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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 431 drug applications between 9 July 2025 and 15 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 112, covering 76 drug names.

2025/07/09 – 2025/07/15

Period
2025/07/09 to 2025/07/15, 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
431
Drugs with new generic filings (by drug name, de-duplicated)
76
Accepted this week, now under review
79

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

431filings, 112 of them generic

By application type

Application typeFilings
Supplement190
Generic112
New drug91
Import27
Import re-registration9
Unspecified2

By drug type

Drug typeFilings
Chemical drug287
TCM79
Therapeutic biologic62
Biologic2
Prophylactic biologic1

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

76 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
2Empagliflozin Tablets4218
3Minoxidil Liniment4252
4Quetiapine Fumarate Extended-release Tablets410
5Guanfacine Hydrochloride Extended Release Tablets414
6瑞维那新吸入溶液 · No verified English name2253
7腺苷钴胺胶囊 · No verified English name228
8Ilaprazole Enteric-coated Tablets2226
9醋酸钠林格葡萄糖注射液(Ⅰ) · No verified English name222
10低钙腹膜透析液(乳酸盐-G1.5%) · 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

247 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized17130
2Sichuan Qing Shan Li Kang Pharma Co., Ltd. romanized13713
3Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized860
4Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized830
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized820
6Eli Lilly and Company720
7AstraZeneca AB630
8Celgene Corporation610
9Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized550
10Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.543

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

163 this week

AcceptedDrugApplicants
2025/07/15Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2502531 Hunan Xian Shi Pharmaceutical Co., Ltd. romanized
2025/07/15Generic · Class 3 Dexamethasone Sodium Phosphate InjectionCYHS2502529 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2025/07/15Generic · Class 3 Sodium Thiosulfate InjectionCYHS2502527 Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized
2025/07/15Generic · Class 3 辅酶Q10片 · No verified English nameCYHS2502526 Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Zhejiang Hao Ge Pharma Co., Ltd. romanized
2025/07/15New drug · Class 1 注射用AK138D1 · No verified English nameCXSL2500593 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2025/07/15New drug · Class 1 OVV-01注射液 · No verified English nameCXSL2500592 Shanghai Rong Rui Pharmaceuticals Technology Co., Ltd. romanized
2025/07/15New drug · Class 1 OVV-01注射液 · No verified English nameCXSL2500591 Shanghai Rong Rui Pharmaceuticals Technology Co., Ltd. romanized
2025/07/15New drug · Class 1 重组人源化抗HER2双特异性抗体注射液 · No verified English nameCXSL2500590 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2025/07/15New drug · Class 1 注射用MR001双特异性抗体 · No verified English nameCXSL2500589 Shenzhen Shi Mai Jia Rui Bio Technology Co., Ltd. romanized
2025/07/14Import · Class 1 IcoSema 注射液 · No verified English nameJXSL2500122 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2025/07/14Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2502518 TC Pharmaceuticals (Jiangsu) Co., Ltd
2025/07/14New drug · Class 2.2 恩朗苏拜单抗注射液 · No verified English nameCXSL2500588 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/07/14New drug · Class 2.2 QL2107注射液 · No verified English nameCXSL2500587 Qilu Pharmaceutical Co., Ltd.
2025/07/14New drug · Class 1 KDTV001注射液 · No verified English nameCXSL2500586 Wuhan Kai De Ji Nuo Bio Technology Co., Ltd. romanized
2025/07/14New drug · Class 1 注射用QLC5508 · No verified English nameCXSL2500585 Qilu Pharmaceutical Co., Ltd.
2025/07/14New drug · Class 1 EVM14注射液 · No verified English nameCXSL2500584 Yun Ding Xin Yao (Beijing) Pharmaceuticals Technology Co., Ltd. romanized
2025/07/14New drug · Class 2.3 BTP4507 · No verified English nameCXHL2500698 Jiangsu Nuo He Bi Tuo Xin Yao Research and Development Co., Ltd. romanized; Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized; Beijing Bai Ao Pharma Co., Ltd. romanized
2025/07/12Import · Class 1 AZD5335 · No verified English nameJXSL2500121 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/07/12Import · Class 2.4 Sulfur Hexafluoride Microbubbles for InjectionJXHL2500183 Bracco International B.V.; Bracco Imaging Medical Technologies (Shanghai) Co. Ltd
2025/07/12Import · Class 1 AZD9574 · No verified English nameJXHL2500182 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/07/12Import · Class 1 AZD9574 · No verified English nameJXHL2500181 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/07/12Import · Class 1 AZD9574 · No verified English nameJXHL2500180 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/07/12Import · Class 1 AZD9574 · No verified English nameJXHL2500179 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/07/12Generic · Class 3 盐酸西替利嗪干糖浆 · No verified English nameCYHS2502516 Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized
2025/07/12Generic · Class 3 Cimetidine InjectionCYHS2502505 Sen Miao (Shandong) Pharma Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized
2025/07/12Generic · Class 3 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2502504 Shanghai Zhao Hui Pharma Co., Ltd. romanized
2025/07/12Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2502503 Shandong Hua Yao Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2025/07/12Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2502502 Shandong Hua Yao Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2025/07/12Generic · Class 3 Minoxidil LinimentCYHS2502500 Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized
2025/07/12Generic · Class 3 Minoxidil LinimentCYHS2502499 Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized

133 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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