YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 385 drug applications between 10 September 2025 and 16 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 66 drug names.
2025/09/10 – 2025/09/16
- New acceptances this week
- 385
- Drugs with new generic filings (by drug name, de-duplicated)
- 66
- Accepted this week, now under review
- 111
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
385filings, 90 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 180 |
| Generic | 90 |
| New drug | 63 |
| Import | 31 |
| Unspecified | 12 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 219 |
| Therapeutic biologic | 85 |
| TCM | 70 |
| Biologic | 8 |
| 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
66 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Loxoprofen Sodium Patches | 4 | 2 | 30 |
| 2 | Buspirone Hydrochloride Tablets | 3 | 1 | 5 |
| 3 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 4 | Loxoprofen Sodium Oral Solution | 2 | 2 | 6 |
| 5 | Lactulose Oral Solution | 2 | 1 | 34 |
| 6 | 利伐沙班颗粒 · No verified English name | 2 | 1 | 2 |
| 7 | Dexamethasone Sodium Phosphate Injection | 2 | 1 | 5 |
| 8 | Levocarnitine Injection | 2 | 1 | 4 |
| 9 | 帕拉米韦氯化钠注射液 · No verified English name | 2 | 1 | 17 |
| 10 | 注射用哌拉西林钠他唑巴坦钠/氯化钠注射液 · No verified English name | 2 | 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
227 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly and Company | 13 | 4 | 0 |
| 2 | Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized | 10 | 5 | 0 |
| 3 | Beijing Si Huan Biopharmaceutical Co., Ltd. romanized | 10 | 1 | 0 |
| 4 | AstraZeneca AB | 8 | 4 | 0 |
| 5 | Pfizer Inc. | 8 | 4 | 0 |
| 6 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 7 | 4 | 0 |
| 7 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 7 | 3 | 0 |
| 8 | Shanghai Shi Ling Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 9 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized | 6 | 1 | 0 |
| 10 | Sanofi Winthrop Industrie | 5 | 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
124 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/09/16Import · Class 3.1 | 吸附无细胞百白破灭活脊髓灰质炎乙型肝炎(重组)和b型流感嗜血杆菌(结合)联合疫苗 · No verified English nameJXSL2500179 | Sanofi Winthrop Industrie; Shenzhen Sanofi Pasteur Biological Products Co. Ltd. |
| 2025/09/16Import · Class 1 | Tarperprumig注射液 · No verified English nameJXSL2500177 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/09/16Import · Class 1 | AZD4512 · No verified English nameJXSL2500176 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/09/16Import · Class 1 | AZD4512 · No verified English nameJXSL2500175 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/09/16Import · Class 1 | Gadoquatrane 注射液 · No verified English nameJXHS2500101 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2025/09/16Import · Class 2.4 | DS-3201b片 · No verified English nameJXHL2500284 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2025/09/16Generic · Class 3 | Buspirone Hydrochloride TabletsCYHS2503423 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/09/16Generic · Class 3 | Buspirone Hydrochloride TabletsCYHS2503422 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/09/16Generic · Class 3 | Buspirone Hydrochloride TabletsCYHS2503421 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/09/16Generic · Class 3 | Calcium Acetate TabletsCYHS2503416 | Chi Feng Gu De Pharma Co., Ltd. romanized; Zhejiang Nord Pharmaceutical Co., Ltd |
| 2025/09/16Generic · Class 3 | Ketoprofen PatchesCYHL2500167 | Shanghai Zhao Hui Pharma Co., Ltd. romanized |
| 2025/09/16Generic · Class 3 | 米诺地尔泡沫剂 · No verified English nameCYHL2500166 | Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized |
| 2025/09/16New drug · Class 2.3 | 桑枝总生物碱片 · No verified English nameCXZL2500080 | Beijing Wu He Bo Ao Pharma Co., Ltd. romanized; Zhongguo Yi Xue Ke College Drug Research Institute romanized |
| 2025/09/16New drug · Class 1.1 | 玛木然其尼软膏 · No verified English nameCXZL2500079 | Zhong Ke Zhong Shan Drug Innovation Research Institute romanized; Zhongguo Ke College Xinjiang Li Hua Technology Research Institute romanized |
| 2025/09/16New drug · Class 1.1 | ZHY211贴膏 · No verified English nameCXZL2500078 | Hangzhou He Yuan Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/09/16New drug · Class 1.1 | 鼾眠颗粒 · No verified English nameCXZL2500077 | Shandong Kang Zhong Hong Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ji Chuan Pharma Group Co., Ltd. romanized |
| 2025/09/16New drug · Class 1 | LM103注射液 · No verified English nameCXSL2500796 | Suzhou Lan Ma Medical Technology Co., Ltd. romanized |
| 2025/09/16New drug · Class 1 | JMT206注射液 · No verified English nameCXSL2500795 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2025/09/16New drug · Class 1 | HRS-1358片 · No verified English nameCXHL2501010 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/09/16New drug · Class 1 | HRS-1358片 · No verified English nameCXHL2501009 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/09/13Import · Class 3.1 | 美泊利珠单抗注射液 · No verified English nameJXSS2500125 | GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited |
| 2025/09/13Import · Class 3.1 | 美泊利珠单抗注射液 · No verified English nameJXSS2500124 | GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited |
| 2025/09/13Generic · Class 3 | 利伐沙班颗粒 · No verified English nameCYHS2503404 | Shandong Innovation Drug Research and Development Co., Ltd. romanized; Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2025/09/13Generic · Class 3 | 利伐沙班颗粒 · No verified English nameCYHS2503403 | Shandong Innovation Drug Research and Development Co., Ltd. romanized; Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2025/09/13Generic · Class 3 | Phloroglucinol Orally Disintegrating TabletsCYHS2503396 | Nanjing Ling Nuo Biopharmaceuticals Technology Research Institute Co., Ltd. romanized; Yao Da Pharmaceutical Co., Ltd. romanized |
| 2025/09/13Generic · Class 3 | Netilmicin Sulfate InjectionCYHS2503394 | Fujian Sheng Fu Kang Pharma Co., Ltd. romanized; Hainan Hui Pu Sen Pharmaceuticals Bio Technology Co., Ltd. romanized |
| 2025/09/13Generic · Class 3 | Clindamycin Phosphate GelCYHS2503392 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2025/09/13Generic · Class 3 | 醋酸钠林格葡萄糖注射液(I) · No verified English nameCYHS2503391 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2025/09/13New drug · Class 1 | SHR-9539注射液 · No verified English nameCXSL2500793 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/09/13New drug · Class 1 | FB1002重组人源化单克隆抗体注射液 · No verified English nameCXSL2500792 | Fu Bei Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
94 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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