YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 475 drug applications between 1 June 2026 and 7 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 108, covering 73 drug names.
2026/06/01 – 2026/06/07
- New acceptances this week
- 475
- Drugs with new generic filings (by drug name, de-duplicated)
- 73
- Accepted this week, now under review
- 151
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
475filings, 108 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 243 |
| Generic | 108 |
| New drug | 78 |
| Import | 39 |
| Unspecified | 4 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 243 |
| TCM | 159 |
| Therapeutic biologic | 69 |
| Biologic | 2 |
| 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
73 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 甲硝唑凝胶 · No verified English name | 5 | 3 | 14 |
| 2 | Chloroprocaine Hydrochloride Injection | 4 | 3 | 10 |
| 3 | Dotinurad Tablets | 4 | 2 | 55 |
| 4 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 5 | Landiolol Hydrochloride for Injection | 3 | 3 | 19 |
| 6 | Sivelestat Sodium for Injection | 3 | 3 | 5 |
| 7 | Ilaprazole Enteric-coated Tablets | 3 | 3 | 26 |
| 8 | Dapagliflozin Tablets | 3 | 2 | 84 |
| 9 | Metformin Hydrochloride Extended-release Tablets | 3 | 1 | 10 |
| 10 | Mecobalamin Tablets | 2 | 2 | 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
288 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 16 | 12 | 0 |
| 2 | Eli Lilly and Company | 14 | 3 | 0 |
| 3 | Eli Lilly Nederland B.V. | 12 | 1 | 0 |
| 4 | Novo Nordisk A/S | 12 | 1 | 0 |
| 5 | Chengdu Hua Sen Ao Rui Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 6 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Qilu Pharmaceutical Co., Ltd. | 5 | 3 | 0 |
| 9 | Jiangsu En Hua Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory 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
152 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/06/05Import · Class 1 | NNC0487-0111注射液 · No verified English nameJXSL2600139 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/06/05Import · Class 1 | NNC0487-0111注射液 · No verified English nameJXSL2600138 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/06/05Import · Class 2.2 | 度伐利尤单抗注射液 · No verified English nameJXSL2600137 | Medlmmune LLC; AstraZeneca Investment (China) Co. Ltd. |
| 2026/06/05Import · Class 1 | NNC0487-0111注射液 · No verified English nameJXSL2600136 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/06/05Import · Class 1 | NNC0487-0111注射液 · No verified English nameJXSL2600135 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/06/05Import · Class 1 | NNC0487-0111注射液 · No verified English nameJXSL2600134 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/06/05Import · Class 1 | NNC0487-0111注射液 · No verified English nameJXSL2600133 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/06/05Import · Class 1 | NNC0487-0111注射液 · No verified English nameJXSL2600132 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/06/05Import · Class 1 | NNC0487-0111注射液 · No verified English nameJXSL2600131 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/06/05Import · Class 1 | NNC0487-0111注射液 · No verified English nameJXSL2600130 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/06/05Import · Class 1 | NNC0487-0111注射液 · No verified English nameJXSL2600129 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/06/05Import · Class 1 | NNC0487-0111注射液 · No verified English nameJXSL2600128 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/06/05Import · Class 1 | NNC0487-0111注射液 · No verified English nameJXSL2600127 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/06/05Generic · Class 3 | Sivelestat Sodium for InjectionCYHS2601320 | Chongqing Lai Mei Pharma Co., Ltd. romanized |
| 2026/06/05Generic · Class 3 | 维生素K?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2601318 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2026/06/05Generic · Class 3 | Loxoprofen Sodium Oral SolutionCYHS2601315 | Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanized |
| 2026/06/05Generic · Class 3 | Landiolol Hydrochloride for InjectionCYHS2601314 | Lang Tian Pharma (Hubei) Co., Ltd. romanized |
| 2026/06/05New drug · Class 1.2 | 注射用AS006 · No verified English nameCXZL2600053 | Zhongguo Ke College Shanghai Drug Research Institute romanized |
| 2026/06/05New drug · Class 1.2 | AS006 · No verified English nameCXZL2600052 | Zhongguo Ke College Shanghai Drug Research Institute romanized |
| 2026/06/05New drug · Class 1 | 注射用DXC016 · No verified English nameCXSL2600610 | Hangzhou Duo Xi Bio Technology Co., Ltd. romanized |
| 2026/06/05New drug · Class 1 | EX103注射液 · No verified English nameCXSL2600609 | Guangzhou Ai Si Mai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/06/05New drug · Class 1 | LM101注射液 · No verified English nameCXSL2600608 | Beijing Lian Li Zhong Da Medical Technology Co., Ltd. romanized |
| 2026/06/05New drug · Class 1 | SCTB41注射液 · No verified English nameCXSL2600607 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2026/06/05New drug · Class 1 | SCTB41注射液 · No verified English nameCXSL2600606 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2026/06/05New drug · Class 3.3 | 达雷妥尤单抗注射液(皮下注射) · No verified English nameCXSL2600605 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2026/06/05New drug · Class 1 | HY001N细胞注射液 · No verified English nameCXSL2600604 | He Yuan Bio Technology Co., Ltd. romanized; Guangdong He Yuan Biopharmaceuticals Co., Ltd. romanized |
| 2026/06/05New drug · Class 2.3 | YZEE03冲洗液 · No verified English nameCXHL2600676 | Yi Zhou Hai Yang Bio Technology (Shandong) Co., Ltd. romanized |
| 2026/06/05New drug · Class 1 | RZ-520雾化吸入溶液 · No verified English nameCXHL2600675 | Ning Kang Xiao Wei Biopharmaceutical (Zhejiang) Co., Ltd. romanized |
| 2026/06/05New drug · Class 1 | SYH2092注射液 · No verified English nameCXHL2600674 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2026/06/05New drug · Class 1 | NH302注射液 · No verified English nameCXHL2600673 | Jiangsu En Hua Pharma Co., Ltd. romanized |
122 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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