YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 516 drug applications between 12 August 2026 and 18 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 81, covering 57 drug names.
2026/08/12 – 2026/08/18
- New acceptances this week
- 516
- Drugs with new generic filings (by drug name, de-duplicated)
- 57
- Accepted this week, now under review
- 252
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
516filings, 81 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 310 |
| Generic | 81 |
| New drug | 66 |
| Import | 46 |
| Unspecified | 8 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 257 |
| TCM | 177 |
| Therapeutic biologic | 75 |
| Prophylactic biologic | 5 |
| 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
57 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Glucosamine Sulfate Capsules | 3 | 3 | 51 |
| 2 | 注射用磷酸左奥硝唑酯二钠 · No verified English name | 3 | 2 | 22 |
| 3 | 苯磺酸左氨氯地平片 · No verified English name | 3 | 2 | 45 |
| 4 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 5 | Pregabalin Extended release Tablets | 3 | 1 | 13 |
| 6 | 氧(液态) · No verified English name | 2 | 2 | 13 |
| 7 | Landiolol Hydrochloride for Injection | 2 | 2 | 19 |
| 8 | 醋酸地非法林注射液 · No verified English name | 2 | 2 | 8 |
| 9 | Sodium Ibandronate Injection | 2 | 1 | 4 |
| 10 | Levofloxacin Eye Drops | 2 | 1 | 16 |
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
285 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 | F. Hoffmann-La Roche Ltd | 13 | 3 | 0 |
| 3 | Jilin Gao Miao Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 4 | Eli Lilly and Company | 9 | 3 | 0 |
| 5 | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 8 | 8 | 2 |
| 6 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 8 | 4 | 4 |
| 7 | Novo Nordisk A/S | 8 | 2 | 0 |
| 8 | Xin Da Bio Technology Co., Ltd. romanized | 8 | 1 | 0 |
| 9 | Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized | 7 | 6 | 0 |
| 10 | AstraZeneca AB | 7 | 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
135 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/08/18Import · Class 1.1 | 艰难梭菌佐剂疫苗 · No verified English nameJXSL2600209 | Pfizer Inc.; Pfizer Investment CO Ltd. |
| 2026/08/18Import · Class 1 | LY900043注射液 · No verified English nameJXHL2600353 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/08/18Import · Class 1 | LY900043注射液 · No verified English nameJXHL2600352 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/08/18Import · Class 1 | LY900043注射液 · No verified English nameJXHL2600351 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/08/18Import · Class 1 | LY900043注射液 · No verified English nameJXHL2600350 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/08/18Import · Class 1 | LY900043注射液 · No verified English nameJXHL2600349 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/08/18Import · Class 1 | LY900043注射液 · No verified English nameJXHL2600348 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/08/18Import · Class 1 | LY900043注射液 · No verified English nameJXHL2600347 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/08/18Generic · Class 3 | Landiolol Hydrochloride for InjectionCYHS2602049 | Tianjin Tian Shi Li Zhi Jiao Pharma Co., Ltd. romanized |
| 2026/08/18Generic · Class 3 | Landiolol Hydrochloride for InjectionCYHS2602046 | Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanized |
| 2026/08/18Generic · Class 3 | Pirfenidone TabletsCYHS2602045 | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized |
| 2026/08/18New drug · Class 2.4 | 重组人血清白蛋白注射液 · No verified English nameCXSS2600127 | Shenzhen Pu Luo Ji Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Pu Luo Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/08/18New drug · Class 1 | BC008-1A注射液 · No verified English nameCXSL2600878 | Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized |
| 2026/08/18New drug · Class 1 | CG-BM1异体人骨髓间充质干细胞注射液 · No verified English nameCXSL2600877 | Guangzhou Sai Juan Bio Technology Co., Ltd. romanized |
| 2026/08/18New drug · Class 2.4 | 玛舒拉沙韦片 · No verified English nameCXHS2600119 | Jiangxi Ke Rui Pharma Co., Ltd. romanized |
| 2026/08/17Import · Class 1 | VAY736注射液 · No verified English nameJXSL2600208 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/08/17Import · Class 1 | ALPN-303注射液 · No verified English nameJXSL2600207 | Vertex Pharmaceuticals Incorporated; Name not romanized |
| 2026/08/17Import · Class 1 | CDR132L注射液 · No verified English nameJXHL2600346 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/08/17Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2602035 | Sichuan Qun Le Kang Pharma Co., Ltd. romanized; Jiangxi He Ying Pharma Co., Ltd. romanized |
| 2026/08/17Generic · Class 3 | 螺内酯片 · No verified English nameCYHS2602033 | Jin Wei Shi (Tianjin) Technology Co., Ltd. romanized; TIANJIN LISHENG PHARMACEUTICAL CO., LTD |
| 2026/08/17Generic · Class 3 | 螺内酯片 · No verified English nameCYHS2602032 | Jin Wei Shi (Tianjin) Technology Co., Ltd. romanized; TIANJIN LISHENG PHARMACEUTICAL CO., LTD |
| 2026/08/17Generic · Class 3 | Cetirizine Hydrochloride InjectionCYHS2602030 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized |
| 2026/08/17Generic · Class 3 | Bilastine Orally disintegrating TabletsCYHS2602029 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized |
| 2026/08/17Generic · Class 3 | 二硫化硒洗剂 · No verified English nameCYHS2602027 | Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized |
| 2026/08/17Generic · Class 3 | Indobufen TabletsCYHS2602023 | Shenzhen Shi Lang Bo Biopharmaceuticals Co., Ltd. romanized; Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized |
| 2026/08/17New drug · Class 1.1 | 天葛定眩颗粒 · No verified English nameCXZL2600077 | Sichuan Guang Da Pharmaceutical Co., Ltd. romanized |
| 2026/08/17New drug · Class 2.2 | 安尼妥单抗注射液 · No verified English nameCXSS2600126 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized; Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2026/08/17New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600125 | Zhi Tai Pharma (Tai Zhou) Co., Ltd. romanized |
| 2026/08/17New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600124 | Zhi Tai Pharma (Tai Zhou) Co., Ltd. romanized |
| 2026/08/17New drug · Class 1 | SHR-1139注射液 · No verified English nameCXSL2600876 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
105 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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