YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 379 drug applications between 7 March 2025 and 13 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 109, covering 77 drug names.

2025/03/07 – 2025/03/13

Period
2025/03/07 to 2025/03/13, 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
379
Drugs with new generic filings (by drug name, de-duplicated)
77
Accepted this week, now under review
14

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

379filings, 109 of them generic

By application type

Application typeFilings
Supplement168
Generic109
New drug47
Import re-registration25
Unspecified15
Import15

By drug type

Drug typeFilings
Chemical drug307
Therapeutic biologic34
TCM31
Prophylactic biologic7

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

77 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets7370
2Brexpiprazole Tablets5231
3地氯雷他定口服溶液 · No verified English name4226
4Mivacurium Chloride Injection423
5Levofloxacin and Sodium Chloride Injection3114
6Bisoprolol Fumarate and Amlodipine Besylate Tablets229
7Glucosamine Sulfate Capsules2251
8Acipimox Capsules222
9Multiple Vitamins Injection214
10甲氧氯普胺片 · No verified English name213

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

214 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nan Yang Pu Kang Heng Wang Pharma Co., Ltd. romanized18171
2Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized17170
3Bracco Imaging S.P.A.1310
4Fresenius Kabi Deutschland GmbH1220
5Bayer AG630
6Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized510
7Hubei Wu Shi Pharma Co., Ltd. romanized434
8Qilu Pharmaceutical Co., Ltd.430
9Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized420
10Bayer Vital GmbH410

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

91 this week

AcceptedDrugApplicants
2025/03/13Import · Class 3.1 注射用维替索妥尤单抗 · No verified English nameJXSS2500023 Seagen Inc.; Baxter Oncology GmbH; Zai Lab(Shanghai) Co. Ltd
2025/03/13Import · Class 1 MK-7240注射液 · No verified English nameJXSL2500037 Merck Sharp & Dohme LLC; Name not romanized
2025/03/13Import · Class 1 SAR441566 · No verified English nameJXHL2500042 Sanofi-Aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd.
2025/03/13Import · Class 1 LY3549492片 · No verified English nameJXHL2500041 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/13Import · Class 1 LY3549492片 · No verified English nameJXHL2500040 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/13Import · Class 1 LY3549492片 · No verified English nameJXHL2500039 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/13Import · Class 1 LY3549492片 · No verified English nameJXHL2500038 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/13Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2501047 Anhui Chang Jiang Pharma Co., Ltd. romanized
2025/03/13Generic · Class 3 Sodium Thiosulfate InjectionCYHS2501043 Chengdu Yao Yi Li Kang Pharmaceuticals Technology Co., Ltd. romanized; Zhong Yu Pharmaceutical (Haikou) Co., Ltd. romanized
2025/03/13Generic · Class 3 Furosemide TabletsCYHS2501040 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/03/13Generic · Class 3 盐酸舍曲林口服浓缩液 · No verified English nameCYHS2501039 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2025/03/13Generic · Class 3 碘解磷定注射液 · No verified English nameCYHS2501036 Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized
2025/03/13Generic · Class 3 Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2501035 Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized
2025/03/13Generic · Class 3 盐酸甲氧氯普胺口服溶液 · No verified English nameCYHS2501032 Shanghai Hai Hong Industrial (Group) Chao Hu Jin Chen Pharma Co., Ltd. romanized
2025/03/13Generic · Class 3 注射用醋酸亮丙瑞林混悬液 · No verified English nameCYHL2500060 Suzhou Shan Wan Biopharmaceuticals Technology Co., Ltd. romanized
2025/03/13New drug · Class 3.3 戈利木单抗注射液 · No verified English nameCXSS2500036 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2025/03/13New drug · Class 3.3 冻干人用狂犬病疫苗(Vero细胞) · No verified English nameCXSS2500035 Shanghai Rong Sheng Bio Pharma Co., Ltd. romanized
2025/03/13New drug · Class 1 EMB-01注射液 · No verified English nameCXSL2500222 Shanghai An Mai Bio Technology Co., Ltd. romanized
2025/03/13New drug · Class 1 FWD1802片 · No verified English nameCXHL2500277 Shenzhen Fu Wo Pharma Co., Ltd. romanized
2025/03/13New drug · Class 1 FWD1802片 · No verified English nameCXHL2500276 Shenzhen Fu Wo Pharma Co., Ltd. romanized
2025/03/13New drug · Class 1 FWD1802片 · No verified English nameCXHL2500275 Shenzhen Fu Wo Pharma Co., Ltd. romanized
2025/03/13New drug · Class 1 注射用KH617 · No verified English nameCXHL2500274 Sichuan Hong He Bio Technology Co., Ltd. romanized
2025/03/12Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2501026 Hubei Wu Shi Pharma Co., Ltd. romanized
2025/03/12Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2501025 Hubei Wu Shi Pharma Co., Ltd. romanized
2025/03/12Generic · Class 3 Diphenhydramine Hydrochloride InjectionCYHS2501019 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2025/03/12Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2501018 Tianjin He Zhi Pharma Group Co., Ltd. romanized
2025/03/12Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2501017 Tianjin He Zhi Pharma Group Co., Ltd. romanized
2025/03/12Generic · Class 3 羧甲司坦糖浆 · No verified English nameCYHS2501016 Hefei Hua Wei Pharma Co., Ltd. romanized
2025/03/12Generic · Class 3 羧甲司坦糖浆 · No verified English nameCYHS2501015 Hefei Hua Wei Pharma Co., Ltd. romanized
2025/03/12Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2501014 Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized

61 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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