YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 400 drug applications between 28 November 2024 and 4 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 117, covering 94 drug names.
2024/11/28 – 2024/12/04
- New acceptances this week
- 400
- Drugs with new generic filings (by drug name, de-duplicated)
- 94
- Accepted this week, now under review
- 12
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
400filings, 117 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 197 |
| Generic | 117 |
| New drug | 64 |
| Import | 15 |
| Unspecified | 3 |
| Import re-registration | 3 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 287 |
| TCM | 62 |
| Therapeutic biologic | 50 |
| 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
94 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 5 | 3 | 60 |
| 2 | Sacubitril Valsartan Sodium Tablets | 3 | 1 | 70 |
| 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 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 8 | Quetiapine Fumarate Extended-release Tablets | 2 | 1 | 0 |
| 9 | Brexpiprazole Tablets | 2 | 1 | 31 |
| 10 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
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
250 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 13 | 4 | 0 |
| 2 | Heilongjiang Sheng Bu Jia Tang Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 3 | The Wellcome Foundation Limited | 7 | 2 | 0 |
| 4 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 6 | 6 | 0 |
| 5 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 5 | 5 | 5 |
| 8 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized | 5 | 3 | 5 |
| 9 | Hua Zhong Pharma Co., Ltd. romanized | 5 | 2 | 3 |
| 10 | Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 5 | 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
119 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2024/12/04Generic · Class 3 | Ibuprofen and Phenylephrine Hydrochloride TabletsCYHL2400242 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized |
| 2024/12/04New drug · Class 2.3 | 恒古骨伤愈合剂 · No verified English nameCXZL2400086 | Sai Ling Pharma Technology Group Co., Ltd. romanized |
| 2024/12/04New drug · Class 2.3 | 恒古骨伤愈合剂 · No verified English nameCXZL2400085 | Sai Ling Pharma Technology Group Co., Ltd. romanized |
| 2024/12/04New drug · Class 2.3 | 恒古骨伤愈合剂 · No verified English nameCXZL2400084 | Sai Ling Pharma Technology Group Co., Ltd. romanized |
| 2024/12/04New drug · Class 1 | 重组质粒-肝细胞生长因子注射液 · No verified English nameCXSS2400137 | Wuhan Guang Gu Ren Fu Biopharmaceuticals Co., Ltd. romanized; Jiangsu Yao Hai Biopharmaceutical Co., Ltd. romanized |
| 2024/12/04New drug · Class 3.4 | 静注人免疫球蛋白(pH4) · No verified English nameCXSS2400136 | Guangdong Dan Xia Biopharmaceutical Co., Ltd. romanized |
| 2024/12/04New drug · Class 3.4 | 静注人免疫球蛋白(pH4) · No verified English nameCXSS2400135 | Guangdong Dan Xia Biopharmaceutical Co., Ltd. romanized |
| 2024/12/04New drug · Class 3.3 | 帕妥珠单抗注射液 · No verified English nameCXSS2400134 | Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized |
| 2024/12/04New drug · Class 2.2 | 依沃西单抗注射液 · No verified English nameCXSL2400821 | Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized |
| 2024/12/04New drug · Class 1 | NCR101注射液 · No verified English nameCXSL2400820 | Zhong Sheng Su Yuan (Guangzhou) Bio Technology Co., Ltd. romanized; Anhui Zhong Sheng Su Yuan Bio Technology Co., Ltd. romanized |
| 2024/12/04New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2400819 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2024/12/04New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2400818 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2024/12/04New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2400817 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2024/12/04New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2400816 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2024/12/04New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2400815 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2024/12/04New drug · Class 1 | KNT-0916片 · No verified English nameCXHL2401315 | Guangzhou Ke En Tai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/04New drug · Class 1 | KNT-0916片 · No verified English nameCXHL2401314 | Guangzhou Ke En Tai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/04New drug · Class 1 | KNT-0916片 · No verified English nameCXHL2401313 | Guangzhou Ke En Tai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/04New drug · Class 1 | 注射用H1710 · No verified English nameCXHL2401312 | Shenzhen Shi Hai Pu Rui Pharma Group Co., Ltd. romanized |
89 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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