YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 454 drug applications between 7 February 2025 and 13 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 163, covering 109 drug names.
2025/02/07 – 2025/02/13
- New acceptances this week
- 454
- Drugs with new generic filings (by drug name, de-duplicated)
- 109
- Accepted this week, now under review
- 21
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
454filings, 163 of them generic
By application type
| Application type | Filings |
|---|---|
| Generic | 163 |
| Supplement | 143 |
| New drug | 103 |
| Import | 28 |
| Import re-registration | 11 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 321 |
| Therapeutic biologic | 86 |
| TCM | 41 |
| Prophylactic biologic | 4 |
| 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
109 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 | Nitroglycerin Injection | 4 | 2 | 7 |
| 6 | Polymyxin B sulfate for Injection | 3 | 3 | 6 |
| 7 | Azilsartan Medoxomil Potassium Tablets | 3 | 2 | 35 |
| 8 | Polidocanol Injection | 3 | 1 | 23 |
| 9 | 二硫化硒洗剂 · No verified English name | 2 | 2 | 14 |
| 10 | MOVICOL Ready To Take Sachet, Powder For Oral Solution | 2 | 2 | 16 |
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
276 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized | 10 | 3 | 0 |
| 2 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 8 | 2 | 0 |
| 3 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 6 | 4 | 3 |
| 4 | Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Novartis Pharma AG | 5 | 3 | 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
191 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/02/13Import · Class 3.1 | 西妥昔单抗注射液 · No verified English nameJXSS2500012 | Merck Europe B.V.; Merck Healthcare KGaA; Merck Serono Co. Ltd. |
| 2025/02/13Import · Class 2.2 | 艾加莫德α注射液(皮下注射) · No verified English nameJXSL2500025 | argenx BV; Zai Lab (Shanghai) Co. Ltd. |
| 2025/02/13Generic · Class 3 | Erythromycin Lactobionate for InjectionCYHS2500734 | Hai Tao Xin Yao Research and Development (Jiangsu) Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2025/02/13Generic · Class 3 | Ferrous Succinate TabletsCYHS2500733 | Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/02/13Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2500732 | Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2025/02/13Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2500731 | Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2025/02/13Generic · Class 3 | Diprophylline InjectionCYHS2500730 | Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized |
| 2025/02/13Generic · Class 3 | Olprinone Hydrochloride InjectionCYHS2500729 | Shandong Jian Bin Pharmaceuticals Technology Co., Ltd. romanized; Xian Han Feng Pharma Co., Ltd. romanized |
| 2025/02/13Generic · Class 3 | Potassium Phosphates InjectionCYHS2500728 | Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/02/13Generic · Class 3 | 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2500725 | Shandong Yi Kang Pharma Co., Ltd. romanized |
| 2025/02/13Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2500724 | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized |
| 2025/02/13Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2500723 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2025/02/13Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2500722 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized |
| 2025/02/13Generic · Class 3 | 二硫化硒洗剂 · No verified English nameCYHS2500720 | Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Zhejiang Ding Tai Pharma Co., Ltd. romanized |
| 2025/02/13Generic · Class 3 | Nitroglycerin InjectionCYHS2500719 | Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2025/02/13Generic · Class 3 | Nitroglycerin InjectionCYHS2500718 | Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2025/02/13Generic · Class 3 | Bilastine Orally disintegrating TabletsCYHS2500717 | Guangdong Ren Xiang Pharma Co., Ltd. romanized; Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized |
| 2025/02/13Generic · Class 3 | Bifonazole SolutionCYHS2500716 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2025/02/13Generic · Class 3 | Topiroxostat TabletsCYHL2500040 | Changchun Hai Yue Pharma Co., Ltd. romanized |
| 2025/02/13Generic · Class 3 | Topiroxostat TabletsCYHL2500039 | Changchun Hai Yue Pharma Co., Ltd. romanized |
| 2025/02/13New drug · Class 3.1 | 真武颗粒 · No verified English nameCXZS2500007 | Kang Pu Pharma Co., Ltd. romanized |
| 2025/02/13New drug · Class 3.1 | 芍药甘草颗粒 · No verified English nameCXZS2500006 | Hubei Ji An Tang Pharma Co., Ltd. romanized |
| 2025/02/13New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2500144 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/02/13New drug · Class 1 | 注射用ESG406 · No verified English nameCXSL2500143 | Shanghai Shi Jian Bio Technology Co., Ltd. romanized |
| 2025/02/13New drug · Class 1 | 注射用XTL6001 · No verified English nameCXSL2500142 | Shanghai Xi Tai Li Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/02/13New drug · Class 1 | IAH0968 · No verified English nameCXSL2500141 | Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized |
| 2025/02/13New drug · Class 1 | 注射用BAT7111 · No verified English nameCXSL2500140 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2025/02/13New drug · Class 1 | HEC-007注射液 · No verified English nameCXHL2500199 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized |
| 2025/02/13New drug · Class 1 | HEC-007注射液 · No verified English nameCXHL2500198 | Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized; Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2025/02/13New drug · Class 1 | HEC-007注射液 · No verified English nameCXHL2500197 | Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized; Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
161 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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