YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 204 drug applications between 27 April 2023 and 3 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 35, covering 26 drug names.
2023/04/27 – 2023/05/03
- New acceptances this week
- 204
- Drugs with new generic filings (by drug name, de-duplicated)
- 26
- 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
204filings, 35 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 117 |
| Generic | 35 |
| New drug | 34 |
| Import | 13 |
| Unspecified | 3 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 138 |
| TCM | 35 |
| Therapeutic biologic | 25 |
| 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
26 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Duloxetine Hydrochloride Enteric Capsules | 3 | 1 | 4 |
| 2 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 3 | Topiroxostat Tablets | 2 | 1 | 0 |
| 4 | Trifluridine and Tipiracil Hydrochloride Tablets | 2 | 1 | 0 |
| 5 | 氢化可的松缓释片 · No verified English name | 2 | 1 | 0 |
| 6 | 苯磺酸左氨氯地平片 · No verified English name | 2 | 1 | 45 |
| 7 | Norepinephrine Bitartrate Injection | 2 | 1 | 9 |
| 8 | 阿伐替尼片 · No verified English name | 2 | 1 | 0 |
| 9 | Sodium Valproate Sustained-release Tablets(I) | 1 | 1 | 1 |
| 10 | 吸入用布地奈德混悬液 · No verified English name | 1 | 1 | 7 |
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
111 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized | 30 | 17 | 0 |
| 2 | Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized | 10 | 9 | 0 |
| 3 | Guo Xin (Heilongjiang) Pharmaceutical Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | Sichuan He Li Xin Jian Pharma Co., Ltd. romanized | 6 | 4 | 0 |
| 5 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 2 | 0 |
| 6 | Janssen-Cilag AG | 4 | 1 | 0 |
| 7 | Merck Sharp & Dohme LLC | 4 | 1 | 0 |
| 8 | Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized | 3 | 1 | 0 |
| 10 | Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | 3 | 1 | 3 |
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
54 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/04/29Import · Class 1 | MK-6024注射液 · No verified English nameJXSL2300085 | Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd. |
| 2023/04/29Import · Class 1 | MK-6024注射液 · No verified English nameJXSL2300084 | Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd. |
| 2023/04/29Import · Class 1 | MK-6024注射液 · No verified English nameJXSL2300083 | Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd. |
| 2023/04/29Import · Class 1 | MK-6024注射液 · No verified English nameJXSL2300082 | Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd. |
| 2023/04/29Import · Class 1 | BBP-398胶囊 · No verified English nameJXHL2300102 | LianBio Development (HK) Limited; Shanghai LianBio Development Co. Ltd. |
| 2023/04/29Import · Class 1 | BBP-398胶囊 · No verified English nameJXHL2300101 | LianBio Development (HK) Limited; Shanghai LianBio Development Co. Ltd. |
| 2023/04/29Import · Class 1 | AMG 890 · No verified English nameJXHL2300100 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2023/04/29Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2301203 | Hainan Quan Xing Pharmaceutical Co., Ltd. romanized |
| 2023/04/29Generic · Class 3 | 头孢丙烯干混悬剂 · No verified English nameCYHS2301198 | Guangdong Heng Jian Pharmaceutical Co., Ltd. romanized |
| 2023/04/29Generic · Class 3 | Pentoxifylline InjectionCYHS2301197 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/04/29Generic · Class 3 | Mepivacaine Hydrochloride InjectionCYHS2301195 | Jinan Chen Xin Pharmaceuticals Technology Co., Ltd. romanized; CISEN PHARMACEUTICAL CO., LTD. |
| 2023/04/29New drug · Class 3.3 | 水痘减毒活疫苗 · No verified English nameCXSL2300299 | Zhong Yi An Ke Bio Technology Co., Ltd. romanized; Liaoning Mao Kang Yuan Bio Technology Co., Ltd. romanized |
| 2023/04/29New drug · Class 1 | 重组抗PEAR1人源化单克隆抗体雾化吸入溶液 · No verified English nameCXSL2300298 | Shanghai Xun Yao Bio Technology Co., Ltd. romanized |
| 2023/04/29New drug · Class 2.4 | Levoleucovorin for InjectionCXHL2300453 | Shanghai Hui Lun Pharmaceuticals Co., Ltd. romanized |
| 2023/04/29New drug · Class 2.4 | Levoleucovorin for InjectionCXHL2300452 | Shanghai Hui Lun Pharmaceuticals Co., Ltd. romanized |
| 2023/04/29New drug · Class 1 | PG-011凝胶 · No verified English nameCXHL2300451 | Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/29New drug · Class 1 | PG-011凝胶 · No verified English nameCXHL2300450 | Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/29New drug · Class 1 | BPYT-01胶囊 · No verified English nameCXHL2300449 | Bai Ji You Tang (Guangdong) Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/29New drug · Class 1 | TQB3454片 · No verified English nameCXHL2300448 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/04/29New drug · Class 1 | BPYT-01胶囊 · No verified English nameCXHL2300447 | Bai Ji You Tang (Guangdong) Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/29New drug · Class 1 | TQB3454片 · No verified English nameCXHL2300446 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/04/28Import · Class 2.2 | TV-44749 · No verified English nameJXHL2300099 | Teva Branded Pharmaceutical Products R&D Inc. |
| 2023/04/28Generic · Class 3 | 氢化可的松缓释片 · No verified English nameCYHL2300068 | Jin Yao Pharma Co., Ltd. romanized |
| 2023/04/28Generic · Class 3 | 氢化可的松缓释片 · No verified English nameCYHL2300067 | Jin Yao Pharma Co., Ltd. romanized |
| 2023/04/28New drug · Class 3.1 | 芍药甘草颗粒 · No verified English nameCXZS2300010 | Shen Wei Pharma Group Co., Ltd. romanized |
| 2023/04/28New drug · Class 1 | SNP201注射液 · No verified English nameCXSL2300297 | Sai Shen (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/28New drug · Class 2.2 | 注射用重组改构人肿瘤坏死因子 · No verified English nameCXSL2300296 | Shanghai Wei Ke Biopharmaceutical Co., Ltd. romanized |
| 2023/04/28New drug · Class 1 | JY016注射液 · No verified English nameCXSL2300295 | Beijing Dong Fang Bai Tai Bio Technology Co., Ltd. romanized; Beijing Jing Yi Tai Xiang Technology Development Co., Ltd. romanized |
| 2023/04/28New drug · Class 1 | VGM-R02b · No verified English nameCXSL2300294 | Shanghai Tian Ze Yun Tai Biopharmaceuticals Co., Ltd. romanized |
| 2023/04/28New drug · Class 1 | QB0208-1胶囊 · No verified English nameCXHL2300445 | Beijing Qing Bo Hui Neng Pharmaceuticals Technology Co., Ltd. romanized |
24 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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