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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 345 drug applications between 9 September 2025 and 15 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 87, covering 61 drug names.

2025/09/09 – 2025/09/15

Period
2025/09/09 to 2025/09/15, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
345
Drugs with new generic filings (by drug name, de-duplicated)
61
Accepted this week, now under review
94

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

345filings, 87 of them generic

By application type

Application typeFilings
Supplement147
Generic87
New drug63
Import30
Unspecified11
Import re-registration7

By drug type

Drug typeFilings
Chemical drug213
TCM62
Therapeutic biologic61
Biologic7
Prophylactic biologic2

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

61 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Finerenone Tablets3269
2Upadacitinib Sustained-release Tablets2243
3Bilastine Tablets227
4Loxoprofen Sodium Oral Solution226
5Bromhexine Hydrochloride Oral Solution2222
6Glucosamine Sulfate Capsules2251
7Lactulose Oral Solution2134
8利伐沙班颗粒 · No verified English name212
9Dexamethasone Sodium Phosphate Injection215
10Levocarnitine Injection214

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

208 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company1340
2Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized1050
3AstraZeneca AB850
4Pfizer Inc.840
5Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized740
6Shanghai Shi Ling Pharmaceutical Co., Ltd. romanized610
7Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized520
8Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized440
9Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized440
10Shandong Lukang Pharmaceutical Co.,Ltd.434

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

121 this week

AcceptedDrugApplicants
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

91 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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