YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 439 drug applications between 29 October 2026 and 4 November 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 43 drug names.
2026/10/29 – 2026/11/04
- New acceptances this week
- 439
- Drugs with new generic filings (by drug name, de-duplicated)
- 43
- Accepted this week, now under review
- 439
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
439filings, 60 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 216 |
| New drug | 109 |
| Generic | 60 |
| Import | 37 |
| Import re-registration | 15 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 220 |
| TCM | 134 |
| Therapeutic biologic | 78 |
| Prophylactic biologic | 5 |
| Biologic | 2 |
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
43 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 氟比洛芬凝胶贴膏 · No verified English name | 3 | 3 | 16 |
| 2 | 氧 · No verified English name | 3 | 3 | 15 |
| 3 | Vortioxetine Hydrobromide Tablets | 3 | 1 | 10 |
| 4 | Metformin Hydrochloride Extended-release Tablets | 3 | 1 | 10 |
| 5 | Polidocanol Injection | 3 | 1 | 23 |
| 6 | Emedastine Difumarate Eye Drops | 2 | 2 | 9 |
| 7 | Ezetimibe and Atorvastatin Calcium Trihydrate Tablets | 2 | 1 | 4 |
| 8 | 复方氨基酸注射液(17AA-SF) · No verified English name | 2 | 1 | 4 |
| 9 | 对乙酰氨基酚颗粒 · No verified English name | 2 | 1 | 2 |
| 10 | 帕拉米韦氯化钠注射液 · No verified English name | 2 | 1 | 17 |
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
252 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly and Company | 9 | 1 | 0 |
| 2 | Sichuan Xin Da Kang Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 3 | AstraZeneca AB | 7 | 4 | 0 |
| 4 | Fresenius Kabi AB | 7 | 2 | 0 |
| 5 | Hebei Wan Sui Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | MUNDIPHARMA GmbH | 6 | 1 | 0 |
| 8 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized | 6 | 1 | 0 |
| 9 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 10 | Amgen Inc. | 5 | 2 | 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
- Entered review this week
- 394
- Left the under-review list this week
- 397
Of these, NMPA published approval-document delivery for 175 (including 170 supplemental applications, not counted as new marketing approvals) and notification delivery for 18; the outcome of the other 204 is to be checked.
Most filings leaving review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | Novo Nordisk A/S | 15 | 2 |
| 2 | Beijing Bao Shu Tang Technology Pharma Co., Ltd. romanized | 11 | 11 |
| 3 | Xin Da Bio Technology Co., Ltd. romanized | 8 | 1 |
| 4 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 6 | 6 |
| 5 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 5 | 4 |
| 6 | Topfond Pharmaceutical Co., Ltd. | 4 | 4 |
| 7 | Hainan Ai Ke Pharmaceutical Co., Ltd. romanized | 4 | 4 |
| 8 | Jiao Zuo Fu Rui Tang Pharmaceutical Co., Ltd. romanized | 4 | 4 |
| 9 | Pfizer Europe MA EEIG | 4 | 3 |
| 10 | Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized | 4 | 2 |
Most filings entering review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | AstraZeneca AB | 10 | 5 |
| 2 | Eli Lilly and Company | 9 | 1 |
| 3 | Sichuan Xin Da Kang Pharma Co., Ltd. romanized | 7 | 7 |
| 4 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 7 | 6 |
| 5 | Fresenius Kabi AB | 7 | 2 |
| 6 | Hebei Wan Sui Pharma Co., Ltd. romanized | 6 | 6 |
| 7 | Sichuan Qi Li Pharmaceutical Co., Ltd. romanized | 6 | 5 |
| 8 | MUNDIPHARMA GmbH | 6 | 1 |
| 9 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized | 6 | 1 |
| 10 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized | 5 | 3 |
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
