YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 361 drug applications between 29 November 2024 and 5 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 113, covering 91 drug names.
2024/11/29 – 2024/12/05
- New acceptances this week
- 361
- Drugs with new generic filings (by drug name, de-duplicated)
- 91
- Accepted this week, now under review
- 11
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
361filings, 113 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 162 |
| Generic | 113 |
| New drug | 59 |
| Import | 17 |
| Import re-registration | 5 |
| Unspecified | 4 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 254 |
| TCM | 59 |
| Therapeutic biologic | 43 |
| Prophylactic biologic | 3 |
| 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
91 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 3 | 2 | 23 |
| 2 | Oxcarbazepine Extended-release Tablets | 3 | 1 | 0 |
| 3 | Procaterol Hydrochloride Granules | 3 | 1 | 2 |
| 4 | Polymyxin B sulfate for Injection | 2 | 2 | 6 |
| 5 | Isavuconazonium Sulfate for Injection | 2 | 2 | 15 |
| 6 | Sodium Hyaluronate Eye Drops | 2 | 2 | 30 |
| 7 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 8 | Quetiapine Fumarate Extended-release Tablets | 2 | 1 | 0 |
| 9 | Budesonide Nasal Spray | 2 | 1 | 3 |
| 10 | Brexpiprazole Tablets | 2 | 1 | 31 |
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
233 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Sheng Bu Jia Tang Pharma Co., Ltd. romanized | 13 | 13 | 0 |
| 2 | The Wellcome Foundation Limited | 7 | 2 | 0 |
| 3 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 6 | 2 | 0 |
| 4 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 5 | 5 | 5 |
| 7 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 4 | 4 | 0 |
| 8 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized | 4 | 2 | 4 |
| 9 | Takeda Manufacturing Austria AG | 4 | 1 | 0 |
| 10 | Novartis Pharma AG | 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
116 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/12/05Import · Class 1 | PF-07934040片 · No verified English nameJXHL2400286 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2024/12/05Import · Class 1 | PF-07934040片 · No verified English nameJXHL2400285 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2024/12/05Import · Class 1 | PF-07934040片 · No verified English nameJXHL2400284 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2024/12/05Generic · Class 3 | 多索茶碱口服溶液 · No verified English nameCYHS2404206 | Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2024/12/05Generic · Class 3 | Sevelamer Carbonate Powder for oral suspensionCYHS2404201 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2024/12/05Generic · Class 3 | Gabexate Mesilate For InjectionCYHS2404194 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2024/12/05Generic · Class 3 | Oxcarbazepine Extended-release TabletsCYHL2400247 | Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanized |
| 2024/12/05Generic · Class 3 | Oxcarbazepine Extended-release TabletsCYHL2400246 | Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanized |
| 2024/12/05Generic · Class 3 | Oxcarbazepine Extended-release TabletsCYHL2400245 | Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanized |
| 2024/12/05New drug · Class 3.3 | 三价流感病毒亚单位疫苗 · No verified English nameCXSL2400826 | Beijing Bai Hui Bio Technology Co., Ltd. romanized; Bo Hui Biopharmaceutical Co., Ltd. romanized |
| 2024/12/05New drug · Class 1.4 | 24价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2400825 | Fu Xing An Te Jin (Chengdu) Biopharmaceutical Co., Ltd. romanized |
| 2024/12/05New drug · Class 1 | HB0056注射液 · No verified English nameCXSL2400824 | Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized; Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized |
| 2024/12/05New drug · Class 1 | 注射用SHR-A2009 · No verified English nameCXSL2400823 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/12/05New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2400822 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/12/05New drug · Class 1 | XNW5004片 · No verified English nameCXHL2401320 | Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/05New drug · Class 1 | XNW5004片 · No verified English nameCXHL2401319 | Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/05New drug · Class 1 | HRS-1301片 · No verified English nameCXHL2401318 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/05New drug · Class 1 | HRS-1301片 · No verified English nameCXHL2401317 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/05New drug · Class 1 | HRS-1301片 · No verified English nameCXHL2401316 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/04Import · Class 1 | Deucrictibant缓释片 · No verified English nameJXHL2400283 | Pharvaris Netherlands B.V.; Novotech Clinical Services (Shanghai) Co. Ltd. |
| 2024/12/04Import · Class 1 | Sepantronium Bromide注射液 · No verified English nameJXHL2400282 | Cothera Bioscience Inc.; Beijing Percans Oncology Co. Ltd. |
| 2024/12/04Generic · Class 3 | Piracetam TabletsCYHS2404192 | Hainan Quan Xing Pharmaceutical Co., Ltd. romanized |
| 2024/12/04Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2404191 | Hefei Hua Wei Pharma Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized |
| 2024/12/04Generic · Class 3 | Procaterol Hydrochloride GranulesCYHS2404186 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/12/04Generic · Class 3 | Procaterol Hydrochloride GranulesCYHS2404185 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/12/04Generic · Class 3 | Procaterol Hydrochloride GranulesCYHS2404183 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/12/04Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2404181 | Guangzhou Nan Xin Pharmaceutical Co., Ltd. romanized |
| 2024/12/04Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2404176 | Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2024/12/04Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2404175 | Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2024/12/04Generic · Class 3 | Amisulpride Oral SolutionCYHS2404171 | Guangzhou Ai Ge Bio Technology Co., Ltd. romanized; Hubei Wei Sen Pharmaceutical Co., Ltd. romanized |
86 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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