YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 438 drug applications between 6 February 2025 and 12 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 156, covering 106 drug names.
2025/02/06 – 2025/02/12
- New acceptances this week
- 438
- Drugs with new generic filings (by drug name, de-duplicated)
- 106
- Accepted this week, now under review
- 19
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
438filings, 156 of them generic
By application type
| Application type | Filings |
|---|---|
| Generic | 156 |
| Supplement | 135 |
| New drug | 98 |
| Import | 29 |
| Import re-registration | 14 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 324 |
| Therapeutic biologic | 73 |
| TCM | 34 |
| 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
106 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 9 | 6 | 60 |
| 2 | Brexpiprazole Tablets | 8 | 3 | 31 |
| 3 | Tacrolimus Capsules | 4 | 2 | 2 |
| 4 | Sodium Hyaluronate Eye Drops | 4 | 2 | 30 |
| 5 | 盐酸纳美芬注射液 · No verified English name | 3 | 2 | 1 |
| 6 | Azilsartan Medoxomil Potassium Tablets | 3 | 2 | 35 |
| 7 | Polidocanol Injection | 3 | 1 | 23 |
| 8 | Levofloxacin Eye Drops | 2 | 2 | 16 |
| 9 | Tofacitinib Citrate Extended Release tablets | 2 | 2 | 2 |
| 10 | Sacubitril Valsartan Sodium Tablets | 2 | 2 | 70 |
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
262 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 11 | 3 | 0 |
| 2 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized | 9 | 3 | 0 |
| 3 | Novartis Pharma AG | 6 | 4 | 0 |
| 4 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 6 | 4 | 3 |
| 5 | Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Sichuan Kelun Pharmaceutical Co., Ltd. | 5 | 3 | 2 |
| 7 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 5 | 3 | 5 |
| 8 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 5 | 3 | 5 |
| 9 | Novo Nordisk A/S | 5 | 1 | 0 |
| 10 | Beijing Hua Shen 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
173 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/02/12Import · Class 3.1 | 司美格鲁肽注射液 · No verified English nameJXSS2500011 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd |
| 2025/02/12Import · Class 3.1 | 司美格鲁肽注射液 · No verified English nameJXSS2500010 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd |
| 2025/02/12Import · Class 3.1 | 司美格鲁肽注射液 · No verified English nameJXSS2500009 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd |
| 2025/02/12Import · Class 3.1 | 司美格鲁肽注射液 · No verified English nameJXSS2500008 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd |
| 2025/02/12Import · Class 3.1 | 司美格鲁肽注射液 · No verified English nameJXSS2500007 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd |
| 2025/02/12Import · Class 2.1 | Mosunetuzumab Injection (Subcutaneous Injection) · No verified English nameJXSL2500024 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2025/02/12Import · Class 2.1 | Mosunetuzumab Injection (Subcutaneous Injection) · No verified English nameJXSL2500023 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2025/02/12Generic · Class 3 | Nitroglycerin InjectionCYHS2500714 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized |
| 2025/02/12Generic · Class 3 | Nitroglycerin InjectionCYHS2500713 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized |
| 2025/02/12Generic · Class 3 | Amisulpride Oral SolutionCYHS2500712 | Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Ji Cui Ji Ding Pharmaceuticals Co., Ltd. romanized |
| 2025/02/12Generic · Class 3 | Bupivacaine Hydrochloride InjectionCYHS2500708 | Jinan Dong Fang Kai Yuan Pharmaceuticals Xin Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2025/02/12Generic · Class 3 | Ornidazole InjectionCYHS2500706 | Si Huan Pharmaceuticals (Zhengzhou) Co., Ltd. romanized |
| 2025/02/12Generic · Class 3 | Ornidazole InjectionCYHS2500705 | Si Huan Pharmaceuticals (Zhengzhou) Co., Ltd. romanized |
| 2025/02/12Generic · Class 3 | Bumetanide InjectionCYHS2500702 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized |
| 2025/02/12Generic · Class 3 | Bumetanide InjectionCYHS2500701 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized |
| 2025/02/12Generic · Class 3 | Eltrombopag Lamine For Oral SuspensionCYHS2500700 | Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized |
| 2025/02/12Generic · Class 3 | 硫酸特布他林口服溶液 · No verified English nameCYHS2500699 | Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized |
| 2025/02/12Generic · Class 3 | 铜[64Cu]氧奥曲肽注射液 · No verified English nameCYHL2500038 | Jiangsu Hua Yi Technology Co., Ltd. romanized |
| 2025/02/12New drug · Class 3.1 | 当归六黄颗粒 · No verified English nameCXZS2500005 | Shandong Hong Ji Tang Pharmaceutical Group Co., Ltd. romanized |
| 2025/02/12New drug · Class 3.3 | 乌司奴单抗注射液(静脉输注) · No verified English nameCXSS2500028 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized; Jiangsu Sai Fu Shi Bio Technology Co., Ltd. romanized |
| 2025/02/12New drug · Class 1.3 | 重组人乳头瘤病毒九价疫苗(汉逊酵母)(BFA58佐剂) · No verified English nameCXSL2500139 | Jiangsu Rui Ke Bio Technology Co., Ltd. romanized; Beijing An Bai Sheng Bio Technology Co., Ltd. romanized |
| 2025/02/12New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2500138 | Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized |
| 2025/02/12New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2500137 | Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized |
| 2025/02/12New drug · Class 1 | TQB2210注射液 · No verified English nameCXSL2500136 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2025/02/12New drug · Class 2.2 | 注射用卡瑞利珠单抗 · No verified English nameCXSL2500135 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/02/12New drug · Class 1 | GZR102 · No verified English nameCXSL2500134 | Gan Li Pharma Shandong Co., Ltd. romanized |
| 2025/02/12New drug · Class 2.2 | 注射用RS202227 · No verified English nameCXHL2500194 | Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/02/12New drug · Class 1 | AHB-137注射液 · No verified English nameCXHL2500193 | Hangzhou Hao Bo Pharmaceuticals Co., Ltd. romanized |
| 2025/02/11Import · Class 2.2 | 美泊利珠单抗注射液 · No verified English nameJXSS2500006 | GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited |
| 2025/02/11Import · Class 2.2 | 美泊利珠单抗注射液 · No verified English nameJXSS2500005 | GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited |
143 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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