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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 343 drug applications between 17 October 2024 and 23 October 2024 (data as of 14 November 2026 06:00). Of these, generic applications numbered 91, covering 73 drug names.

2024/10/17 – 2024/10/23

Period
2024/10/17 to 2024/10/23, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
343
Drugs with new generic filings (by drug name, de-duplicated)
73
Accepted this week, now under review
2

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

343filings, 91 of them generic

By application type

Application typeFilings
Supplement151
Generic91
New drug61
Import24
Unspecified14
Import re-registration2

By drug type

Drug typeFilings
Chemical drug191
TCM70
Therapeutic biologic61
Biologic11
Prophylactic biologic10

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

73 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Bumetanide Injection3213
2匹伐他汀钙口崩片 · No verified English name310
3Bilastine Oral Solution228
4Metoclopramide Hydrochloride Injection226
5Lactulose Oral Solution2134
6Tacrolimus Sustained-release Capsules216
7Perampanel Tablets212
8Olmesartan Medoxomil Orally Disintegrating Tablets210
9Levocarnitine Oral Solution219
10Lamotrigine Extended Release Tablets210

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

220 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1010
2AstraZeneca AB740
3Eli Lilly and Company720
4Shenyang Dong Xin Pharma Co., Ltd. romanized660
5Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized660
6Shaanxi Sun Si Miao Gao Xin Pharmaceutical Co., Ltd. romanized660
7Beijing Bai Yi Wu You Technology Development Co., Ltd. romanized430
8Name not romanized430
9Bayer AG420
10MSD Merck Sharp & Dohme AG420

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

128 this week

AcceptedDrugApplicants
2024/10/23Import · Class 1 ADI-001 · No verified English nameJXSL2400202 Adicet Therapeutics Inc.; Shanghai Adicet Biotechnology Co. Ltd.
2024/10/23Import · Class 2.2 注射用Belantamab mafodotin · No verified English nameJXSL2400201 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. Limited
2024/10/23Import · Class 1 Itepekimab注射液 · No verified English nameJXSL2400200 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2024/10/23Import · Class 1 Frexalimab注射液 · No verified English nameJXSL2400199 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2024/10/23Generic · Class 3 Famotidine InjectionCYHS2403583 Shi Yao Yin Hu Pharmaceutical Co., Ltd. romanized
2024/10/23Generic · Class 3 Methocarbamol InjectionCYHS2403582 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized
2024/10/23Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2403576 Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2024/10/23Generic · Class 3 左羟丙哌嗪糖浆 · No verified English nameCYHS2403575 Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jia Heng Pharmaceutical Co., Ltd. romanized
2024/10/23Generic · Class 3 Minoxidil LinimentCYHS2403574 Xi Shi Lan (Nan Yang) Pharma Co., Ltd. romanized
2024/10/23Generic · Class 3 Minoxidil LinimentCYHS2403573 Xi Shi Lan (Nan Yang) Pharma Co., Ltd. romanized
2024/10/23Generic · Class 3 Olmesartan Medoxomil Orally Disintegrating TabletsCYHS2403569 Beijing Foyou Pharma CO.,LTD
2024/10/23Generic · Class 3 Olmesartan Medoxomil Orally Disintegrating TabletsCYHS2403568 Beijing Foyou Pharma CO.,LTD
2024/10/23Generic · Class 3 Diprophylline InjectionCYHS2403563 Shanghai He Feng Pharmaceutical Co., Ltd. romanized
2024/10/23Generic · Class 3 Bilastine Oral SolutionCYHL2400209 Shanghai Bo Zhi Yan Xin Drug Research Co., Ltd. romanized
2024/10/23Generic · Class 3 Acotiamide Hydrochloride TabletsCYHL2400208 Nanjing Healthnice Pharmaceutical Technology Co., Ltd
2024/10/23New drug · Class 1 BM230冻干制剂 · No verified English nameCXSL2400722 Suzhou Bo Ao Ming Sai Biopharmaceutical Co., Ltd. romanized
2024/10/23New drug · Class 1.3 BW-201 (Adj 1) · No verified English nameCXSL2400721 Beijing Bai Yi Wu You Technology Development Co., Ltd. romanized
2024/10/23New drug · Class 1.3 BW-201(Adj1) · No verified English nameCXSL2400720 Beijing Bai Yi Wu You Technology Development Co., Ltd. romanized
2024/10/23New drug · Class 1.3 BW-201 (Adj 2) · No verified English nameCXSL2400719 Beijing Bai Yi Wu You Technology Development Co., Ltd. romanized
2024/10/23New drug · Class 1.3 BW-201 (Adj 2) · No verified English nameCXSL2400718 Beijing Bai Yi Wu You Technology Development Co., Ltd. romanized
2024/10/23New drug · Class 1 CM313(SC)注射液 · No verified English nameCXSL2400717 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2024/10/23New drug · Class 1 康太替尼颗粒 · No verified English nameCXHS2400110 Shou Yao Holding (Beijing) Co., Ltd. romanized; Beijing SL Pharmaceutical Co., Ltd.
2024/10/23New drug · Class 1 康太替尼颗粒 · No verified English nameCXHS2400109 Shou Yao Holding (Beijing) Co., Ltd. romanized; Beijing SL Pharmaceutical Co., Ltd.
2024/10/23New drug · Class 1 VSA012注射液 · No verified English nameCXHL2401125 Wei Ya Zhen Bio Technology (Suzhou) Co., Ltd. romanized
2024/10/23New drug · Class 2.2 B0110 · No verified English nameCXHL2401124 Guangzhou Di Qi Pharmaceuticals Technology Co., Ltd. romanized
2024/10/22Import · Class 1 RO7790121注射液 · No verified English nameJXSL2400198 F. Hoffmann-La Roche Ltd.
2024/10/22Generic · Class 3 Sodium Nitroprusside InjectionCYHS2403556 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2024/10/22Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2403554 Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2024/10/22Generic · Class 3 Indobufen TabletsCYHS2403553 Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized
2024/10/22Generic · Class 3 Bilastine Oral SolutionCYHS2403551 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized

98 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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