YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 289 drug applications between 27 February 2023 and 5 March 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 61, covering 41 drug names.
2023/02/27 – 2023/03/05
- New acceptances this week
- 289
- Drugs with new generic filings (by drug name, de-duplicated)
- 41
- Accepted this week, now under review
- 1
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
289filings, 61 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 156 |
| Generic | 61 |
| New drug | 31 |
| Unspecified | 15 |
| Import | 15 |
| Import re-registration | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 197 |
| TCM | 57 |
| Therapeutic biologic | 25 |
| Prophylactic biologic | 6 |
| Biologic | 3 |
| In vitro diagnostic reagent | 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
41 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lactulose Oral Solution | 4 | 2 | 34 |
| 2 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 3 | Phenylephrine Hydrochloride Injection | 3 | 2 | 5 |
| 4 | Ambroxol Hydrochloride Oral Solution | 3 | 2 | 46 |
| 5 | Lidocaine and Prilocaine Cream | 2 | 2 | 24 |
| 6 | Sodium Valproate Oral Solution | 2 | 1 | 1 |
| 7 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 8 | Carbazochrome Sodium Sulfonate Injection | 2 | 1 | 1 |
| 9 | Torsemide Injection | 2 | 1 | 1 |
| 10 | Aminophylline Injection | 2 | 1 | 3 |
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
176 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 15 | 14 | 0 |
| 2 | Guangdong Song Xia Pharma Co., Ltd. romanized | 11 | 11 | 0 |
| 3 | NAPP PHARMACEUTICALS LIMITED | 9 | 1 | 0 |
| 4 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 5 | Shaanxi Nian Qing Bao Pharmaceutical Co., Ltd. romanized | 5 | 3 | 0 |
| 6 | Merck & Co. Inc. | 4 | 4 | 0 |
| 7 | Name not romanized | 4 | 3 | 4 |
| 8 | N.V. Organon | 4 | 2 | 0 |
| 9 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 4 | 2 | 4 |
| 10 | Nei Menggu Yi Li Pharmaceutical Co., Ltd. romanized | 3 | 3 | 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
74 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/03/04Import · Class 2.2 | Upadacitinib口服溶液 · No verified English nameJXHL2300042 | AbbVie Inc. |
| 2023/03/04Generic · Class 3 | 对乙酰氨基酚甘露醇注射液 · No verified English nameCYHS2300699 | Jilin Kang Nai Er Pharma Co., Ltd. romanized |
| 2023/03/04Generic · Class 3 | Ketotifen Fumarate Nasal SprayCYHS2300696 | Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2023/03/04Generic · Class 3 | Aminophylline InjectionCYHS2300685 | Beijing Bai Mei Te Biopharmaceutical Co., Ltd. romanized |
| 2023/03/04Generic · Class 3 | Aminophylline InjectionCYHS2300684 | Beijing Bai Mei Te Biopharmaceutical Co., Ltd. romanized |
| 2023/03/04New drug · Class 1.1 | 健脾益肾丸 · No verified English nameCXZL2300016 | Shenzhen Shi Zhong Hospital romanized |
| 2023/03/04New drug · Class 1 | BSI-060T注射液 · No verified English nameCXSL2300171 | Bo Ao Xin Bio Technology (Nanjing) Co., Ltd. romanized |
| 2023/03/04New drug · Class 1 | XH101注射液 · No verified English nameCXSL2300170 | Shenzhen Shi Xin He Bio Medical Technology Co., Ltd. romanized |
| 2023/03/04New drug · Class 1 | 靶向BCMA-CD19的安全型嵌合抗原受体T细胞注射液 · No verified English nameCXSL2300169 | Hunan Si Wei Kang Pharmaceuticals Co., Ltd. romanized |
| 2023/03/04New drug · Class 1 | 9MW3911注射液 · No verified English nameCXSL2300168 | Nanjing Nuo Ai Xin Bio Technology Co., Ltd. romanized |
| 2023/03/03Import · Class 3.1 | 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300020 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd. |
| 2023/03/03Import · Class 3.1 | 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300019 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd. |
| 2023/03/03Import · Class 1 | Milvexian片 · No verified English nameJXHL2300041 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/03/03Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2300680 | Guangzhou Wei Ao Kang Pharma Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2023/03/03Generic · Class 3 | Minoxidil Topical SolutionCYHS2300679 | Jinan Zhong Hai Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized |
| 2023/03/03Generic · Class 3 | Minoxidil Topical SolutionCYHS2300678 | Jinan Zhong Hai Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized |
| 2023/03/03Generic · Class 3 | Metoprolol Succinate Extended-release CapsulesCYHS2300677 | Fujian Sheng Bao Nuo Pharmaceuticals Research and Development Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2023/03/03Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2300675 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2023/03/03Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2300674 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2023/03/03Generic · Class 3 | Torsemide InjectionCYHS2300673 | Beijing Yuan Yan Pharmaceuticals Technology Co., Ltd. romanized; Xian Han Feng Pharma Co., Ltd. romanized |
| 2023/03/03Generic · Class 3 | Torsemide InjectionCYHS2300672 | Beijing Yuan Yan Pharmaceuticals Technology Co., Ltd. romanized; Xian Han Feng Pharma Co., Ltd. romanized |
| 2023/03/03New drug · Class 1 | 重组人源化抗HER2双特异性抗体注射液 · No verified English nameCXSL2300166 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2023/03/03New drug · Class 1 | BRL-186616片 · No verified English nameCXHL2300268 | Xiamen Shi Bo Rui Lai Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/03/03New drug · Class 1 | BRL-186616片 · No verified English nameCXHL2300267 | Xiamen Shi Bo Rui Lai Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/03/03New drug · Class 2.2 | 注射用阿立哌唑缓释微球 · No verified English nameCXHL2300266 | Hui Li Pharma (Suzhou) Co., Ltd. romanized |
| 2023/03/03New drug · Class 2.4 | 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2300265 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2023/03/03New drug · Class 1 | WXSH0102片 · No verified English nameCXHL2300264 | CISEN PHARMACEUTICAL CO., LTD. |
| 2023/03/03New drug · Class 1 | WXSH0102片 · No verified English nameCXHL2300263 | CISEN PHARMACEUTICAL CO., LTD. |
| 2023/03/03New drug · Class 2.4 | 奥布替尼片 · No verified English nameCXHL2300262 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/03/02Import · Class 1 | RO7200220 注射液 · No verified English nameJXSL2300047 | F. Hoffmann-La Roche Ltd. |
44 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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