YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 419 drug applications between 27 August 2025 and 2 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 109, covering 75 drug names.
2025/08/27 – 2025/09/02
- New acceptances this week
- 419
- Drugs with new generic filings (by drug name, de-duplicated)
- 75
- Accepted this week, now under review
- 107
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
419filings, 109 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 176 |
| Generic | 109 |
| New drug | 88 |
| Import | 32 |
| Unspecified | 9 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 281 |
| TCM | 65 |
| Therapeutic biologic | 63 |
| Biologic | 8 |
| Prophylactic biologic | 2 |
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
75 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 6 | 2 | 70 |
| 2 | 瑞维那新吸入溶液 · No verified English name | 3 | 3 | 53 |
| 3 | Ozagrel Sodium Injection | 3 | 1 | 3 |
| 4 | Ambroxol Hydrochloride Injection | 3 | 1 | 9 |
| 5 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 6 | Iguratimod Tablets | 2 | 2 | 23 |
| 7 | Mupirocin Ointment | 2 | 2 | 30 |
| 8 | Apalutamide Tablets | 2 | 2 | 18 |
| 9 | Rivaroxaban Tablets | 2 | 1 | 3 |
| 10 | 地氯雷他定口服溶液 · No verified English name | 2 | 1 | 26 |
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
228 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Jian Bin Pharmaceuticals Technology Co., Ltd. romanized | 12 | 11 | 0 |
| 2 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 10 | 8 | 0 |
| 3 | Eli Lilly and Company | 9 | 2 | 0 |
| 4 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 9 | 1 | 0 |
| 5 | Gui Lin Hua Run Tian He Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 6 | Novo Nordisk A/S | 6 | 2 | 0 |
| 7 | AstraZeneca AB | 5 | 3 | 0 |
| 8 | Takeda Canada Inc | 5 | 1 | 0 |
| 9 | Terumo Corporation Kofu Factory | 5 | 1 | 0 |
| 10 | Qilu Pharmaceutical Co., Ltd. | 5 | 1 | 0 |
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
154 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/09/02Import · Class 1 | 斯贝利单抗注射液 · No verified English nameJXSS2500118 | Otsuka Pharmaceutical Co. Ltd.; Vetter Pharma-Fertigung GmbH & Co. KG; Otsuka Beijing Research Institute |
| 2025/09/02Import · Class 2.2 | 本瑞利珠单抗注射液 · No verified English nameJXSS2500117 | AstraZeneca AB; Name not romanized |
| 2025/09/02Import · Class 2.2 | 本瑞利珠单抗注射液 · No verified English nameJXSS2500116 | AstraZeneca AB; Name not romanized |
| 2025/09/02Import · Class 2.1; 2.2 | MK-3475A注射液 · No verified English nameJXSL2500166 | Merck Sharp & Dohme B.V.; MSD R&D (China) Co. Ltd |
| 2025/09/02Import · Class 2.1; 2.2 | MK-3475A注射液 · No verified English nameJXSL2500165 | Merck Sharp & Dohme B.V.; MSD R&D (China) Co. Ltd |
| 2025/09/02Import · Class 1 | MK-1084片 · No verified English nameJXHL2500252 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2025/09/02Import · Class 1 | MK-1084片 · No verified English nameJXHL2500251 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2025/09/02Generic · Class 3 | Ondansetron Hydrochloride TabletsCYHS2503243 | CISEN PHARMACEUTICAL CO., LTD. |
| 2025/09/02Generic · Class 3 | Ondansetron Hydrochloride TabletsCYHS2503242 | CISEN PHARMACEUTICAL CO., LTD. |
| 2025/09/02Generic · Class 3 | Lanthanum Carbonate Hydrate GranulesCYHS2503235 | Hebei Hua Chen Pharma Group Co., Ltd. romanized |
| 2025/09/02Generic · Class 3 | Lanthanum Carbonate Hydrate GranulesCYHS2503234 | Hebei Hua Chen Pharma Group Co., Ltd. romanized |
| 2025/09/02Generic · Class 3 | 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English nameCYHS2503232 | Wuhan Shi Xiao Bo Bio Technology Co., Ltd. romanized; Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized |
| 2025/09/02Generic · Class 3 | 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English nameCYHS2503231 | Wuhan Shi Xiao Bo Bio Technology Co., Ltd. romanized; Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized |
| 2025/09/02Generic · Class 3 | Ozagrel Sodium InjectionCYHS2503227 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized |
| 2025/09/02Generic · Class 3 | Ozagrel Sodium InjectionCYHS2503226 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized |
| 2025/09/02Generic · Class 3 | Ozagrel Sodium InjectionCYHS2503225 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized |
| 2025/09/02Generic · Class 3 | Betahistine Dihydrochloride TabletsCYHS2503221 | Anhui Hai Tian Xin Heng Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized |
| 2025/09/02Generic · Class 3 | Betahistine Dihydrochloride TabletsCYHS2503220 | Anhui Hai Tian Xin Heng Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized |
| 2025/09/02Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2503219 | Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized |
| 2025/09/02Generic · Class 3 | Bupivacaine Hydrochloride InjectionCYHS2503217 | Jiangsu Chang Jiang Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2025/09/02Generic · Class 3 | Cyclophosphamide InjectionCYHS2503216 | Hu Zhou Ya Se Pharmaceutical Co., Ltd. romanized |
| 2025/09/02Generic · Class 3 | Cyclophosphamide InjectionCYHS2503215 | Hu Zhou Ya Se Pharmaceutical Co., Ltd. romanized |
| 2025/09/02New drug · Class 1.1 | 芪苓颗粒 · No verified English nameCXZL2500071 | Zheng Da Qing Chun Bao Pharma Co., Ltd. romanized |
| 2025/09/02New drug · Class 1.1 | 小儿安神补脑颗粒 · No verified English nameCXZL2500070 | China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.; Shenzhen Shi Zhong Hospital romanized; Shenzhen Shi Medicines Jian Yan Research Institute (Shenzhen Shi Medical Devices Jian Ce Center) romanized; Shenzhen Shi Zhong Yao Zhi Zao Ye Innovation Center Co., Ltd. romanized |
| 2025/09/02New drug · Class 1.4 | 吸附无细胞百白破灭活脊髓灰质炎和b型流感嗜血杆菌(结合)联合疫苗 · No verified English nameCXSL2500756 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2025/09/02New drug · Class 1 | BBM-C101注射液 · No verified English nameCXSL2500755 | Shanghai Mian Yi Bio Technology Co., Ltd. romanized |
| 2025/09/02New drug · Class 2.2 | 注射用瑞康曲妥珠单抗 · No verified English nameCXSL2500754 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/02New drug · Class 1 | HRS9531注射液 · No verified English nameCXHS2500114 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/09/02New drug · Class 1 | HRS9531注射液 · No verified English nameCXHS2500113 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/09/02New drug · Class 1 | HRS9531注射液 · No verified English nameCXHS2500112 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
124 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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