YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 449 drug applications between 3 January 2023 and 9 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 55 drug names.
2023/01/03 – 2023/01/09
- New acceptances this week
- 449
- Drugs with new generic filings (by drug name, de-duplicated)
- 55
- Accepted this week, now under review
- 0
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
449filings, 74 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 246 |
| Generic | 74 |
| New drug | 66 |
| Import | 36 |
| Import re-registration | 20 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 300 |
| TCM | 84 |
| Therapeutic biologic | 59 |
| Prophylactic biologic | 6 |
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
55 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Penicillin G Sodium For Injection | 3 | 1 | 2 |
| 2 | Dopamine Hydrochloride Injection | 3 | 1 | 3 |
| 3 | Ritonavir Tablets | 2 | 2 | 0 |
| 4 | Famotidine Injection | 2 | 2 | 8 |
| 5 | Phloroglucinol Injection | 2 | 2 | 2 |
| 6 | Lactulose Oral Solution | 2 | 1 | 34 |
| 7 | Fesoterodine Fumarate Prolonged-Release Tablets | 2 | 1 | 0 |
| 8 | 布比卡因脂质体注射液 · No verified English name | 2 | 1 | 7 |
| 9 | Metformin Hydrochloride And Empagliflozin Extended Release Tablets | 2 | 1 | 12 |
| 10 | Empagliflozin Tablets | 2 | 1 | 18 |
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
225 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized | 40 | 40 | 0 |
| 2 | Guo Da (Heilongjiang) Pharmaceutical Technology Co., Ltd. romanized | 16 | 16 | 0 |
| 3 | Guangzhou Bai Te Medical Yong Pin Co., Ltd. romanized | 9 | 6 | 0 |
| 4 | Jiangxi Xin Zheng Pharma Co., Ltd. romanized | 7 | 6 | 0 |
| 5 | Pfizer Europe MA EEIG | 6 | 3 | 0 |
| 6 | Novo Nordisk A/S | 6 | 2 | 0 |
| 7 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 5 | 5 | 0 |
| 8 | Novartis Pharma Schweiz AG | 5 | 3 | 0 |
| 9 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical 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
133 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/01/09Import · Class 1 | Balcinrenone达格列净胶囊 · No verified English nameJXHL2300004 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/01/09Import · Class 1 | Balcinrenone达格列净胶囊 · No verified English nameJXHL2300003 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/01/09Generic · Class 3 | 布比卡因脂质体注射液 · No verified English nameCYHS2300071 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/01/09Generic · Class 3 | 布比卡因脂质体注射液 · No verified English nameCYHS2300070 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/01/09Generic · Class 3 | Levofolinate Calcium for InjectionCYHS2300068 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2023/01/09Generic · Class 3 | Levofolinate Calcium for InjectionCYHS2300067 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2023/01/09Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2300066 | Le Pu Pharma Co., Ltd. romanized |
| 2023/01/09Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2300065 | Le Pu Pharma Co., Ltd. romanized |
| 2023/01/09New drug · Class 2.4 | 注射用重组促皮质素 · No verified English nameCXSL2300021 | Shanghai Duo Mi Rui Bio Technology Co., Ltd. romanized |
| 2023/01/08New drug · Class 1 | BRG01注射液 · No verified English nameCXSL2300020 | Guangzhou Bai Ji Biopharmaceutical Co., Ltd. romanized |
| 2023/01/08New drug · Class 1 | XZP-6877片 · No verified English nameCXHL2300038 | Xuan Zhu Bio Technology Co., Ltd. romanized; Shandong Xuan Zhu Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/01/08New drug · Class 1 | XZP-6877片 · No verified English nameCXHL2300037 | Xuan Zhu Bio Technology Co., Ltd. romanized; Shandong Xuan Zhu Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/01/08New drug · Class 1 | XZP-6877片 · No verified English nameCXHL2300036 | Xuan Zhu Bio Technology Co., Ltd. romanized; Shandong Xuan Zhu Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/01/08New drug · Class 1 | WXFL10030390片 · No verified English nameCXHL2300035 | Shanghai Jia Tan Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/01/08New drug · Class 1 | WXFL10030390片 · No verified English nameCXHL2300034 | Shanghai Jia Tan Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/01/08New drug · Class 1 | WXFL10030390片 · No verified English nameCXHL2300033 | Shanghai Jia Tan Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/01/08New drug · Class 1 | WXFL10030390片 · No verified English nameCXHL2300032 | Shanghai Jia Tan Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/01/08New drug · Class 1 | HS-10506片 · No verified English nameCXHL2300031 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/01/08New drug · Class 1 | HS-10506片 · No verified English nameCXHL2300030 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/01/08New drug · Class 1 | CGT-2201胶囊 · No verified English nameCXHL2300029 | Sheng Shi Tai Ke Biopharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2023/01/08New drug · Class 1 | CGT-2201胶囊 · No verified English nameCXHL2300028 | Sheng Shi Tai Ke Biopharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2023/01/07Import · Class 3.1 | 赖脯胰岛素注射液 · No verified English nameJXSS2300004 | Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd |
| 2023/01/07Import · Class 3.1 | 赖脯胰岛素注射液 · No verified English nameJXSS2300003 | Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd |
| 2023/01/07Import · Class 3.1 | 注射用Vonicog alfa · No verified English nameJXSS2300002 | Baxalta US Inc.; Takeda (China) International Trading Co. Ltd |
| 2023/01/07Import · Class 3.1 | 注射用Vonicog alfa · No verified English nameJXSS2300001 | Baxalta US Inc.; Takeda (China) International Trading Co. Ltd |
| 2023/01/07Import · Class 2.1 | RO7030816 · No verified English nameJXSL2300019 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/01/07Import · Class 2.1 | RO7030816 · No verified English nameJXSL2300018 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/01/07Import · Class 2.4 | Baricitinib TabletsJXHS2300006 | Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd |
| 2023/01/07Import · Class 2.4 | Baricitinib TabletsJXHS2300005 | Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd |
| 2023/01/07Import · Class 1 | BAY 2433334片 · No verified English nameJXHL2300002 | Bayer AG; Bayer Healthcare Company Ltd. |
103 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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