YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 531 drug applications between 23 September 2024 and 29 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 158, covering 108 drug names.
2024/09/23 – 2024/09/29
- New acceptances this week
- 531
- Drugs with new generic filings (by drug name, de-duplicated)
- 108
- 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
531filings, 158 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 203 |
| Generic | 158 |
| New drug | 91 |
| Import | 40 |
| Unspecified | 27 |
| Import re-registration | 11 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 338 |
| TCM | 82 |
| Therapeutic biologic | 82 |
| Biologic | 21 |
| Prophylactic biologic | 8 |
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
108 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Fentanyl Citrate Buccal Tablets | 6 | 1 | 0 |
| 2 | Cefoperazone Sodium and Sulbactam Sodium for Injection | 6 | 1 | 14 |
| 3 | Brexpiprazole Tablets | 4 | 2 | 31 |
| 4 | Polymyxin B sulfate for Injection | 3 | 3 | 6 |
| 5 | Dapagliflozin Tablets | 3 | 2 | 84 |
| 6 | Carbamazepine Sustained-Release Tablets(II) | 3 | 1 | 0 |
| 7 | Brexpiprazole Orally Disintegrating Tablets | 3 | 1 | 10 |
| 8 | Amoxicillin Sodium and Sulbactam Sodium for Injection | 3 | 1 | 7 |
| 9 | Procaterol Hydrochloride Granules | 3 | 1 | 2 |
| 10 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 3 | 1 | 2 |
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
315 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 9 | 5 | 0 |
| 2 | Amgen Inc. | 9 | 2 | 0 |
| 3 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 9 | 2 | 9 |
| 4 | AstraZeneca AB | 8 | 4 | 0 |
| 5 | Janssen-Cilag International NV | 7 | 3 | 0 |
| 6 | Guo Yao Group Kunming Xue Ye Zhi Pin Co., Ltd. romanized | 7 | 3 | 0 |
| 7 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 2 | 0 |
| 8 | Zhejiang Wo Wu Bio Technology Co., Ltd. romanized | 7 | 1 | 0 |
| 9 | Jiangxi Xing Lin Bai Ma Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 10 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized | 6 | 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
197 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/09/29Import · Class 1 | MEDI5752 · No verified English nameJXSL2400186 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/29Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2403297 | Chengdu Ya Tu Bio Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized |
| 2024/09/29New drug · Class 1 | HRS-4729注射液 · No verified English nameCXHL2401028 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/09/29New drug · Class 1 | HRS-4729注射液 · No verified English nameCXHL2401027 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/09/28Import · Class 2.4 | 英克司兰钠注射液 · No verified English nameJXHL2400240 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2024/09/28Import · Class 2.4 | 英克司兰钠注射液 · No verified English nameJXHL2400239 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2024/09/28Generic · Class 3 | Potassium Chloride GranulesCYHS2403295 | Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2024/09/28Generic · Class 3 | Nitroglycerin InjectionCYHS2403294 | Hubei Sheng He Kang Da Pharmaceuticals Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2024/09/28Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2403292 | Jinan Jing Sheng Technology Co., Ltd. romanized; Luo Xin An Ruo Wei Ta Pharma (Chengdu) Co., Ltd. romanized |
| 2024/09/28Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2403291 | Jinan Jing Sheng Technology Co., Ltd. romanized; Luo Xin An Ruo Wei Ta Pharma (Chengdu) Co., Ltd. romanized |
| 2024/09/28Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2403290 | Jinan Jing Sheng Technology Co., Ltd. romanized; Luo Xin An Ruo Wei Ta Pharma (Chengdu) Co., Ltd. romanized |
| 2024/09/28Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2403283 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2024/09/28Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2403282 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2024/09/28Generic · Class 3 | Mannitol-S InjectionCYHL2400198 | Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized |
| 2024/09/28Generic · Class 3 | Lasmiditan TabletsCYHL2400197 | Jiangxi Ke Rui Pharma Co., Ltd. romanized |
| 2024/09/28Generic · Class 3 | Lasmiditan TabletsCYHL2400196 | Jiangxi Ke Rui Pharma Co., Ltd. romanized |
| 2024/09/28New drug · Class 1.1 | 感咳颗粒 · No verified English nameCXZL2400061 | Ying Ke Rui (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized |
| 2024/09/28New drug · Class 1 | 人羊膜间充质干细胞注射液 · No verified English nameCXSL2400674 | Yuan Pin Xi Bao Bio Technology Group Co., Ltd. romanized |
| 2024/09/28New drug · Class 1 | UX-DA001注射液(人中脑多巴胺能神经前体细胞注射液) · No verified English nameCXSL2400673 | Shanghai Yue Sai Bio Technology Co., Ltd. romanized |
| 2024/09/28New drug · Class 2.4 | Dexamethasone Palmitate InjectionCXHL2401026 | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized |
| 2024/09/28New drug · Class 1 | GenSci122片 · No verified English nameCXHL2401025 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2024/09/28New drug · Class 1 | GenSci122片 · No verified English nameCXHL2401024 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2024/09/28New drug · Class 1 | GP-2102乳膏 · No verified English nameCXHL2401023 | Nanjing Ji Qun Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/28New drug · Class 1 | GP-2102乳膏 · No verified English nameCXHL2401022 | Nanjing Ji Qun Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/28New drug · Class 2.2 | 甲磺酸雷沙吉兰透皮贴剂 · No verified English nameCXHL2401021 | Guizhou Shi Ling Pharmaceutical Co., Ltd. romanized; Shanghai Shi Ling Pharmaceutical Co., Ltd. romanized |
| 2024/09/28New drug · Class 2.2 | 甲磺酸雷沙吉兰透皮贴剂 · No verified English nameCXHL2401020 | Guizhou Shi Ling Pharmaceutical Co., Ltd. romanized; Shanghai Shi Ling Pharmaceutical Co., Ltd. romanized |
| 2024/09/27Import · Class 1 | MEDI5752 · No verified English nameJXSL2400185 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/27Import · Class 1 | AZD2936 · No verified English nameJXSL2400184 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/27Import · Class 2.2 | DS-8201a · No verified English nameJXSL2400183 | AstraZeneca AB; AstraZeneca Investment (China) Co. Limited |
| 2024/09/27Import · Class 1 | 镥[177Lu]依多曲肽注射液 · No verified English nameJXHL2400238 | ITM Solucin GmbH; Grand Pharmaceutical (China) Co. Ltd. |
167 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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