YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 347 drug applications between 13 March 2025 and 19 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 83, covering 61 drug names.
2025/03/13 – 2025/03/19
- New acceptances this week
- 347
- Drugs with new generic filings (by drug name, de-duplicated)
- 61
- Accepted this week, now under review
- 22
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
347filings, 83 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 167 |
| Generic | 83 |
| New drug | 57 |
| Import | 22 |
| Unspecified | 13 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 251 |
| TCM | 47 |
| Therapeutic biologic | 43 |
| 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
61 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 4 | 2 | 70 |
| 2 | Lactulose Oral Solution | 3 | 2 | 34 |
| 3 | Riociguat Tablets | 3 | 1 | 4 |
| 4 | 腺苷钴胺胶囊 · No verified English name | 2 | 2 | 8 |
| 5 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 6 | Famotidine Injection | 2 | 1 | 8 |
| 7 | Hydrocortisone Sodium Succinate for Injection | 2 | 1 | 16 |
| 8 | Ciclosporin Soft Capsules | 2 | 1 | 2 |
| 9 | Edoxaban Tosilate Tablets | 2 | 1 | 9 |
| 10 | Lidocaine Hydrochloride Injection | 2 | 1 | 6 |
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
200 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | 8 | 8 | 0 |
| 2 | Nan Yang Pu Kang Heng Wang Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 3 | Hunan Jiudian Pharmaceutical Co., Ltd | 6 | 5 | 0 |
| 4 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 3 | 0 |
| 5 | Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | AstraZeneca AB | 5 | 3 | 0 |
| 7 | Li Bang Pharma (Shanghai) Co., Ltd. romanized | 5 | 1 | 0 |
| 8 | Guangzhou Ze Sheng Pharma Technology Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Zhongguo Ke College Shanghai Drug Research Institute romanized | 4 | 3 | 0 |
| 10 | Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized | 4 | 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
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
111 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/03/19Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2501112 | Shanghai He Feng Pharmaceutical Co., Ltd. romanized |
| 2025/03/19Generic · Class 3 | 酒石酸阿福特罗吸入溶液 · No verified English nameCYHS2501111 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2025/03/19Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2501110 | Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2025/03/19Generic · Class 3 | Phloroglucinol Orally Disintegrating TabletsCYHS2501105 | Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized |
| 2025/03/19Generic · Class 3 | 左羟丙哌嗪口服溶液 · No verified English nameCYHS2501104 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/03/19Generic · Class 3 | Gatifloxacin Eye DropsCYHS2501102 | Hefei Nuo Rui Te Pharmaceutical Co., Ltd. romanized; Anhui Sheng Shuang Ke Pharma Co., Ltd. romanized |
| 2025/03/19New drug · Class 2.3 | 松龄血脉康胶囊 · No verified English nameCXZL2500018 | Chengdu Kang Hong Pharmaceutical Co., Ltd. romanized |
| 2025/03/19New drug · Class 1 | SSS55注射液 · No verified English nameCXSL2500235 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/03/19New drug · Class 1 | VPD/FC01002 注射液 · No verified English nameCXSL2500234 | Wei Neng Sheng Ming Technology Group Co., Ltd. romanized |
| 2025/03/19New drug · Class 1 | GB18注射液 · No verified English nameCXSL2500226 | Shenzhen Ke Xing Pharma Co., Ltd. romanized |
| 2025/03/19New drug · Class 2.4 | Regadenoson InjectionCXHS2500024 | Nanjing Rui Ke Wei Biopharmaceuticals Co., Ltd. romanized; Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized |
| 2025/03/19New drug · Class 2.1; 2.2; 2.4 | 醋酸沃诺拉赞注射液 · No verified English nameCXHS2500023 | Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized; Nanjing Ke Fei Ping Sheng Hui Pharmaceutical Co., Ltd. romanized |
| 2025/03/19New drug · Class 1 | AP303片 · No verified English nameCXHL2500306 | Li Bang Pharma (Shanghai) Co., Ltd. romanized |
| 2025/03/19New drug · Class 1 | AP303片 · No verified English nameCXHL2500305 | Li Bang Pharma (Shanghai) Co., Ltd. romanized |
| 2025/03/19New drug · Class 1 | AP303片 · No verified English nameCXHL2500304 | Li Bang Pharma (Shanghai) Co., Ltd. romanized |
| 2025/03/19New drug · Class 1 | AP303片 · No verified English nameCXHL2500303 | Li Bang Pharma (Shanghai) Co., Ltd. romanized |
| 2025/03/19New drug · Class 1 | AP303片 · No verified English nameCXHL2500302 | Li Bang Pharma (Shanghai) Co., Ltd. romanized |
| 2025/03/19New drug · Class 2.2 | NS1009 · No verified English nameCXHL2500301 | Xin Ling Pharmaceuticals (Zhong Shan) Co., Ltd. romanized |
| 2025/03/18Import · Class 2.4 | 地非法林注射液 · No verified English nameJXHL2500049 | Vifor Fresenius Medical Care Renal Pharma Ltd.; Zhejiang Medical Technology Development Co. LTD. |
| 2025/03/18Import · Class 1 | VSA001注射液 · No verified English nameJXHL2500048 | Arrowhead Pharmaceuticals Inc.; Sanofi (China) Investment Co. Ltd. |
| 2025/03/18Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2501100 | Henan Li Hua Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2025/03/18Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2501099 | Henan Li Hua Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2025/03/18Generic · Class 3 | Propafenone Hydrochloride InjectionCYHS2501097 | Anhui Chang Jiang Pharma Co., Ltd. romanized |
| 2025/03/18Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2501096 | Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2025/03/18Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2501095 | Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2025/03/18Generic · Class 3 | Doxycycline Hyclate for InjectionCYHS2501092 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2025/03/18Generic · Class 3 | Labetalol Hydrochloride InjectionCYHS2501090 | Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/03/18Generic · Class 3 | Labetalol Hydrochloride InjectionCYHS2501089 | Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/03/18Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2501088 | Henan Pu Rui Pharma Co., Ltd. romanized |
| 2025/03/18Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2501087 | Henan Pu Rui Pharma Co., Ltd. romanized |
81 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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