YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 396 drug applications between 31 December 2024 and 6 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 130, covering 92 drug names.
2024/12/31 – 2025/01/06
- New acceptances this week
- 396
- Drugs with new generic filings (by drug name, de-duplicated)
- 92
- Accepted this week, now under review
- 12
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
396filings, 130 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 174 |
| Generic | 130 |
| New drug | 67 |
| Import | 16 |
| Unspecified | 6 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 282 |
| TCM | 57 |
| Therapeutic biologic | 50 |
| Prophylactic biologic | 7 |
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
92 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 5 | 3 | 60 |
| 2 | Tacrolimus Ointment | 4 | 2 | 6 |
| 3 | Lidocaine and Prilocaine Cream | 3 | 2 | 24 |
| 4 | Mivacurium Chloride Injection | 3 | 2 | 3 |
| 5 | Tadalafil Tablets | 3 | 1 | 23 |
| 6 | Topiroxostat Tablets | 3 | 1 | 0 |
| 7 | Paliperidone Palmitate Injection | 3 | 1 | 8 |
| 8 | Lactulose Oral Solution | 2 | 2 | 34 |
| 9 | Fusidic Acid Cream | 2 | 2 | 15 |
| 10 | Formoterol Fumarate Inhalation Solution | 2 | 2 | 5 |
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
254 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Pfizer Europe MA EEIG | 7 | 3 | 0 |
| 2 | Shaanxi Bu Zhang Pharmaceutical Co., Ltd. romanized | 7 | 3 | 0 |
| 3 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 6 | 5 | 0 |
| 4 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 5 | 4 | 5 |
| 5 | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 5 | 2 | 0 |
| 6 | Nei Menggu Da Tang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Jin Hong Pharma Co., Ltd. romanized | 4 | 2 | 1 |
| 8 | GlaxoSmithKline Trading Services Limited | 4 | 1 | 0 |
| 9 | Guangdong Xiang Shan Tang Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized | 3 | 3 | 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
120 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/01/06Generic · Class 3 | Bilastine Oral SolutionCYHS2500069 | Xizang Ao Si Bi Xiu Pharmaceuticals Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized |
| 2025/01/06Generic · Class 3 | Promethazine Hydrochloride InjectionCYHS2500068 | Shijiazhuang Rong Wu Di Pharmaceuticals Technology Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized |
| 2025/01/06Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2500067 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2025/01/06Generic · Class 3 | 盐酸纳美芬注射液 · No verified English nameCYHS2404437 | Nanjing Hai Jing Pharma Co., Ltd. romanized |
| 2025/01/06New drug · Class 2.2 | 康柏西普眼用注射液 · No verified English nameCXSS2500001 | Chengdu Kang Hong Bio Technology Co., Ltd. romanized |
| 2025/01/06New drug · Class 1 | MNO-863肠溶胶囊 · No verified English nameCXSL2500011 | Mu En (Guangzhou) Bio Technology Co., Ltd. romanized |
| 2025/01/06New drug · Class 1 | MNO-863肠溶胶囊 · No verified English nameCXSL2500010 | Mu En (Guangzhou) Bio Technology Co., Ltd. romanized |
| 2025/01/06New drug · Class 1 | MNO-863肠溶胶囊 · No verified English nameCXSL2500009 | Mu En (Guangzhou) Bio Technology Co., Ltd. romanized |
| 2025/01/06New drug · Class 1 | SIR2501片 · No verified English nameCXHL2500009 | Wei Tai Rui Long (Beijing) Bio Technology Co., Ltd. romanized |
| 2025/01/06New drug · Class 1 | SIR2501片 · No verified English nameCXHL2500008 | Wei Tai Rui Long (Beijing) Bio Technology Co., Ltd. romanized |
| 2025/01/04Import · Class 1 | 德莫奇单抗注射液 · No verified English nameJXSS2500002 | GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Limited trading as Glaxo Wellcome Operations; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2025/01/04Import · Class 1 | 德莫奇单抗注射液 · No verified English nameJXSS2500001 | GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Limited trading as Glaxo Wellcome Operations; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2025/01/04Import · Class 1 | VG901注射液 · No verified English nameJXSL2500003 | ViGeneron GmbH; WuXi Clinical Development Services(Shanghai) Co. Ltd |
| 2025/01/04Generic · Class 3 | Benazepril Hydrochloride and Hydrochlorothiazide TabletsCYHS2500058 | Anhui Jia He Pharma Co., Ltd. romanized |
| 2025/01/04Generic · Class 3 | Potassium Aspartate And Magnesium Aspartate InjectionCYHS2500049 | Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized |
| 2025/01/04Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2500046 | Jiangxi Yi You Pharma Co., Ltd. romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized |
| 2025/01/04Generic · Class 3 | Pentoxifylline Modified Release TabletsCYHS2500044 | Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2025/01/04Generic · Class 3 | Calcitriol Oral SolutionCYHS2500040 | Henan Tai Feng Bio Technology Co., Ltd. romanized |
| 2025/01/04Generic · Class 3 | Indocyaninegreen for InjectionCYHS2500039 | Tianjin Tian Shi Li Zhi Jiao Pharma Co., Ltd. romanized |
| 2025/01/04New drug · Class 1 | HLX79 注射液 · No verified English nameCXSL2500008 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized |
| 2025/01/04New drug · Class 1.3 | 三价流感病毒裂解疫苗(ZFA02佐剂) · No verified English nameCXSL2500007 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2025/01/04New drug · Class 2.2 | 苯扎溴铵无菌溶液 · No verified English nameCXHS2500002 | Guangdong Mai Heng Pharmaceuticals Research and Development Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized |
| 2025/01/04New drug · Class 2.2 | 苯扎溴铵无菌溶液 · No verified English nameCXHS2500001 | Guangdong Mai Heng Pharmaceuticals Research and Development Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized |
| 2025/01/04New drug · Class 2.2 | JC005 · No verified English nameCXHL2500007 | Beijing Jia Cheng Biopharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2025/01/03Import · Class 1 | ABBV-400注射用粉末 · No verified English nameJXSL2500002 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/01/03Import · Class 1 | 注射用Budigalimab · No verified English nameJXSL2500001 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/01/03Import · Class 1 | STX-241片 · No verified English nameJXHL2500003 | Pierre Fabre Médicament; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd. |
| 2025/01/03Import · Class 1 | STX-241片 · No verified English nameJXHL2500002 | Pierre Fabre Médicament; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd. |
| 2025/01/03Import · Class 1 | STX-241片 · No verified English nameJXHL2500001 | Pierre Fabre Médicament; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd. |
| 2025/01/03Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2500037 | Changzhou Pharmaceutical Factory Co., Ltd. romanized |
90 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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