YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 142 drug applications between 29 April 2023 and 5 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 21, covering 19 drug names.
2023/04/29 – 2023/05/05
- New acceptances this week
- 142
- Drugs with new generic filings (by drug name, de-duplicated)
- 19
- 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
142filings, 21 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 84 |
| New drug | 23 |
| Generic | 21 |
| Import | 8 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 93 |
| TCM | 26 |
| Therapeutic biologic | 22 |
| Prophylactic biologic | 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
19 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 2 | Amikacin Sulfate injection | 2 | 1 | 4 |
| 3 | Tadalafil Tablets | 1 | 1 | 23 |
| 4 | Indobufen Tablets | 1 | 1 | 6 |
| 5 | 吸入用布地奈德混悬液 · No verified English name | 1 | 1 | 7 |
| 6 | 头孢丙烯干混悬剂 · No verified English name | 1 | 1 | 2 |
| 7 | Levetiracetam Oral Solution | 1 | 1 | 3 |
| 8 | Pentoxifylline Injection | 1 | 1 | 3 |
| 9 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 1 | 1 | 23 |
| 10 | Roxatidine Acetate Hydrochloride For Injection | 1 | 1 | 5 |
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
78 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized | 20 | 10 | 0 |
| 2 | Sichuan He Li Xin Jian Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 3 | Shaanxi Qing Hua Zi Guang Bio Technology Co., Ltd. romanized | 4 | 4 | 0 |
| 4 | Janssen-Cilag AG | 4 | 1 | 0 |
| 5 | McNeil Sweden AB | 4 | 1 | 0 |
| 6 | Merck Sharp & Dohme LLC | 4 | 1 | 0 |
| 7 | Ha Yao Group Pharmaceutical Factory romanized | 4 | 1 | 0 |
| 8 | Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | Heilongjiang Jia Yue Ze Medical Technology Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Suzhou Hong Sen Pharma Co., Ltd. romanized | 3 | 2 | 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
40 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/05/05Generic · Class 3 | Indobufen TabletsCYHS2301213 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/05/05Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2301212 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2023/05/05Generic · Class 3 | Amikacin Sulfate injectionCYHS2301211 | Shaanxi Li Cai Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2023/05/05Generic · Class 3 | Amikacin Sulfate injectionCYHS2301210 | Shaanxi Li Cai Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2023/05/05Generic · Class 3 | Azilsartan and Amlodipine TabletsCYHL2300069 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2023/05/05New drug · Class 1 | 注射用IBD0333 · No verified English nameCXSL2300306 | Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized |
| 2023/05/05New drug · Class 1 | QL1706注射液 · No verified English nameCXSL2300305 | Qilu Pharmaceutical Co., Ltd. |
| 2023/05/05New drug · Class 1 | LM103注射液 · No verified English nameCXSL2300304 | Suzhou Lan Ma Medical Technology Co., Ltd. romanized |
| 2023/05/05New drug · Class 1 | IBI354 · No verified English nameCXSL2300303 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2023/05/05New drug · Class 1 | TST001注射液 · No verified English nameCXSL2300302 | Suzhou Chuang Sheng Pharmaceuticals Group Co., Ltd. romanized |
| 2023/05/05New drug · Class 1 | HS329片 · No verified English nameCXHL2300459 | Zhejiang Hai Zheng Pharma Co., Ltd. romanized |
| 2023/05/05New drug · Class 1 | HS329片 · No verified English nameCXHL2300458 | Zhejiang Hai Zheng Pharma Co., Ltd. romanized |
| 2023/05/05New drug · Class 1 | JMKX000197注射液 · No verified English nameCXHL2300457 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2023/05/05New drug · Class 1 | JMKX000197注射液 · No verified English nameCXHL2300456 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2023/05/04Generic · Class 3 | 维生素D口服溶液 · No verified English nameCYHS2301206 | Guangzhou Lang Sheng Pharma Co., Ltd. romanized |
| 2023/05/04New drug · Class 3.3 | 德谷门冬双胰岛素注射液 · No verified English nameCXSL2300301 | Chongqing Chen An Biopharmaceutical Co., Ltd. romanized |
| 2023/05/04New drug · Class 3.3 | 德谷门冬双胰岛素注射液 · No verified English nameCXSL2300300 | Chongqing Chen An Biopharmaceutical Co., Ltd. romanized |
| 2023/05/04New drug · Class 1 | ISM3091胶囊 · No verified English nameCXHL2300455 | Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized |
| 2023/05/04New drug · Class 1 | ISM3091胶囊 · No verified English nameCXHL2300454 | Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized |
| 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. |
10 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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