YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 255 drug applications between 26 October 2022 and 1 November 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 38 drug names.
2022/10/26 – 2022/11/01
- New acceptances this week
- 255
- Drugs with new generic filings (by drug name, de-duplicated)
- 38
- 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
255filings, 48 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 119 |
| Generic | 48 |
| New drug | 35 |
| Import | 21 |
| Unspecified | 16 |
| Import re-registration | 16 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 195 |
| Therapeutic biologic | 31 |
| TCM | 19 |
| Biologic | 7 |
| Prophylactic biologic | 3 |
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
38 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ibuprofen Injection | 2 | 2 | 8 |
| 2 | Metaraminol Tartrate Injection | 2 | 2 | 2 |
| 3 | Olaparib Tablets | 2 | 1 | 0 |
| 4 | Flumazenil Injection | 2 | 1 | 2 |
| 5 | Urapidil Hydrochloride Injection | 2 | 1 | 6 |
| 6 | Ambroxol Hydrochloride Drops | 2 | 1 | 8 |
| 7 | Magnesium Sulfate Injection | 2 | 1 | 7 |
| 8 | Esomeprazole Magnesium Enteric-Coated Capsules | 2 | 1 | 4 |
| 9 | Dapagliflozin Tablets | 2 | 1 | 84 |
| 10 | Norepinephrine Bitartrate Injection | 2 | 1 | 9 |
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
146 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized | 12 | 11 | 0 |
| 2 | Hubei Mei Lin Pharma Co., Ltd. romanized | 9 | 6 | 0 |
| 3 | Novo Nordisk A/S | 9 | 1 | 0 |
| 4 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Shandong Han Fang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Anhui Mei Yu Pharmaceutical Co., Ltd. romanized | 5 | 3 | 0 |
| 7 | Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 8 | Hong Jian Pharmaceutical (Shanghai) Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | AstraZeneca UK Limited | 4 | 1 | 0 |
| 10 | Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized | 4 | 1 | 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
84 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/11/01Import · Class 1 | BION-1301注射液 · No verified English nameJXSL2200190 | Chinook Therapeutics Inc.; SanReno Therapeutics (Shanghai) Limited |
| 2022/11/01Import · Class 1 | KarXT胶囊 · No verified English nameJXHL2200323 | Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2022/11/01Import · Class 1 | KarXT胶囊 · No verified English nameJXHL2200322 | Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2022/11/01Import · Class 1 | KarXT胶囊 · No verified English nameJXHL2200321 | Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2022/11/01Import · Class 1 | AZD2693注射液 · No verified English nameJXHL2200320 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/11/01Import · Class 1 | AZD2693注射液 · No verified English nameJXHL2200319 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/11/01Generic · Class 3 | Fluconazole TabletsCYHS2201872 | Shandong Fang Ming Pharma Group Co., Ltd. romanized |
| 2022/11/01Generic · Class 3 | Doxofylline GranulesCYHS2201871 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/11/01Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2201868 | Le Pu Pharma Co., Ltd. romanized |
| 2022/11/01Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2201867 | Le Pu Pharma Co., Ltd. romanized |
| 2022/11/01Generic · Class 3 | Dobutamine Hydrochloride InjectionCYHS2201866 | Chengdu Giantech Hi-technology Development Co., Ltd.; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized |
| 2022/11/01Generic · Class 3 | Pentoxifylline InjectionCYHS2201865 | Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized |
| 2022/11/01Generic · Class 3 | Raltitrexed for InjectionCYHS2201863 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2022/11/01Generic · Class 3 | Ibuprofen InjectionCYHS2201861 | Shandong Luo Xin Pharma Group Co., Ltd. romanized |
| 2022/11/01New drug · Class 1 | 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2200551 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2022/11/01New drug · Class 1 | QL1706注射液 · No verified English nameCXSL2200550 | Qilu Pharmaceutical Co., Ltd. |
| 2022/11/01New drug · Class 1 | GS1191-0445注射液 · No verified English nameCXSL2200549 | Suzhou Hua Yi Le Jian Bio Technology Co., Ltd. romanized |
| 2022/11/01New drug · Class 1 | LQ043H单域抗体雾化液 · No verified English nameCXSL2200548 | Shanghai Luo Qi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/11/01New drug · Class 2.2 | 葡萄糖口服溶液 · No verified English nameCXHL2200857 | Guo Ren Health Pharmaceutical (Beijing) Co., Ltd. romanized |
| 2022/11/01New drug · Class 1 | APG-2575片 · No verified English nameCXHL2200856 | Suzhou Ya Sheng Pharma Co., Ltd. romanized |
| 2022/11/01New drug · Class 1 | APG-2575片 · No verified English nameCXHL2200855 | Suzhou Ya Sheng Pharma Co., Ltd. romanized |
| 2022/11/01New drug · Class 1 | ECC4703胶囊 · No verified English nameCXHL2200854 | Shanghai Cheng Yi Bio Technology Co., Ltd. romanized |
| 2022/11/01New drug · Class 1 | ECC4703胶囊 · No verified English nameCXHL2200853 | Shanghai Cheng Yi Bio Technology Co., Ltd. romanized |
| 2022/11/01New drug · Class 1 | ECC4703胶囊 · No verified English nameCXHL2200852 | Shanghai Cheng Yi Bio Technology Co., Ltd. romanized |
| 2022/11/01New drug · Class 2.2 | SBK010口服溶液 · No verified English nameCXHL2200851 | Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/11/01New drug · Class 1 | ABSK021胶囊 · No verified English nameCXHL2200850 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/11/01New drug · Class 1 | ABSK021胶囊 · No verified English nameCXHL2200849 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/11/01New drug · Class 1 | ABSK021胶囊 · No verified English nameCXHL2200848 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/11/01New drug · Class 1 | 注射用HRS-8427 · No verified English nameCXHL2200847 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2022/10/29Import · Class 1 | VAY736注射液 · No verified English nameJXSL2200189 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
54 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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