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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 387 drug applications between 14 May 2025 and 20 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 104, covering 73 drug names.

2025/05/14 – 2025/05/20

Period
2025/05/14 to 2025/05/20, 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
387
Drugs with new generic filings (by drug name, de-duplicated)
73
Accepted this week, now under review
59

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

387filings, 104 of them generic

By application type

Application typeFilings
Supplement199
Generic104
New drug55
Import18
Unspecified8
Import re-registration3

By drug type

Drug typeFilings
Chemical drug259
TCM64
Therapeutic biologic58
Prophylactic biologic4
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

73 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1复方电解质醋酸钠葡萄糖注射液 · No verified English name4222
2Risperidone Oral Solution416
3Calcium Acetate Oral Solution411
4Aripiprazole Oral Solution414
5Drotaverine Hydrochloride Injection223
6Bromhexine Hydrochloride Oral Solution2222
7Metoclopramide Hydrochloride Injection226
8Glucosamine Sulfate Capsules2251
9维生素B12注射液 · No verified English name226
10Oxcarbazepine Tablets214

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

234 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized13413
2Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized760
3AstraZeneca AB740
4Qilu Pharmaceutical Co., Ltd.730
5Hong Tao Kai Pharma Co., Ltd. romanized660
6Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized520
7CISEN PHARMACEUTICAL CO., LTD.521
8Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized510
9Xizang Ao Si Bi Xiu Pharmaceuticals Co., Ltd. romanized510
10Hainan Hai Li Pharmaceutical Co., Ltd. romanized441

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

122 this week

AcceptedDrugApplicants
2025/05/20Import · Class 2.2 Tremelimumab注射液 · No verified English nameJXSL2500078 MedImmune LLC; AstraZeneca Investment (China) Co. Ltd.
2025/05/20Import · Class 2.2 度伐利尤单抗注射液 · No verified English nameJXSL2500077 MedImmune LLC; AstraZeneca Investment (China) Co. Ltd.
2025/05/20Import · Class 1 AZD1613注射液 · No verified English nameJXSL2500076 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/05/20Import · Class 2.4 氘可来昔替尼片 · No verified English nameJXHS2500059 Bristol-Myers Squibb Pharma EEIG; PATHEON INC.; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/05/20Import · Class 1 AZD5305 · No verified English nameJXHL2500119 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/05/20Import · Class 1 AZD5305 · No verified English nameJXHL2500118 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/05/20Import · Class 1 AZD5305 · No verified English nameJXHL2500117 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/05/20Import · Class 1 AZD5305 · No verified English nameJXHL2500116 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/05/20Generic · Class 3 Acetylcysteine TabletsCYHS2501825 Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized
2025/05/20Generic · Class 3 Bumetanide InjectionCYHS2501821 Chengdu Kang Tai Yuan Pharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/05/20Generic · Class 3 Paracetamol and Ibuprofen TabletsCYHS2501818 Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized; Zhejiang Hua Run San Jiu Zhong Yi Pharmaceutical Co., Ltd. romanized
2025/05/20Generic · Class 3 Atropine Sulfate InjectionCYHS2501817 Hubei Heng Di Pharma Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized
2025/05/20Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2501814 Hefei Yuan Zhi Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2025/05/20New drug · Class 1 GC012F注射液 · No verified English nameCXSL2500399 Gen Xi Bio Technology (Shanghai) Co., Ltd. romanized; Suzhou Gen Xi Bio Technology Co., Ltd. romanized
2025/05/20New drug · Class 1 注射用BC3195 · No verified English nameCXSL2500398 Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized
2025/05/20New drug · Class 1 注射用康替唑胺钠 · No verified English nameCXHS2500053 Shanghai Meng Ke Pharma Co., Ltd. romanized; Hainan Shuang Cheng Pharma Co., Ltd. romanized
2025/05/20New drug · Class 2.2 环孢素眼用凝胶 · No verified English nameCXHS2500052 Zhao Ke (Guangzhou) Yan Ke Drug Co., Ltd. romanized
2025/05/20New drug · Class 1 DC411151胶囊 · No verified English nameCXHL2500487 Hangzhou Minsheng Pharmaceutical Co., Ltd; Zhongguo Ke College Shanghai Drug Research Institute romanized
2025/05/20New drug · Class 1 DC411151胶囊 · No verified English nameCXHL2500486 Hangzhou Minsheng Pharmaceutical Co., Ltd; Zhongguo Ke College Shanghai Drug Research Institute romanized
2025/05/20New drug · Class 2.4 氟[18F]阿洛夫定注射液 · No verified English nameCXHL2500485 Jiangsu Hua Yi Technology Co., Ltd. romanized
2025/05/19Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2501810 Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized
2025/05/19New drug · Class 1 CM512注射液 · No verified English nameCXSL2500397 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2025/05/19New drug · Class 1 SCTB14注射液 · No verified English nameCXSL2500396 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2025/05/19New drug · Class 1 SCTB14注射液 · No verified English nameCXSL2500395 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2025/05/19New drug · Class 1 SM17单克隆抗体注射液(皮下注射) · No verified English nameCXSL2500394 Xing Lian Pharma (Suzhou) Co., Ltd. romanized
2025/05/19New drug · Class 1 CM512注射液 · No verified English nameCXSL2500391 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2025/05/19New drug · Class 2.2 QLM2012 · No verified English nameCXHL2500489 Qilu Pharmaceutical Co., Ltd.
2025/05/19New drug · Class 2.2 QLM2012 · No verified English nameCXHL2500488 Qilu Pharmaceutical Co., Ltd.
2025/05/17Import · Class 1 AMG 890 · No verified English nameJXHL2500115 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2025/05/17Import · Class 1 AMG 890 · No verified English nameJXHL2500114 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.

92 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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