161 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/11/04Import · Class 1 | 卡瑞林肽司美格鲁肽注射液 · No verified English nameJXSL2600302 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2026/11/04Import · Class 1 | 卡瑞林肽司美格鲁肽注射液 · No verified English nameJXSL2600301 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2026/11/04Import · Class 1 | 卡瑞林肽司美格鲁肽注射液 · No verified English nameJXSL2600300 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2026/11/04Import · Class 1 | 卡瑞林肽司美格鲁肽注射液 · No verified English nameJXSL2600299 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2026/11/04Import · Class 1 | 卡瑞林肽司美格鲁肽注射液 · No verified English nameJXSL2600298 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2026/11/04Import · Class 1 | AMG 562 · No verified English nameJXSL2600297 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2026/11/04Import · Class 1 | AMG 562 · No verified English nameJXSL2600296 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2026/11/04Import · Class 2.2 | Nadofaragene firadenovec · No verified English nameJXSL2600295 | Ferring Pharmaceuticals A/S; Ferring Pharmaceuticals (Asia) Company Limited |
| 2026/11/04Import · Class 1 | Giredestrant胶囊 · No verified English nameJXHL2600484 | Genentech Inc.; Roche (China) Holding Ltd. |
| 2026/11/04Import · Class 2.4 | Icotrokinra片 · No verified English nameJXHL2600483 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/11/04Generic · Class 3 | Cetylpyridinium Chloride Buccal TabletsCYHS2602699 | Beijing Wo Bang Pharmaceuticals Technology Co., Ltd. romanized; Shanxi De Yuan Tang Pharma Co., Ltd. romanized |
| 2026/11/04Generic · Class 3 | 硫酸长春碱注射液 · No verified English nameCYHS2602696 | Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized |
| 2026/11/04Generic · Class 3 | Sivelestat Sodium for InjectionCYHS2602695 | Chongqing Huapont Pharmaceutical Co., Ltd. |
| 2026/11/04Generic · Class 3 | Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesCYHS2602691 | Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized |
| 2026/11/04Generic · Class 3 | Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesCYHS2602690 | Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized |
| 2026/11/04Generic · Class 3 | Tobramycin Inhalation SolutionCYHS2602688 | Jinan Jing Sheng Technology Co., Ltd. romanized; Luo Xin An Ruo Wei Ta Pharma (Chengdu) Co., Ltd. romanized |
| 2026/11/04New drug · Class 2.3 | 温经汤颗粒 · No verified English nameCXZL2600114 | China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.; Name not romanized |
| 2026/11/04New drug · Class 1.1 | 六味络痹颗粒 · No verified English nameCXZL2600113 | Zhongguo Zhong Yi Ke College Zhong Yi Lin Chuang Ji Chu Yi Xue Research Institute romanized |
| 2026/11/04New drug · Class 1 | EXP012注射液 · No verified English nameCXSL2601227 | Ai Ke Lian Bio Technology (Shanghai) Co., Ltd. romanized |
| 2026/11/04New drug · Class 1 | CC312冻干粉针剂 · No verified English nameCXSL2601226 | Hui He Bio Technology (Shanghai) Co., Ltd. romanized |
| 2026/11/04New drug · Class 1 | Claseprubart注射液 · No verified English nameCXSL2601225 | Yuan Yi Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/11/04New drug · Class 1 | Claseprubart注射液 · No verified English nameCXSL2601224 | Yuan Yi Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/11/04New drug · Class 1 | 注射用MWX301 · No verified English nameCXSL2601223 | Shanghai Min Wei Bio Technology Co., Ltd. romanized |
| 2026/11/04New drug · Class 1.2 | 大流行流感病毒mRNA疫苗 · No verified English nameCXSL2601222 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2026/11/04New drug · Class 1 | 注射用YL413 · No verified English nameCXSL2601221 | Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2026/11/04New drug · Class 1 | 注射用IMD2358 · No verified English nameCXSL2601220 | Shanghai Ying Mai De Medical Technology Co., Ltd. romanized |
| 2026/11/04New drug · Class 1 | YTS109细胞注射液 · No verified English nameCXSL2601219 | Hua Xia Ying Tai (Beijing) Bio Technology Co., Ltd. romanized; Hua Xia Ying Tai (Beijing) Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/11/04New drug · Class 1 | YZ-1638注射液 · No verified English nameCXSL2601218 | Shanghai Yue Zeng Bio Technology Co., Ltd. romanized |
| 2026/11/04New drug · Class 1 | 泽普昔替尼胶囊 · No verified English nameCXHS2600147 | Ling Ke Pharma (Zhejiang) Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized |
| 2026/11/04New drug · Class 1 | RO7840734 · No verified English nameCXHL2601369 | Luo Shi (Zhongguo) Investment Co., Ltd. romanized |
131 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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