
| 2025/06/07Generic · Class 3 | Folic acid injectionCYHS2502020 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
| 2025/06/07Generic · Class 3 | Folic acid injectionCYHS2502019 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
| 2025/06/07Generic · Class 3 | Bilastine Oral SolutionCYHS2502018 | Jia Heng (Zhuhai Heng Qin) Pharmaceuticals Technology Co., Ltd. romanized; Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized |
| 2025/06/07Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2502016 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2025/06/07Generic · Class 3 | 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2500107 | Zhejiang Sha Pu Health Management Co., Ltd. romanized |
| 2025/06/07New drug · Class 1.1 | 益胃消瘀颗粒 · No verified English nameCXZL2500037 | Chongqing Shi Zhong Yao Research Institute (Chongqing Shi Zhong Yao Bo Wu Guan) romanized; Name not romanized |
| 2025/06/07New drug · Class 1.1 | 复方黄杞颗粒 · No verified English nameCXZL2500036 | Zhejiang Jiu Ru Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/06/07New drug · Class 1 | HJY-ATRQβ-001注射液 · No verified English nameCXSL2500463 | Wuhan Hua Ji Yuan Bio Technology Kai Fa Co., Ltd. romanized |
| 2025/06/07New drug · Class 3.3 | 流感病毒裂解疫苗 · No verified English nameCXSL2500460 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2025/06/07New drug · Class 3.3 | 流感病毒裂解疫苗 · No verified English nameCXSL2500459 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2025/06/07New drug · Class 1 | 注射用SSS50 · No verified English nameCXSL2500458 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/06/07New drug · Class 1 | 注射用LM-24C5 · No verified English nameCXSL2500457 | Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/06/07New drug · Class 2.4 | 赖诺普利氨氯地平片 · No verified English nameCXHS2500062 | Sichuan Shang Rui Biopharmaceuticals Co., Ltd. romanized; Sichuan Mei Da Kang Pharma Co., Ltd. romanized |
| 2025/06/07New drug · Class 1 | 注射用HTMC0769 · No verified English nameCXHL2500546 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2025/06/07New drug · Class 1 | HSK47977片 · No verified English nameCXHL2500545 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2025/06/07New drug · Class 1 | HSK47977片 · No verified English nameCXHL2500544 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2025/06/06Import · Class 1 | Clesrovimab注射液 · No verified English nameJXSS2500071 | Merck Sharp & Dohme B.V.; Patheon Manufacturing Services LLC; MSD R&D (China) Co. Ltd. |
| 2025/06/06Import · Class 1 | JSB462片 · No verified English nameJXHL2500128 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/06/06Import · Class 2.4 | 镥(177Lu)vipivotide tetraxetan注射液 · No verified English nameJXHL2500127 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/06/06Import · Class 2.2; 2.4 | TAR-210 · No verified English nameJXHL2500125 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/06/06Generic · Class 3 | Vitamin K1 InjectionCYHS2502012 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2025/06/06Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2502011 | Hebei Yi Pin Pharmaceutical Co., Ltd. romanized |
| 2025/06/06Generic · Class 3 | Sevelamer Carbonate Powder for oral suspensionCYHS2502009 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jiangxi Ke Rui Pharma Co., Ltd. romanized |
| 2025/06/06Generic · Class 3 | Acetylcysteine TabletsCYHS2502008 | Jiangxi Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized |
59 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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