YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 460 drug applications between 16 August 2026 and 22 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 69, covering 51 drug names.
2026/08/16 – 2026/08/22
- New acceptances this week
- 460
- Drugs with new generic filings (by drug name, de-duplicated)
- 51
- Accepted this week, now under review
- 234
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
460filings, 69 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 264 |
| New drug | 72 |
| Generic | 69 |
| Import | 42 |
| Import re-registration | 7 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 218 |
| TCM | 148 |
| Therapeutic biologic | 81 |
| Prophylactic biologic | 10 |
| Biologic | 3 |
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
51 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Febuxostat Tablets | 4 | 2 | 12 |
| 2 | Glucosamine Sulfate Capsules | 3 | 3 | 51 |
| 3 | Brivaracetam Tablets | 3 | 1 | 19 |
| 4 | Pirfenidone Tablets | 2 | 2 | 5 |
| 5 | 氧(液态) · No verified English name | 2 | 2 | 13 |
| 6 | Landiolol Hydrochloride for Injection | 2 | 2 | 19 |
| 7 | 生理氯化钠溶液 · No verified English name | 2 | 2 | 17 |
| 8 | Aspirin Enteric-coated Tablets | 2 | 2 | 10 |
| 9 | Lactulose Oral Solution | 2 | 1 | 34 |
| 10 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
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
275 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanghai Min Wei Bio Technology Co., Ltd. romanized | 14 | 1 | 0 |
| 2 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 11 | 3 | 0 |
| 3 | Eli Lilly and Company | 8 | 2 | 0 |
| 4 | Novo Nordisk A/S | 8 | 2 | 0 |
| 5 | Pfizer Inc. | 7 | 4 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 2 | 0 |
| 7 | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 8 | Jilin Dao Jun Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 9 | AbbVie Inc. | 5 | 2 | 0 |
| 10 | Jilin Gao Miao Pharma Co., Ltd. romanized | 4 | 4 | 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
129 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/08/21Import · Class 3.1 | 20价肺炎球菌多糖结合疫苗 · No verified English nameJXSL2600221 | Pfizer Europe MA EEIG; Pfizer Investment CO. Ltd. |
| 2026/08/21Import · Class 1 | 注射用BMS-986525 · No verified English nameJXSL2600220 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/08/21Import · Class 2.2 | MK-3475A注射液 · No verified English nameJXSL2600219 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2026/08/21Import · Class 2.2 | MK-3475A注射液 · No verified English nameJXSL2600218 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2026/08/21Import · Class 1 | [111In]In-FL-261注射液 · No verified English nameJXHL2600359 | Full-Life Techinologies UK Limited; Shanghai Full-life Technologies Co. Ltd. |
| 2026/08/21Import · Class 1 | [225Ac]Ac-FL-261注射液 · No verified English nameJXHL2600358 | Full-Life Techinologies UK Limited; Shanghai Full-Life Technologies Co. Ltd |
| 2026/08/21Generic · Class 3 | Brivaracetam TabletsCYHS2602090 | Zhejiang Nord Pharmaceutical Co., Ltd |
| 2026/08/21Generic · Class 3 | Brivaracetam TabletsCYHS2602089 | Zhejiang Nord Pharmaceutical Co., Ltd |
| 2026/08/21Generic · Class 3 | Brivaracetam TabletsCYHS2602088 | Zhejiang Nord Pharmaceutical Co., Ltd |
| 2026/08/21Generic · Class 3 | 中性腹膜透析液(乳酸盐-G1.35%) · No verified English nameCYHS2602086 | Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2026/08/21Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2602085 | Hebei Guang Xiang Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2026/08/21Generic · Class 3 | Doxycycline Hyclate for InjectionCYHS2602083 | Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized |
| 2026/08/21Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2602082 | Shi Yao Yin Hu Pharmaceutical Co., Ltd. romanized |
| 2026/08/21Generic · Class 3 | Mesalazine Gastro-Resistant Prolonged-Release GranulesCYHS2602081 | Shanghai Hui Yong Pharmaceutical Co., Ltd. romanized |
| 2026/08/21New drug · Class 2.2 | YFZ-002 · No verified English nameCXZL2600079 | Su Zhou Yi Fan Pharma Co., Ltd. romanized |
| 2026/08/21New drug · Class 2.2 | YFZ-002 · No verified English nameCXZL2600078 | Su Zhou Yi Fan Pharma Co., Ltd. romanized |
| 2026/08/21New drug · Class 1 | 注射用奥帕替苏米单抗 · No verified English nameCXSS2600131 | Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized; Yan Tai Mai Bai Rui International Biopharmaceuticals Co., Ltd. romanized |
| 2026/08/21New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2600895 | Shenzhen Shi Yin Guan Bio Technology Co., Ltd. romanized |
| 2026/08/21New drug · Class 2.2 | 信迪利单抗注射液 · No verified English nameCXSL2600894 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/08/21New drug · Class 3.2 | 蛋白C · No verified English nameCXSL2600893 | Guangxi Lai Shi Biopharmaceutical Co., Ltd. romanized |
| 2026/08/21New drug · Class 1 | Pumitamig注射液 · No verified English nameCXSL2600892 | Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2026/08/21New drug · Class 2.2 | 注射用MK-2870 · No verified English nameCXSL2600891 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2026/08/21New drug · Class 2.2 | 注射用MK-2870 · No verified English nameCXSL2600890 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2026/08/21New drug · Class 2.2 | HRG2010胶囊 · No verified English nameCXHS2600121 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/08/21New drug · Class 2.2 | HRG2010胶囊 · No verified English nameCXHS2600120 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/08/21New drug · Class 2.2; 2.3; 2.4 | 纳曲酮利培酮植入剂 · No verified English nameCXHL2601038 | Shenzhen Shan Kang Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/08/21New drug · Class 1 | HJ065片 · No verified English nameCXHL2601037 | Hua Jian Wei Lai (Chengdu) Technology Co., Ltd. romanized |
| 2026/08/21New drug · Class 1 | HJ065片 · No verified English nameCXHL2601036 | Hua Jian Wei Lai (Chengdu) Technology Co., Ltd. romanized |
| 2026/08/21New drug · Class 1 | 奥莱泊肽注射液 · No verified English nameCXHL2601035 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2026/08/21New drug · Class 1 | 奥莱泊肽注射液 · No verified English nameCXHL2601034 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
99 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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