YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 390 drug applications between 29 December 2022 and 4 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 50 drug names.
2022/12/29 – 2023/01/04
- New acceptances this week
- 390
- Drugs with new generic filings (by drug name, de-duplicated)
- 50
- Accepted this week, now under review
- 0
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
390filings, 74 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 229 |
| Generic | 74 |
| New drug | 72 |
| Import | 9 |
| Unspecified | 3 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 269 |
| TCM | 79 |
| Therapeutic biologic | 36 |
| Prophylactic biologic | 4 |
| In vitro diagnostic reagent | 1 |
| Biologic | 1 |
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 | Esmolol Hydrochloride Injection | 3 | 3 | 3 |
| 2 | Clindamycin Injection | 3 | 1 | 4 |
| 3 | Remifentanil Hydrochloride for Injection | 3 | 1 | 2 |
| 4 | Gadobutrol Injection | 3 | 1 | 8 |
| 5 | Gadoteric Acid Meglumine Salt Injection | 3 | 1 | 1 |
| 6 | Pregabalin Oral Solution | 2 | 2 | 5 |
| 7 | Famotidine Injection | 2 | 2 | 8 |
| 8 | Vildagliptin Tablets | 2 | 2 | 0 |
| 9 | Sitagliptin Phosphate and Metformin Hydrochloride Tablets (II) | 2 | 2 | 3 |
| 10 | Phloroglucinol Injection | 2 | 2 | 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
173 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Lang De Pharma Co., Ltd. romanized | 32 | 16 | 0 |
| 2 | Guo Da (Heilongjiang) Pharmaceutical Technology Co., Ltd. romanized | 30 | 30 | 0 |
| 3 | Fresenius Kabi Deutschland GmbH | 24 | 2 | 0 |
| 4 | Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized | 16 | 16 | 0 |
| 5 | Qi Yuan Bio (Hangzhou) Co., Ltd. romanized | 8 | 1 | 0 |
| 6 | Jilin Te Yan Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Jiangxi Xin Zheng Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 5 | 3 | 4 |
| 9 | Xian Tang Chen Pharmaceutical Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized | 4 | 4 | 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
114 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/01/04Import · Class 1 | MEDI3506注射液 · No verified English nameJXSL2300004 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/01/04Import · Class 1 | Epcoritamab注射液 · No verified English nameJXSL2300003 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2023/01/04Import · Class 1 | Epcoritamab注射用浓溶液 · No verified English nameJXSL2300002 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2023/01/04Import · Class 2.2 | Ravulizumab注射液 · No verified English nameJXSL2300001 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/01/04Generic · Class 3 | Famotidine InjectionCYHS2300014 | Beijing Bu Lin Bio Technology Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/01/04Generic · Class 3 | Famotidine InjectionCYHS2300012 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/01/04Generic · Class 3 | Azilsartan TabletsCYHS2300009 | Zhejiang Nord Pharmaceutical Co., Ltd |
| 2023/01/04Generic · Class 3 | Pregabalin Oral SolutionCYHS2300005 | Shanghai Mei You Pharmaceutical Co., Ltd. romanized |
| 2023/01/04Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2300004 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized |
| 2023/01/04Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2300003 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized |
| 2023/01/04Generic · Class 3 | 布洛芬混悬滴剂 · No verified English nameCYHS2300001 | Tian Da Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized; Tian Da Pharma (Zhuhai) Co., Ltd. romanized |
| 2023/01/04New drug · Class 1 | HLX51 · No verified English nameCXSL2300003 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized |
| 2023/01/04New drug · Class 1 | MHB018A注射液 · No verified English nameCXSL2300002 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2023/01/04New drug · Class 1 | 注射用VDJ010 · No verified English nameCXSL2300001 | Beijing Wei De Jie Bio Technology Co., Ltd. romanized |
| 2023/01/04New drug · Class 1 | 恩替诺特片 · No verified English nameCXHS2300002 | Tai Zhou Yi Teng Jing Ang Pharma Co., Ltd. romanized |
| 2023/01/04New drug · Class 1 | 恩替诺特片 · No verified English nameCXHS2300001 | Tai Zhou Yi Teng Jing Ang Pharma Co., Ltd. romanized |
| 2023/01/04New drug · Class 2.2 | Umeclidinium Bromide And Vilanterol Trifenatate Powder for InhalationCXHL2300006 | Tianjin Jin Yao Pharma Co., Ltd. romanized |
| 2023/01/04New drug · Class 1 | HSK40118片 · No verified English nameCXHL2300005 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2023/01/04New drug · Class 1 | HSK40118片 · No verified English nameCXHL2300004 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2023/01/04New drug · Class 1 | HSK40118片 · No verified English nameCXHL2300003 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2023/01/04New drug · Class 1 | GPN00068注射液 · No verified English nameCXHL2300002 | Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized; Wuhan Wu Yao Technology Co., Ltd. romanized |
| 2023/01/03Generic · Class 3 | Fesoterodine Fumarate Prolonged-Release TabletsCYHL2300002 | CISEN PHARMACEUTICAL CO., LTD. |
| 2023/01/03Generic · Class 3 | Fesoterodine Fumarate Prolonged-Release TabletsCYHL2300001 | CISEN PHARMACEUTICAL CO., LTD. |
| 2023/01/03New drug · Class 1 | 注射用MT1009 · No verified English nameCXHL2300001 | Shaanxi Mai Ke Ao Te Technology Co., Ltd. romanized |
| 2023/01/01New drug · Class 2.1; 2.2 | 泰它西普注射液 · No verified English nameCXSL2200641 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2022/12/31Import · Class 2.4 | Ganaxolone口服混悬剂 · No verified English nameJXHL2200354 | Marinus Pharmaceuticals Inc.; Tenacia Biotechnology (Shanghai) Co. Ltd |
| 2022/12/31Generic · Class 3 | Diprophylline InjectionCYHS2202175 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2022/12/31Generic · Class 3 | Esmolol Hydrochloride InjectionCYHS2202174 | Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized |
| 2022/12/31New drug · Class 2.2; 2.3 | 淫羊藿苷元胶囊 · No verified English nameCXZL2200057 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2022/12/31New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSS2200095 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized; Bo Lin Ge Yin Ge Han Bio Pharma (Zhongguo) Co., Ltd. romanized |
84 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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