YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 477 drug applications between 14 August 2026 and 20 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 54 drug names.
2026/08/14 – 2026/08/20
- New acceptances this week
- 477
- Drugs with new generic filings (by drug name, de-duplicated)
- 54
- Accepted this week, now under review
- 241
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
477filings, 71 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 283 |
| Generic | 71 |
| New drug | 70 |
| Import | 43 |
| Unspecified | 5 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 225 |
| TCM | 165 |
| Therapeutic biologic | 79 |
| Prophylactic biologic | 6 |
| 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
54 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 | Pregabalin Extended release Tablets | 3 | 1 | 13 |
| 3 | Pirfenidone Tablets | 2 | 2 | 5 |
| 4 | 氧(液态) · No verified English name | 2 | 2 | 13 |
| 5 | Landiolol Hydrochloride for Injection | 2 | 2 | 19 |
| 6 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 7 | 米诺地尔泡沫剂 · No verified English name | 2 | 2 | 2 |
| 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
274 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 15 | 3 | 0 |
| 2 | Shanghai Min Wei Bio Technology Co., Ltd. romanized | 14 | 1 | 0 |
| 3 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 10 | 3 | 0 |
| 4 | Eli Lilly and Company | 9 | 3 | 0 |
| 5 | Jilin Dao Jun Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 6 | Novo Nordisk A/S | 8 | 2 | 0 |
| 7 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 7 | 3 | 3 |
| 8 | F. Hoffmann-La Roche Ltd | 7 | 2 | 0 |
| 9 | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 10 | Tai Ji Group Sichuan Mian Yang Pharmaceutical Co., Ltd. romanized | 6 | 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
128 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/08/20Import · Class 1 | Ixoberogene Soroparvovec 注射液 · No verified English nameJXSL2600217 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/08/20Generic · Class 3 | Vincriscristine Sulfate InjectionCYHS2602076 | Shenzhen Wan Le Pharma Co., Ltd. romanized |
| 2026/08/20Generic · Class 3 | 米诺地尔泡沫剂 · No verified English nameCYHS2602075 | Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2026/08/20Generic · Class 3 | Azilsartan TabletsCYHS2602071 | Zhejiang Nord Pharmaceutical Co., Ltd |
| 2026/08/20Generic · Class 3 | 磷酸二氢钠磷酸氢二钠颗粒 · No verified English nameCYHS2602070 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2026/08/20Generic · Class 3 | 盐酸卡替洛尔滴眼液 · No verified English nameCYHS2602069 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2026/08/20Generic · Class 3 | Pirfenidone TabletsCYHS2602065 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized |
| 2026/08/20New drug · Class 1 | LP-003注射液 · No verified English nameCXSS2600130 | Tian Chen Biopharmaceuticals (Suzhou) Co., Ltd. romanized; Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/08/20New drug · Class 1 | 重组抗CD19m-CD3抗体注射液 · No verified English nameCXSL2600889 | Tian Mai Yuan He Biopharmaceuticals (Changchun) Co., Ltd. romanized |
| 2026/08/20New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2600888 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/08/20New drug · Class 2.2 | 瑞拉芙普α注射液 · No verified English nameCXSL2600887 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/08/20New drug · Class 1 | RGL-208注射液 · No verified English nameCXSL2600886 | Shanghai Rui Hong Di Pharmaceuticals Co., Ltd. romanized; Guangzhou Rui Ling Pharmaceuticals Co., Ltd. romanized |
| 2026/08/20New drug · Class 1 | SJ018注射液 · No verified English nameCXSL2600885 | Shen Ji Bio (Yi Xing) Co., Ltd. romanized |
| 2026/08/20New drug · Class 1 | SHR-4610注射液 · No verified English nameCXSL2600884 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/08/20New drug · Class 1 | 注射用RGL-232 · No verified English nameCXSL2600883 | Shanghai Rui Hong Di Pharmaceuticals Co., Ltd. romanized; Guangzhou Rui Ling Pharmaceuticals Co., Ltd. romanized |
| 2026/08/20New drug · Class 1 | RLX-2508注射液 · No verified English nameCXSL2600882 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized; Suzhou Tuo Jie Pharmaceuticals Co., Ltd. romanized |
| 2026/08/20New drug · Class 1 | IBI3038 · No verified English nameCXSL2600881 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/08/20New drug · Class 1 | HRS-4642注射液 · No verified English nameCXHL2601032 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/08/20New drug · Class 1 | HRS-7172片 · No verified English nameCXHL2601031 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/08/20New drug · Class 1 | HRS-7172片 · No verified English nameCXHL2601030 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/08/20New drug · Class 1 | HRS-7172片 · No verified English nameCXHL2601029 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/08/20New drug · Class 1 | HRS-7172片 · No verified English nameCXHL2601028 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/08/20New drug · Class 1 | HRS-2329片 · No verified English nameCXHL2601027 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/08/20New drug · Class 1 | HRS-2329片 · No verified English nameCXHL2601026 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/08/20New drug · Class 1 | HRS-2329片 · No verified English nameCXHL2601025 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/08/20New drug · Class 1 | HRS-2329片 · No verified English nameCXHL2601024 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/08/20New drug · Class 2.2 | 曲前列尼尔二乙醇胺吸入粉雾剂 · No verified English nameCXHL2601023 | Shanghai Shang Yao Rui Er Medicines Co., Ltd. romanized; Shanghai Xin Huang He Pharmaceutical Co., Ltd. romanized |
| 2026/08/20New drug · Class 1 | 普那布林注射用浓溶液 · No verified English nameCXHL2601022 | Da Lian Wan Chun Bu Lin Pharmaceuticals Co., Ltd. romanized |
| 2026/08/19Import · Class 3.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600075 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2026/08/19Import · Class 3.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600074 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
98 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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