YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 362 drug applications between 7 September 2025 and 13 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 94, covering 66 drug names.
2025/09/07 – 2025/09/13
- New acceptances this week
- 362
- Drugs with new generic filings (by drug name, de-duplicated)
- 66
- Accepted this week, now under review
- 100
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
362filings, 94 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 155 |
| Generic | 94 |
| New drug | 64 |
| Import | 30 |
| Unspecified | 11 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 224 |
| TCM | 66 |
| Therapeutic biologic | 63 |
| Biologic | 7 |
| Prophylactic 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
66 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Finerenone Tablets | 3 | 2 | 69 |
| 2 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 3 | Bilastine Tablets | 2 | 2 | 7 |
| 4 | Loxoprofen Sodium Oral Solution | 2 | 2 | 6 |
| 5 | Bromhexine Hydrochloride Oral Solution | 2 | 2 | 22 |
| 6 | Netilmicin Sulfate Injection | 2 | 2 | 2 |
| 7 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 8 | Lactulose Oral Solution | 2 | 1 | 34 |
| 9 | 利伐沙班颗粒 · No verified English name | 2 | 1 | 2 |
| 10 | Dexamethasone Sodium Phosphate Injection | 2 | 1 | 5 |
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
221 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 | AstraZeneca AB | 8 | 5 | 0 |
| 4 | Pfizer Inc. | 8 | 4 | 0 |
| 5 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 7 | 4 | 0 |
| 6 | Shanghai Shi Ling Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Novo Nordisk A/S | 5 | 3 | 0 |
| 8 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 5 | 2 | 0 |
| 9 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized | 4 | 4 | 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
127 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2025/09/13New drug · Class 1 | FB1002重组人源化单克隆抗体注射液 · No verified English nameCXSL2500791 | Fu Bei Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/09/13New drug · Class 1 | HRS-3738片 · No verified English nameCXHL2501007 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/09/13New drug · Class 1 | HRS-3738片 · No verified English nameCXHL2501006 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/09/13New drug · Class 1 | HRS-6209胶囊 · No verified English nameCXHL2501005 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/09/13New drug · Class 1 | HRS-6209胶囊 · No verified English nameCXHL2501004 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/09/13New drug · Class 1 | HRS-5041片 · No verified English nameCXHL2501003 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/09/13New drug · Class 1 | HRS-5041片 · No verified English nameCXHL2501002 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/09/13New drug · Class 1 | HRS-8080片 · No verified English nameCXHL2501001 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/09/13New drug · Class 1 | HRS-8080片 · No verified English nameCXHL2501000 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/09/13New drug · Class 1 | HRS-8080片 · No verified English nameCXHL2500999 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/09/12Import · Class 2.4 | Dabrafenib mesylate CapsulesJXHS2500099 | Novartis Europharm Limited; Siegfried Barbera S.L.; Novartis Pharmaceutical Manufacturing LLC; Beijing Novartis Pharma Co. Ltd. |
| 2025/09/12Import · Class 2.4 | Dabrafenib mesylate CapsulesJXHS2500098 | Novartis Europharm Limited; Siegfried Barbera S.L.; Novartis Pharmaceutical Manufacturing LLC; Beijing Novartis Pharma Co. Ltd. |
| 2025/09/12Import · Class 2.4 | 甲苯磺酸利特昔替尼胶囊 · No verified English nameJXHL2500282 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
| 2025/09/12Import · Class 2.4 | 甲苯磺酸利特昔替尼胶囊 · No verified English nameJXHL2500281 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
| 2025/09/12Import · Class 1 | Retatrutide注射液 · No verified English nameJXHL2500280 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/12Import · Class 1 | Retatrutide注射液 · No verified English nameJXHL2500279 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/12Import · Class 1 | Retatrutide注射液 · No verified English nameJXHL2500278 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/12Import · Class 1 | Retatrutide注射液 · No verified English nameJXHL2500277 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/12Import · Class 1 | Retatrutide注射液 · No verified English nameJXHL2500276 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/12Generic · Class 3 | Lidocaine Hydrochloride GelCYHS2503390 | Beijing Zhong Tai Bang Pharmaceuticals Technology Co., Ltd. romanized |
97 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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